Environmental Control as Add-on Therapy in Childhood Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Flovent Diskus; Home Environmental Intervention; Advair Diskus
Intervention description: Inhaled corticosteroids; Mouse, Cockroach, Furry pets, Dust mites, Smoking, air purifiers, laundered bedding; inhaled corticosteroids + long-acting beta agonist
Intervention MeSH terms: Fluticasone; Xhance; Fluticasone-Salmeterol Drug Combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 155.0
Sex: All
Minimum age: 5 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This study evaluates the effects of adding on an environmental home intervention to standard
      asthma medication management on controller medication requirements among children and
      adolescents with asthma. The investigators hypothesize that the addition of an
      individually-tailored, multi-faceted Environmental Control Strategy (ECS) to guidelines-based
      controller medication will result in less controller medication requirement and allergic
      inflammation than controller medication alone among urban asthmatic children.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have physician-diagnosed asthma at least 1 year prior to the baseline visit, or asthma
             symptoms for at least 1 year

          -  Meet criteria for current persistent asthma defined as either:

               1. On a long-term controller medication for asthma, or

               2. Meet National Asthma Education and Prevention Program (NAEPP) guideline
                  requirements for persistent disease:(46)

          -  Asthma symptoms 3 or more days per week over the past 2 weeks or

          -  Nocturnal asthma symptoms at least 3 times in the past month

          -  Have evidence of uncontrolled disease as defined by at least one of the following:

               1. One asthma-related unscheduled visit to an emergency department (ED), clinic or
                  urgent care facility in the previous 12 mo

               2. One asthma-related overnight hospitalization in the previous 12 mo

               3. One or more bursts of oral corticosteroids in the previous 12 mo

          -  Reside within a geographic area of the study site so that home visits are feasible.

          -  Have no plans to move within the upcoming 6 months

          -  Have insurance to cover prescription medications.

          -  Have a positive skin test (net wheal ≥2mm) to cat, dog, mouse, cockroach, or dust
             mites or have a positive cat, dog, mouse, German cockroach, or D. farinae-specific
             immunoglobulin E (IgE) test, as quantified using the ImmunoCAP system (≥0.35 kU/L)

        Exclusion Criteria:

          -  Lung disease, other than asthma, that requires daily medication

          -  Cardiovascular disease that requires daily medication, excluding hypertension

          -  Taking a beta-blocker

          -  Allergy to dairy

          -  On Xolair < 5 months

          -  On immunotherapy and has not reached maintenance dose

          -  Sleeping in another home 4 or more nights/week

          -  Active smoker defined as a positive urine screen for high levels of urine cotinine

          -  Unable to access areas of home necessary to conduct extermination