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					Asthma
The Challenge of Children, Minorities,
and Low-Income Populations




        Thomas Owens, MD
Asthma: A Chronic Lung
Disease
• Characterized by recurrent cough and
  wheeze that is increasing in prevalence
  among children
• From 1980 to 1996
  – the number of Americans afflicted with asthma
    more than doubled to 15 million
  – with children under 5 experiencing the highest
    rate of increase
        This constitutes an epidemic
Review of Asthma




                   A.D.A.M., 2007
Objectives
• Describe the highest risk asthma populations
• Outline the significant features of the asthma
  management guidelines
• Describe adherence issues and methods to
  overcome difficulties
• Describe new advances in the diagnosis and
  pharmacological treatments of asthma
Objectives
• Describe the highest risk asthma
  populations
• Outline the significant features of the asthma
  management guidelines
• Describe adherence issues and methods to
  overcome difficulties
• Describe new advances in the diagnosis and
  pharmacological treatments of asthma
 Prevalence in High-Risk
 Populations
Nearly 5 million children
(<5% population 18 & younger)

African-Americans &
Hispanic Americans
(Highest rates of asthma)

Urban areas with
poor living conditions
(near transportation and industrial activity)

Low SES (<$20,000/yr)                           (Carmago,2007)
(poor access to healthcare and education)       (Morris, 2007)
Children with Asthma
• Usually begins in early childhood (Carmago, 2007)
   – 80-90% have symptoms by age 6
   – > ½ develop by age 3
   – < 10 yrs. male-to-female ratio is 2:1
      • Between the ages of 18 and 54 years the ratio is
        reversed



                                           (University of Aberdeen, 2007)
  Ethnicity Prevalence
• Caucasian children lowest at risk (Sharma,2007)
  – African-Americans 44% higher
     • 5-8% have asthma at sometime
     • 20-25% of inner-city children
  – Hispanics 15% higher
     • 20-25% of inner-city children
• U.S. average prevalence:
  – 7.6%, with ethnic minority            Caucasian
                                          A fr ican A mer ican

    prevalence of 3-14%                   H ispanic
African-American Child
Hospitalizations
• African-American children are
  hospitalized 3 times more than
  Caucasians (Bolte, 2007)
  – 1998 statistics: African-Americans
    more than 4 times likely to die
  – Mortality rates doubled 1980 to 1996
  – More deaths occur in inner city areas
Mortality Rates in
Pediatric Asthma
• More than doubled between 1980 and 1996
  – disproportionate number of deaths occur in inner city areas

• There are 5,000 deaths annually from asthma
  – some have been linked to management failure (especially in
    younger persons)
  – highest mortality rates occur in adolescents
  – persons who have had prior asthmatic exacerbation
    requiring intubations are at significantly increased risk for
    subsequent fatal exacerbations (Morris, 2007)
Significant Factors in
Pediatric Asthma Deaths
• Inappropriate delay in seeking medical
  attention
• Limited access to care
• Under-use of anti-inflammatory agents
• Overuse of beta agonists (Morris, 2007)
Barriers to Healthcare: Inner
City Residents
• Inner city inhabitants may:
  –   low income
  –   medically underserved
  –   less likely to have routine doctor visits
  –   poor access to the availability of medications
      (Morris, 2007)



 The source of primary and follow-up care for
     this population is often in the hospital
            emergency department.
Barriers to Healthcare: Ethnic
Minorities
• Lower quality health care
  – even when insurance, age, income and severity
    of conditions are the same
• Tend to use inhaled corticosteroid
  suppressants less than Caucasians
• Results from cost, inadequate literacy or
  competing priorities
  – These patients also received less follow-up after
    hospital emergency department visits (Morris, 2007)
Barriers to Asthma
Management
• Asthma is a disease that requires
  maximum cooperation of the patient
  and family
• Parents must oversee a complicated
  regimen of inhalers, pills, and breathing
  exercises  (Morris, 2007)


  – this type of supervision and assistance
    may not be available in poverty situations
Cultural Asthma Research
• Cultural competence policies and other predictors of
  asthma care quality for Medicaid-insured children (Lieu,
  2004)

   – evaluated medical clinics serving primarily inner city
     patients
   – best management of asthma was rendered where:
          •   physicians and caregivers improved their communication skills
          •   were trained in cultural differences
          •   utilized bilingual or low-literacy instructions, posters, teaching
          •   medication feedback was encouraged
          •   asthma case managers were utilized
          •   ethnic minority caregivers were employed
Latino Populations
• Puerto Ricans having highest mortality
  rates
  – followed by Cuban Americans and
    Mexican Americans (Homa et al. 2000; Sly, 2006)
The Effect of Urbanization
• Asthma emergency visits account for approximately
  2% of all emergency visits
   – In urban centers acute asthma may comprise up to 10% of
     all emergency visits
• Worldwide, 130 million people have asthma
   – The prevalence is 8-10 times higher in developed,
     industrialized countries (like Canada, England, Australia,
     Germany and New Zealand; prevalence rate = 2-10%) than in the
     developing countries. (Morris, 2007)
   – In developed countries, the prevalence is higher in low
     income groups in urban areas and inner cities than in other
     groups
   – Prevalence increases as a developing country becomes
     more Westernized and urbanized
Environmental Factors
• Exposure to maternal environmental
  tobacco smoke
  – which during pregnancy or the first year
    appears to predispose children to reactive
    airway disease
• Efforts to mitigate cockroach and mold
  reduced symptoms successfully and
  significantly for urban children  (Morgan et al., 2004)
Status Asthmaticus
• Appears to be on the rise
• Several retrospective studies reflect an
  increase in hospital admissions
  – particularly in those younger than 4 years
• Fewer hospital and emergency visits
  are needed in children using inhaled
  corticosteroid therapy
Urbanization Pollution
• Main contributor to the development of
  this disease
  – Gasoline (car) & diesel fuel (truck)
    combustion engines produce similar and
    yet different types of respiratory toxins
    (Pandya, 2001)
Gasoline Exhaust
• Produces known pollutants and several
  components of air pollution have been linked
  to asthma
• U.S. Clean Air Act requires the EPA to
  monitor:
  – nitrogen dioxide, sulfur dioxide, lead, carbon
    monoxide and ozone particulate matter (both
    PM(10 microns (um)) and PM(2.5)
  – diesel exhaust and diesel exhaust particles
    (DEPs) also appear to play a role in respiratory
    and allergic diseases (Pandya, 2001)
Diesel Exhaust
• Smog-forming and toxic air pollutant
  vapors and gases that you get when
  you burn gasoline
  – also composed of small particles of
    carbon, known as fine particulate matter
    and also referred to as
       Diesel Exhaust Particles (DEPs)
                                 (Johnson, 2007; Graham, 2007)
Diesel Particulates
• EPA classifies and measures these
  particulate matter according to their size
   – (PM2.5 = 2.5 microns (micromenter, um), PM 10
     = 10 microns)
• Unfortunately, the average diameter of diesel
  particulates is 0.2 microns, and nearly 94%
  of diesel particulates have diameters less
  than 2.5 micrometers (um) (Johnson, 2007; Graham, 2007)
Tiny Toxins




              EPA, 2007
DEPs
• Hundreds of chemicals adsorbed to their
  surfaces
• Cooked but unburned hydrocarbons could
  combine in thousands of combinations or
  permutations
  – are large, complex, carbon-ringed, planar, lipid
    soluble
  – similar to those we find in nature or design to
    penetrate the cell walls and enter the nucleus to
    interact with DNA (Pandya, 2001)
DEPs
• Bind to airborne allergens and other
  debris
  – may alter these complex organic allergen
    molecules further (Pandya, 2001)

One could not design a more effective
  delivery method or toxic product to
    enter the deepest of our lungs
Diesel Emissions
• Include over 40 substances that are listed by
  the EPA as hazardous air pollutants
• Federal agencies have classified diesel
  exhaust as a probable human carcinogen
• Benzene, an important component of the fuel
  and exhaust
  – is designated to be a known human carcinogen
    (Pandya, 2001)
Polyaromatic Hydrocarbons
• Contain larger, more complex
  – (anthracene, fluoranthene, pyrene, phenanthrene)
• In addition, DEPs contain
  – aldehydes (formaldehyde, acetaldehyde,
    acrolein), benzene, 1,3-butadiene, polycyclic
    aromatic hydrocarbons (PAHs), nitro-PAHs and
    hundreds of others

    Diesel exhaust ranks among the air
    pollutants that EPA believes pose the
      greatest public health risks      (Pandya, 2001)
Diesel Exhaust Components
• Genotoxic and mutagenic
  – can produce symptoms of allergy
    • including inflammation and irritation of airways
• Exposure to diesel exhaust can cause
  lung damage and respiratory problems
  – diesel exhaust can also exacerbate
    asthma and existing allergies
  – long-terms exposure is thought to increase
    the risk of lung cancer   (Pandya, 2001)
Children & Air Pollution
 There is no known safe level of exposure to
    diesel exhaust for children, especially
         those with respiratory illness
• May be more susceptible to air pollution
  – they breathe 50 % more air per lb. of body weight
    than adults
• May be especially susceptible to DEPs due
  to the small size of the particle
  – Smaller particles are able to penetrate children’s
    narrower airways reaching deeply within the lung,
    where they are more likely to be retained(Pandya, 2001)
DEPs
• DEPs act as generic respiratory irritant at
  high concentrations
• At lower levels:
   – DEPs act as pro-inflammatory agents
   – promote release of specific cytokines,
     chemokines, immunoglobulins, and oxidants in
     the upper and lower airway
   – DEPs cause formation of reactive oxygen species
     that trigger pro-inflammatory cytokine release
     (Takizawa, 2007)
Immunologic Evidence
• May help explain the epidemiologic
  studies indicating that children living
  along major trucking thoroughfares are
  at increased risk for:
  – asthmatic and allergic symptoms
  – more likely to have objective evidence of
    respiratory dysfunction(Pandya, 2001)
New & Emerging Factors
U.S. Trends in Diesel Fuel
Consumption

30 Billion Gallons Per Year

This figure demonstrates a 45%
increase in diesel fuel consumption in
the U.S. over the past decade.

As newer diesel engines emit less
pollution, total pollution may still
increase in response to increasing
numbers of vehicles on the highway,
and increasing miles driven by diesel    Wargo, 2002
vehicles.
School Bus Study Statistics
• U.S. nearly 600,000 school buses transport 24
  million students to school daily
• Each year buses travel 4.3 billion miles
   – nearly 10 billion school bus rides
   – students will spend 180 hours on buses each year
   – children spend 3 billion hours on school buses each year
• More than 99% of U.S. school buses are powered by
  diesel fuel
• Fine particulate concentrations measured on buses
  in this study were often 5-10 times higher than
  average levels (Morris, 2007)
School Bus DEPs
• Levels of DEP often higher under certain
  circumstances: (Morris, 2007)
  –   were idling with windows opened
  –   ran through their routes with windows closed
  –   moved through intense traffic
  –   queued to load or unload students while idling
• Some studies show there would have been
  less exposure if you ride in the vehicle
  directly behind the bus than to ride in it
NRDC & Coalition for Clean
Air Study (2001)
• Shows that children who ride a diesel school
  bus may be exposed to up to four times
  more toxic diesel exhaust than someone
  traveling in a car directly behind it
• Excess exhaust levels on school buses were
  23 to 46 times higher than levels considered
  to be a significant cancer risk
  – according to the U.S Environmental Protection
    Agency and federal guidelines (Morris, 2007)
Additional Causes of Asthma
• Exposure to:
  – passive smoking
  – changes in exposure to environmental allergens
     • cockroaches, house dust mites, and the mold Alternaria
       Tenuis
     • other aeroallergens like pet dander, gas and wood-
       burning stoves and tobacco smoke
  – viral respiratory infections
     • caused by respiratory syncytial virus
     • possibly rhinovirus are a significant risk factor for the
       development of childhood wheezing in the first decade
       of life (Morris, 2007)
Chronic Noise Levels
• During sleep caused stress and
  resulted in higher cortisol levels in the
  first half of the night
• Noise may have an adjuvant effect on
  the pathogenesis of allergies
Genetics
• Found more often in patients with a
  personal or family history of atopy
• Family history of asthma (Risk)
  – 7% if neither parent has asthma
  – 20% if one parent has asthma
  – 64% if both parents have asthma (Chin, 2001)
Allergic March
• Infants exhibiting
  – atopic dermatitis
  – food intolerance
• Followed in time by allergic
  rhinoconjunctivitis
• Ending with development of asthma
Hygiene Hypothesis
• Proposes that newborns are armed with an
  immune system ready to respond to natural
  environmental and infectious stimuli
• If not exposed to these
  – the balance of T lymphocytes will be tilted
    towards a more ‘angry’ reactive population TH2
  – as opposed to a ‘relaxed’ TH1 population with all
    their cytokine messenger signal proteins
Measles Infection
• BCG vaccine administration
• Hepatitis A seropositivity
• Other stimuli that increase production
  of interferon-gamma
• IL-12 may inhibit the TH2 allergic
  response
Increased Atopy & Asthma
• Increased atopy and asthma associated with:
   – Vaccinations, fewer childhood infections, liberal use of
     antibiotics, more processed food in diets, smaller families,
     and less exposure to day care environments
   – Prevalent in western Germany, while bronchitis from power
     plants is more common in eastern Germany
• Chinese from Hong Kong had higher atopy/allergy
  levels than those living on the mainland
• Traffic police officers had higher atopy/allergy levels
  than those with desk jobs (Polosa, 2002)
Further Asthma Study Results
• Twins raised separately
   – farm-reared sibs had lower asthma levels than
     town-raised sibs
• Asthma-free areas are present in certain sub-
  Saharan areas
   – Somalia, where hookworm disease is endemic
• The parasitic system (eosinophiles) is fully
  engaged
Questions
• Could it be that the reactive immune
  system engages what it has available,
  (eg. cockroach, mold, cat antigens)?

• And the adjuvant effect of air pollution
  and DEPs turns on the immune
  reaction to a high level?
Let’s Review!
Children may be more susceptible to
 diesel exhaust particles (DEPs)
 because:
              A. Small size of the
                  DEP particles
              B. Pro-inflammatory
                  agents in the DEPs
              C. High breathing rate
Objectives
• Describe the highest risk asthma populations
• Outline the significant features of the
  asthma management guidelines
• Describe adherence issues and methods to
  overcome difficulties
• Describe new advances in the diagnosis and
  pharmacological treatments of asthma
National Asthma Education &
Prevention Program (NAEPP)
• National Heart, Lung, and Blood
  Institute (NHLBI) of the National
  Institutes Health has assembled:
     • Best practice guidelines for diagnosis and
       treatment of asthma
  – 2007 revision available:
     • http://www.nhlbi.nih.gov/guidelines/asthma/epr
       3/resource.pdf
Asthma Diagnosis
• Confirmed with recurrent wheezing,
  coughing, dyspnea
  – Objective PEFR reversibility with
    medication
• Asthma staging helps define
  management, continued monitoring of
  symptoms
  – PEFR helps adjust medication
Goals of Treatment
1. Reduce wheeze and cough
2. Reduce the risk and number of acute
   exacerbations
3. Minimize adverse effects
  – medications
  – sleep disturbances
  – absences from school
NAEPP Effective Asthma
Management Components
1. Objective measurement of lung
   function
2. Environmental control measures
3. Comprehensive pharmacology
   therapy
4. Patient education
Peak Flow Meter
• Peak flow readings (PEFR) twice daily
  and as needed
  – Green > 80%
    • Okay
  – Yellow 50 - 80%
    • Action plan
  – Red < 50%
    • Emergency call
Digital Peak Flow Meter
• Electronic peak flow meters
  – will collect and monitor the data for the patient
  – data can be reviewed manually or electronically
• Results can be downloaded to a computer
  and produced in a graph or tabular format
  – ability to track and trend data




                                  Microlife Digital Peak Flow Meter, 2007
Indoor Pollutants




                    (northernnaturals.com, 2007)
Environmental Control
• Removal of carpeting and the use of pillow
  and mattress covers
   – However, recent evidence from better quality
     studies has shown that dust-mite avoidance
     measures did not improve symptoms or reduce
     medication use in adults with moderate to severe
     asthma.
• Air filtration systems
   – There is insufficient evidence to recommend for or
     against the use of air filtration units to reduce
     allergen levels in an effort to improve asthma
     symptoms.          Halken, et al., 2003; Woodcock,, et al., 2003; Terreehorst,, et al., 2003;
                                     Kilburn, 2004
Other Allergen Controls
• Cockroach trappings
• Remove moisture to lessen mold
• Washing pets
   – cats twice a week
• Skin testing
• Immunotherapy
                Halken, et al., 2003; Woodcock,, et al., 2003; Terreehorst,, et al., 2003;
                Kilburn, 2004
Long-Term Management of Asthma in Children
                     Go into objective
                                                                                                                                                      Medications
Asthma                                                                                                                                                required to maintain
classification*           Symptom frequency Lung function†                                                                                            long-term control
Mild intermittent                                 Daytime: 2 days per week                          PEF or FEV1: 80 percent                           No daily medication needed
                                                  or less                                           or more of predicted
                                                  Nighttime: 2 nights per                           function
                                                  month or less
Mild persistent                                   Daytime: more than 2                              PEF or FEV1: 80 percent                           Low-dosage inhaled
                                                  days per week, but less                           or more of predicted                              corticosteroid delivered by
                                                                                                                                                      nebulizer or metered-dose
                                                  than 1 time per day                               function
                                                                                                                                                      inhaler with holding chamber,
                                                  Nighttime: more than 2                                                                              with or without a face mask, or
                                                  nights per month                                                                                    by dry-powder inhaler in
                                                                                                                                                      children 5 years and younger

Moderate persistent                               Daytime: daily                                    PEF or FEV1: 60 to 80                             Children 5 years and younger:
                                                  Nighttime: more than 1                            percent of predicted                              low-dosage inhaled
                                                                                                                                                      corticosteroid and long-acting
                                                  night per week                                    function
                                                                                                                                                      beta2 agonist or medium-
                                                                                                                                                      dosage inhaled corticosteroid
                                                                                                                                                      Children older than 5 years:
                                                                                                                                                      low- to medium-dosage
                                                                                                                                                      inhaled corticosteroid and
                                                                                                                                                      long-acting inhaled beta2
                                                                                                                                                      agonist.

Severe persistent                                 Daytime: continual                                PEF or FEV1: 60 percent                           High-dosage inhaled
                                                  Nighttime: frequent                               or less of predicted                              corticosteroid and long-acting
                                                                                                                                                      beta2 agonist
                                                                                                    function
PEF = peak expiratory flow; FEV1 = forced expiratory volume in one second. *-Clinical features before treatment or adequate control. †-Lung function measurements are used only in patients older
than five years. Adapted from National Asthma Education and Prevention Program. Expert panel report: guidelines for the diagnosis and management of asthma: update on selected topics, 2002.
Bethesda, Md.: U.S. Department of Health and Human Services, Public Health Service, National Institutes of Health, National Heart, Lung, and Blood Institute, 2003; NIH publication no. 02-
Usual Dosages for Quick-Relief Asthma Medications
Medication                                                           Dosage Form                                                         Child Dosage*
Inhaled medications
                                                                     HFA MDI with spacer: 90 mcg per puff, 200                           1 to 2 puffs every 4 to 6 hours as
Albuterol (Proventil)                                                puffs                                                               needed.
                                                                     Nebulizer solution: 5 mg per mL (0.5                                0.05 mg per kg (minimum 1.25 mg,
                                                                     percent), 3.5 mg per 3 mL, 1.25 mg per 3                            maximum 2.5 mg) in 3 mL of saline
                                                                     mL, 0.63 mg per 3 mL                                                every 4 to 6 hours.
                                                                     MDI with spacer: 18 mcg per puff, 200 puffs                         1 to 2 puffs every 6 hours
Ipratropium (Atrovent)
                                                                     Nebulizer solution: 0.25 mg per mL (0.025                           0.25 to 0.5 mg every 6 hours
                                                                     percent)
                                                                     Nebulizer solution: 0.31 mg per 3 mL, 0.63                          0.025 mg per kg (minimum 0.63 mg;
Levalbuterol (R-albuterol,                                           mg per 3 mL, 1.25 mg per 3 mL                                       maximum 1.25 mg) every 4 to 8
Xopenex)                                                                                                                                 hours

Systemic corticosteroids
                                                                     2-, 4-, 8-, 16-, and 32-mg tablets                                  0.25 to 2 mg per kg in the morning
Methylprednisolone                                                                                                                       or every other day, as needed for
(Medrol)                                                                                                                                 control
                                                                                                                                         Short-course "burst”: 1 to 2 mg per
                                                                                                                                         kg per day (maximum 60 mg per
                                                                                                                                         day) for 3 to 10 days
                                                                     5-mg tablets                                                        Same as methylprednisolone
Prednisolone (Delta-Cortef)                                          Syrup: 5 mg per 5 mL, 15 mg per 5 mL
                                                                     1-, 2.5-, 5-, 10-, 20-, and 50-mg tablets                           Same as methylprednisolone
Prednisone                                                           Syrup: 5 mg per mL, 5 mg per 5 mL
HFA = hydrofluoroalkane; MDI = metered dose inhaler. *-Dosages are for children 12 years or younger unless otherwise specified. Adapted from National Asthma Education and Prevention Program.
Expert panel report: guidelines for the diagnosis and management of asthma: update on selected topics, 2002. Bethesda, Md.: U.S. Department of Health and Human Services, Public Health
Service, National Institutes of Health, National Heart, Lung, and Blood Institute, 2003. NIH publication no. 02-5074:120-1.
Let’s Review!
Part of the treatment for all 4 levels of
 asthma include:
 A.   Quick acting beta2 agonist
 B.   Leukotriene inhibitors
 C.   Theophylline
 D.   Long-acting beta2 agonist
Objectives
• Describe the highest risk asthma populations
• Outline the significant features of the asthma
  management guidelines
• Describe adherence issues and methods
  to overcome difficulties
• Describe new advances in the diagnosis and
  pharmacological treatments of asthma
Adherence Issues
• The patient’s understanding of asthma
  treatment and exacerbating factors is
  key to asthma control

       Patient education is key in
          this chronic disease
Prevalence Methods
• Education
   – Patient and caregiver empowerment
• Emphasize controller medications
   – Enact an action plan
      • (Patients do not like to take meds when they are feeling well)
• Overcome cultural and communication barriers
   – Use available tools
• Clean Air Act
   – Now LAW
• Pollution activism
   – Where you live!
Asthma Tool Kit
• Inner City Asthma Intervention (NIH)
  – www.achp.org
    • Select ACHP foundation
    • Then click “tool kit”


       Offers advice based on
          “best practices”
Cross-Cultural Competence
Communication Skills
• Promote bilingual or illiterate education
  – Handouts, posters, etc.
• Ethnic minority caregivers-language
  ability, understand cultural barriers
  – Highly important!!
• Emphasize controller medications
  – Monitor beta2 agonists (Lieu, 2004)
Encouraging Action
• Case managers
  – reports to clinicians
  – provide support for self-care
  – use asthma management guidelines
• Encourage patient empowerment & self-
  management with feedback
• Encourage
  – primary care access, continuity, coordination
        Managed care can support and
           benefit from this activity
                                             (Lieu, 2004)
Educational Empowerment
•   Recognize and avoid triggers
•   Understand use of prescribed medications
•   Proper use of inhalation devices
•   Importance of compliance and monitoring:
     – shown to improve lung function
     – decrease school absenteeism and visits to the emergency
       department
     – children with moderate to severe asthma receive the most
       benefit from educational programs                (Haby, 2004)

       However, education for children who have received
       emergency department care for asthma does not reduce
       subsequent emergency department care, hospitalizations,
       or unscheduled doctor visits.
Let’s Review!
Features of best practice asthma
 management for all persons include:
 A.   Education in your language about disease process
      and methods of monitoring and treatment
 B.   Peak flow meter education and usage in disease
      monitoring and treatment
 C.   Action plan based on PEFR
 D.   Follow up for disease Rx adjustment as needed
Objectives
• Describe the highest risk asthma populations
• Outline the significant features of the asthma
  management guidelines
• Describe adherence issues and methods to
  overcome difficulties
• Describe new advances in the diagnosis
  and pharmacological treatments of
  asthma
Latest Rx Advancements
• Rescue beta2 agonists
  – Use MDI with spacer-paper cup or
    plastic soda bottle if must    (NAEPP, 2002)

    • (as good as nebulizer)
      **Use facemasks in under 5




                               (Cleveland Clinic Health System, 2007)
Latest Rx Advancements
• More severe attacks
  – Use anticholinergics with beta2
    agonists                               (NAEPP, 2002)




                             (www.asthme-queec.ce, 2007)
Latest Rx Advancements
• To keep controller inhaled steroids
  at lowest required dose
  – Use leukotriene modifiers and               (NAEPP, 2002)

    nedocromil




                      (www.asthme-queec.ce, 2007)
Latest Rx Advancements
• To reduce the likelihood of hospital
  admission                      (NAEPP, 2002)

  – Give oral corticosteroids early during
    an acute asthma exacerbation
       • (i.e., within 45 minutes of the onset of
         symptoms)



   (www.asthme-queec.ce, 2007)
Oral Corticosteroids
• More effective than inhaled or nebulized
  corticosteroids
   – children hospitalized with severe acute asthma
• Treatment of acute flares of asthma with repeated
  short courses of oral corticosteroids       (NAEPP, 2002)
   – (at a dose of 1-2 mg per kg per day)
   – do not appear to cause any lasting changes in bone
     metabolism, bone mineralization, or adrenal function

  No evidence that intravenous corticosteroids are any
   more effective than oral corticosteroids in children
      with an intact and functioning digestive tract
Inhaled Corticosteroids
• High doses reduce hospital admission
  rates
  – In patients with acute asthma   (Courtney, 2005)




  However, there is insufficient evidence
   that inhaled corticosteroids alone are
     as effective as systemic steroids
Inhaled Corticosteroids
• As a single agent in a medium dosage are more
  effective than:
   – Inhaled long-acting beta2 agonists
   – Inhaled nedocromil (Tilade), and leukotriene inhibitors
       • (In improving asthma symptoms and lung function in children
         with mild to moderate asthma)
• Use of maintenance inhaled corticosteroids
   – Less use of bronchodilators and oral corticosteroids in
     patients using reduced growth velocity            (NAEPP, 2002)


  However, multiple studies have found no evidence
  that children treated prophylactically with inhaled
  corticosteroids fail to reach their full adult height.
Inhaled Corticosteroids
• Unlike adults, children whose asthma is
  inadequately controlled with standard
  dosages of inhaled corticosteroids
  have:
  – not been shown to benefit from the
    addition of a long-acting beta2 agonist
  – or from an increase in the dosage of
    inhaled corticosteroids
                                        (NAEPP, 2002)
Rx Research Findings
• Doubling the dosage of beclomethasone
   – did not change objective measures of lung function
   – or symptom scores but did result in a significant reduction of
     growth velocity                                            (NAEPP, 2002)

  Some benefit can be achieved with the addition of oral
  theophylline, but long-term effects have not been assessed.

• A brief, four-week study of oral montelukast
  (Singulair) added to standard dosages of inhaled
  budesonide (Rhinocort Aqua) in children whose
  asthma was not adequately controlled demonstrated:
   – improved lung function
   – reduction in the number of days with asthma exacerbations
Leukotriene Inhibitors
• Studies have shown that:
   – optimizing the dosage of inhaled corticosteroids provides
     better control of asthma than oral montelukast
• However another study found:
   – montelukast and inhaled corticosteroids were equally
     effective
       • possibly because of significantly better adherence with oral
         montelukast therapy
• Compared with placebo:
   – oral montelukast reduces
       • total daily use of beta2 agonists
       • the need for rescue oral corticosteroids
       • daytime symptom scores
                                            Ducharme & Di Salvio, 2004; Knorr et. at.,
                                               1998, 2001, 2003
Nedocromil & Cromolyn
• Inhaled nedocromil reduces:
   –   asthma symptom scores
   –   asthma severity
   –   bronchodilator use
   –   improves lung function compared with placebo
   –   However, it is not as effective as inhaled corticosteroids
• There is insufficient evidence to recommend
  prophylactic treatment with inhaled cromolyn (Intal)
  in children
   – Although it has been studied for use in children with
     asthma, it is less effective than inhaled corticosteroids in
     improving symptoms and lung function             Armenio, 1993; Tasche, 2000
Levalbuterol R-albuterol
(Xopenex)




                       (xopenex.com, 2007)
Levalbuterol R-albuterol
(Xopenex)
• Bronchodilator that contains R and S isomers
  of albuterol
  – The R-albuterol is responsible for the bronchodilator effect
  – The S-albuterol provides no benefit and may be responsible
    for the albuterol side effects
• Several pediatric studies have supported the
  use of levalbuterol over racemic albuterol
  – (increase FEV1, more favorable safety profile with fewer
    side effects)
                                                            (Carl, 2003)
  – Two conflicting studies do not support these findings
    Overall, a review of levalbuterol for the treatment of asthma in
    children found no clinically significant advantage over racemic
    albuterol.
Omalizumab (Xolair)




                      (Xolair.com, 2007)
Omalizumab (Xolair)
• Recombinant DNA-derived humanized IgG
  monoclonal antibody that selectively binds to human
  immunoglobulin E (IgE)
   – Inhibits the binding of IgE to the high-affinity IgE receptor on
     the surface of mast cells and basophils, limiting release of
     allergic mediators

   – Omalizumab is approved for use in children 12 years and
     older with moderate to severe persistent asthma
       • who have a positive skin test or in vitro reactivity to a perennial
         aeroallergen
       • and whose symptoms are inadequately controlled with inhaled
         corticosteroids                                         (Corren, 2003)
Omalizumab (Xolair)
• In children with moderate to severe asthma it
  reduces the rate of serious asthma exacerbations
   – and the need for physician or emergency department visits
     and hospitalizations
   – improves asthma quality-of-life scores
• Although this new agent seems promising, its use is
  likely to be limited because it has an estimated cost
  of $10,000 per patient per year
   – Its use may be cost-effective if limited to allergic asthmatics
     who are poorly controlled on maximal therapy
   – and who are hospitalized five or more times (or for 20 days
     or longer) per year
                                                         (Corren, 2003)
Sublingual Immunotherapy
(SLIT)




              (www.allergycapital.com, 2007)
Sublingual Immunotherapy
(SLIT)
• Improves asthma symptoms and reduces
  medication use compared with placebo in
  children with asthma
  – Who are allergic to house dust mites and in
    children with allergic rhinitis that is related to a
    variety of common inhalant allergens
                                                  (Courtney, 2005)


  It appears to be safe, with unwanted effects
  being as low as 9.6% and no life-threatening
            adverse effects reported.
Sublingual Immunotherapy
(SLIT)
• However, SLIT has not been compared
  directly with standard immunotherapy
  – While it is a procedure and therefore is not
    regulated by the U.S. Food and Drug
    Administration (FDA), the extracts used for SLIT
    are FDA-approved for diagnosis and injectable
    immunotherapy only
                                             (Courtney, 2005)

• Use of FDA-approved allergic extracts for
  SLIT is an off-label use
  – Health insurers consider SLIT investigational
    and do not cover its use
Long-Acting Beta2 Agonists




                     (www.asthme-queec.ce, 2007)
Long-Acting Beta2 Agonists
• Compared with placebo, salmeterol (Serevent)
  produces improved lung function in children
   – but there is conflicting evidence about whether it reduces
     the use of rescue or short-acting beta2 agonists
• Associated with a significant increase in bronchial
  hyper-reactivity compared with inhaled
  corticosteroids
• Not recommended for use as monotherapy in
  children with asthma
   – However, limited evidence from a single three-month study
     with 210 patients shows that the combination of a long-
     acting beta2 agonist and inhaled corticosteroids may
     increase the number of symptom-free days
                                                       (Simons, 1997)
Oral Theophylline
• Initially seemed promising in the prophylactic
  treatment of childhood asthma
  – When compared with placebo
     • significantly increased the mean morning peak
       expiratory flow rate
     • reduced the mean number of acute nighttime attacks
       and doses of bronchodilator used


• However, it proved to be less promising
  when its use over one year was compared
  with the use of inhaled corticosteroids
                                                  (Simons, 1997)
Oral Theophylline
• Although there was no significant difference between
  theophylline and inhaled corticosteroids in reduction
  of asthma symptoms
   – There was an increased use of short-acting beta2 agonists
     and oral corticosteroids in children receiving theophylline

        In summary, its use in children cannot be
   recommended because of the potential for serious
      side effects, such as cardiac arrhythmias or
       convulsions, if therapeutic blood levels are
                        exceeded.
                                                       (Simons, 1997)
Immunotherapy
• Can be used as an adjunct to standard
  drug therapy in allergic asthmatic
  children
• Sublingual (allergy drops) and
  injectable (allergy shots) therapies
  – have been shown to reduce the presence
    of asthma and the overall use of asthma
    medication
                                     (Pifferi, 2002)
Immunotherapy
• Standard immunotherapy has a 1.7 to
  15 % reported range of adverse effects
  – between 1985 and 1989, there were 17
    standard immunotherapy-related deaths
    reported in the United States
Usual Dosages for Medications Used in the Long-Term
Control of Asthma in Children (part 1)

Medication                                                      Dosage form                                                      Dosage*


Long-acting inhaled beta2 agonists†
Formoterol (Foradil Aerolizer)                                  DPI: 12 mcg per single-use capsule                               1 capsule every 12 hours
Salmeterol (Serevent)                                           MDI: 21 mcg per puff                                             1 to 2 puffs every 12 hours
                                                                DPI: 50 mcg per blister                                          1 blister every 12 hours
Combined medication
Fluticasone/salmeterol (Advair                                  DPI: 100, 250, or 500 mcg of                                     1 inhalation twice daily; dosage
Diskus)                                                         fluticasone with 50 mcg of                                       depends on severity of asthma
                                                                salmeterol
Cromolyn and nedocromil
Cromolyn (Intal)                                                MDI: 1 mg per puff                                               1 to 2 puffs 3 to 4 times daily
                                                                Nebulizer solution: 20 mg per                                    1 ampule 3 to 4 times daily
                                                                ampule
Nedocromil (Tilade)                                             MDI: 1.75 mg per puff                                            1 to 2 puffs 2 to 4 times daily


DPI = dry-powder inhaler; MDI = metered-dose inhaler.*-Dosages are for children 12 years or younger unless otherwise specified. †-Should not be used for symptom relief or
exacerbations. Use with an inhaled corticosteroid. ‡-Serum monitoring is important (serum concentration of 5 to 15 mcg per mL at steady state). Adapted from National Asthma
Education and Prevention Program. Expert panel report: guidelines for the diagnosis and management of asthma: update on selected topics, 2002. Bethesda, Md.: U.S. Department of Health and
Human Services, Public Health Service, National Institutes of Health, National Heart, Lung, and Blood Institute, 2003; NIH publication no. 02-5074:133-5.
Usual Dosages for Medications Used in the Long-Term
Control of Asthma in Children (part 2)
Medication                                                      Dosage form                                                      Dosage*
Leukotriene modifiers

Montelukast (Singulair)                                         4- or 5-mg chewable tablets, 4-mg                                Age 12 to 23 months: 4 mg oral
                                                                packet of oral granules, 10-mg                                   granules at bedtime
                                                                tablets                                                          Age 2 to 5 years: 4 mg at bedtime
                                                                                                                                 Age 6 to 14 years: 5 mg at bedtime
                                                                                                                                 Older than 14 years: 10 mg at
                                                                                                                                 bedtime
Zafirlukast (Accolate)                                          10- and 20-mg tablets                                            Age 7 to 11 years: 20 mg daily in
                                                                                                                                 divided
                                                                                                                                 doses (i.e., one 10-mg tablet twice
                                                                                                                                 daily)
                                                                                                                                 12 years and older: 20 mg twice
                                                                                                                                 daily
Methylxanthines‡

Theophylline                                                    Liquids, sustained-release tablets,                              Starting dosage is 10 mg per kg per
                                                                and capsules                                                     day
                                                                                                                                 Usual maximums:
                                                                                                                                 Age < 1 year: (0.2 x [age in weeks])
                                                                                                                                 + 5 = mg per kg per day
                                                                                                                                 Age >= 1 year: 16 mg per kg per
                                                                                                                                 day
DPI = dry-powder inhaler; MDI = metered-dose inhaler.*-Dosages are for children 12 years or younger unless otherwise specified. †-Should not be used for symptom relief or
exacerbations. Use with an inhaled corticosteroid. ‡-Serum monitoring is important (serum concentration of 5 to 15 mcg per mL at steady state). Adapted from National Asthma
Education and Prevention Program. Expert panel report: guidelines for the diagnosis and management of asthma: update on selected topics, 2002. Bethesda, Md.: U.S. Department of Health and
Human Services, Public Health Service, National Institutes of Health, National Heart, Lung, and Blood Institute, 2003; NIH publication no. 02-5074:133-5.
Estimated Comparative Daily Dosages of Inhaled
Corticosteroids in Children 12 Years and Younger
Agent                                            Low daily dose                                   Medium daily dose                                High daily dose
Beclomethasone CFC                               84 to 336 mcg                                    336 to 672 mcg                                   > 672 mcg
(Beclovent, Vanceril), 42
or 84 mcg per puff
Beclomethasone HFA, 40                           80 to 160 mcg                                    160 to 320 mcg                                   > 320 mcg
or 80 mcg per puff
Budesonide (Pulmicort)
DPI: 200 mcg per                                 100 to 200 mcg                                   200 to 400 mcg                                   > 400 mcg
inhalation
Nebulizer solution: 0.25 or                      0.5 mg                                           1.0 mg                                           2.0 mg
0.5 mg per ampule

Flunisolide (Aerobid), 250                       500 to 750 mcg                                   1,000 to 1,250 mcg                               > 1,250 mcg
mcg per puff
Fluticasone (Flovent)
MDI: 44, 110, or 220 mcg                         88 to 176 mcg                                    176 to 440 mcg                                   > 440 mcg
per puff
DPI: 50, 100, or 250 mcg                         100 to 200 mcg                                   200 to 400 mcg                                   > 400 mcg
per inhalation
Triamcinolone acetonide                          400 to 800 mcg                                   800 to 1,200 mcg                                 > 1,200 mcg
(Azmacort), 100 mcg per
puff
CFC = chlorofluorocarbon; HFA = hydrofluoroalkane; DPI = dry-powder inhaler; MDI = metered-dose inhaler. Adapted from National Asthma Education and Prevention Program. Expert panel report:
guidelines for the diagnosis and management of asthma: update on selected topics, 2002. Bethesda, Md.: U.S. Department of Health and Human Services, Public Health Service, National Institutes
Key Clinical Recommendations
A spacer with a metered-dose inhaler is as effective as a nebulizer for delivery of a
bronchodilator in the treatment of an acute asthma exacerbation and for the delivery
of chronic prophylactic medications.

Physicians should consider adding inhaled ipratropium bromide (Atrovent) with each
inhalation of a beta2 agonist, particularly in the treatment of a more severe asthma
exacerbation.
If possible, oral corticosteroids should be administered within 45 minutes of the onset
of symptoms in an acute asthma exacerbation.

Modest doses of an inhaled corticosteroid are more effective than inhaled long-acting
beta2 agonists, inhaled nedocromil (Tilade), and leukotriene inhibitors in improving
asthma symptoms and lung function in children with moderate persistent asthma and
are recommended as the first-line treatment.

Parents and caregivers of children with asthma, particularly those with moderate to
severe disease, should be taught to recognize and avoid triggers and to understand
the use of prescribed medications and inhalation devices, and the importance of
compliance and monitoring.

A = consistent, good-quality patient-oriented evidence; B = inconsistent or limited-quality patient-oriented evidence; C = consensus, disease-oriented evidence, usual practice, opinion, or case series.
Adapted from National Asthma Education and Prevention Program. Expert panel report: guidelines for the diagnosis and management of asthma: update on selected topics, 2002. Bethesda, Md.:
U.S. Department of Health and Human Services, Public Health Service, National Institutes of Health, National Heart, Lung, and Blood Institute, 2003. NIH publication no. 02-5074:135.
Let’s Review!
Management of severe persistent asthma
 might include:

A.   Long-acting beta2 agonist
B.   High dose inhaled corticosteroid
C.   Leukotriene modifier
D.   Anticholinergic inhaler
E.   All of the above

				
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