Comparative Effectiveness of Environmental Intervention and Standard Care in Ability to Reduce Pharmacologic Therapy for Asthma
Comparative Effectiveness of Environmental Intervention and Standard Care in Ability to Reduce Pharmacologic Therapy for Asthma
Exposure to household allergens is a major contributor to asthma symptoms. Aggressive
 measures to reduce household allergens has the potential to reduce asthma symptoms and the
 need for medications to control asthma. The investigators plan to enroll patients aged 6 and
 above into a single blind, randomized study comparing intensive environmental intervention
 with usual asthma care over a 48 week study period. All subjects will have asthma treatment
 optimized according to guideline based care. Subjects will be randomized to an aggressive
 environmental remediation arm versus distribution of written materials regarding allergen
 reduction ("usual care"). Primary outcome measure will be ability to reduce asthma step
 therapy. Secondary outcomes include measures of lung function, asthma biomarkers and quality
 of life.
Research question(s):

 In individuals with atopic asthma who are being treated with inhaled corticosteroids with or
 without long acting beta agonists (1 of 6 possible steps of treatment), aggressive
 environmental intervention to reduce exposure to home allergens is more likely to lead to one
 step reduction in asthma controller therapy, improved asthma control and improved biomarkers
 of airway inflammation than is usual care.

 Scientific abstract:

 Environmental exposure to indoor allergens is a major contributor to asthma impairment and
 risk, particularly among asthmatic patients residing in inner cities. The investigators plan
 a randomized controlled trial to assess the effect of individualized, comprehensive,
 multifaceted indoor allergen avoidance measures on ability to step down asthma controller
 therapy in adults and children greater than 6 years with mild to severe persistent asthma.

 Specifically,

 1. To determine via a randomized, controlled trial in allergen sensitized asthma patients
 whether environmental intervention aimed at reducing exposure to indoor allergens and
 irritants is more effective in reducing National Asthma Education and Prevention Program
 (NAEPP) step based therapy than usual care over a 48 week study period.

 2a. To determine if environmental intervention leads to reduction in indoor allergen levels,
 allergen specific serum IgE levels, airway hyper-responsiveness, fractional excretion of
 nitric oxide, asthma symptom score, asthma exacerbations, treatment failures and improved
 lung function compared to usual care over a 48 week study period.

 2b. (Exploratory): To determine if there is an association between reduction in allergen
 specific IgE level and reduction in NAEPP step level required for asthma control among
 subjects randomized to environmental intervention compared with usual care.
Inclusion Criteria:

 -  Clinical history consistent with asthma in male and female subjects ages 6 and above.

 -  Need for controller therapy demonstrated by current use of a stable dose (at least 4
 weeks) of long term asthma controller therapy; or if not receiving long term asthma
 controller, symptoms consistent with persistent asthma (eg. Symptoms > 3x per week).

 -  Prebronchodilator FEV1 > 40% predicted at screening (V0)

 -  Positive skin test (defined as wheal greater than 3 mm in diameter greater than saline
 negative control) to protein extracts of at least one of 9 common indoor allergens
 including dust mites, cockroach mix, rat, mouse, Alternaria, Cladosporium,
 Aspergillus, cat and dog tested at Visit 0 (or positive RAST test to at least on
 aeroallergen if FEV1<60% at Visit 0 precluding allergen skin testing.)

 -  Evidence of at least one allergen in household dust which matches skin test positivity
 or RAST testing (overlap to be checked and recorded at V3).

 -  Asthma confirmed by either reversibility to 4 puffs albuterol greater than or equal to
 12% in FEV1 at V0 OR PC20 FEV1 methacholine of less than or equal 16 mg/ml at or up to
 30 days previous to V1.

 -  Sleeps overnight at same address at least 5 times per week.

 Exclusion Criteria:

 -  Significant medical illness other than asthma including other chronic respiratory
 illness (eg emphysema, cystic fibrosis)

 -  Currently receiving immunotherapy or received such therapy in the past year

 -  Emergency Department (ED) visit for asthma or steroid taper within the past 2 weeks
 (may be rescreened at a future date).

 -  Investigational drug within the past 30 days; anti-IgE therapy within past 6 months

 -  Active smoker or greater than 10 pack year history of asthma

 -  Asthma requiring mechanical ventilation within the past 5 years

 -  Significant occupational exposures as determined by principal investigator.