Environmental Control as Add-on Therapy in Childhood Asthma

Study Overview
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Brief Summary
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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.

Detailed Description
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The study is a parallel arm study of an individually tailored, multi-faceted ECS plus controller medication titration versus controller medication titration alone. After a 4-week run-in period to stabilize the asthma, the investigators will randomize 200 Baltimore children with persistent asthma and a recent exacerbation in a 1:1 ratio to the two arms and follow the children for six months. There will be five clinic visits and three home visits over this time period for clinical and home assessments, respectively. There will be up to four environmental intervention visits for participants randomized to the environmental control plus controller medication group. The environmental modules include mouse, cockroach, furry pets, dust mites, and smoking. Air purifiers and laundered bedding are also included in this arm. Participants randomized to the controller medication group have the option of having one home visit after completing the study at which the participants will receive home intervention services that the environmental control plus controller medication group received. Participants will have repeated assessment of: controller medication requirements; secondary clinical, physiologic, and inflammatory outcomes; and particulate matter (PM), air nicotine, and allergen levels.

Official Title
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Environmental Control as Add-on Therapy in Childhood Asthma

Conditions
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Asthma

Intervention / Treatment
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* Drug: Flovent Diskus
* Other: Home Environmental Intervention
* Drug: Advair Diskus


Participation Criteria
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Eligibility Criteria
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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: On a long-term controller medication for asthma, or 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: One asthma-related unscheduled visit to an emergency department (ED), clinic or urgent care facility in the previous 12 mo One asthma-related overnight hospitalization in the previous 12 mo 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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ECS + Medication Group<br>The Environmental Control Strategy (Home Environmental Intervention) plus inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus) | Drug: Flovent Diskus<br>* Inhaled corticosteroids<br>* Other names: Flovent Diskus, 50 mcg, 100mcg, 250 mcg;Other: Home Environmental Intervention<br>* Mouse, Cockroach, Furry pets, Dust mites, Smoking, air purifiers, laundered bedding<br>Drug: Advair Diskus<br>* inhaled corticosteroids + long-acting beta agonist<br>|
| Active Comparator: Medication Group Alone<br>inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus) | Drug: Flovent Diskus<br>* Inhaled corticosteroids<br>* Other names: Flovent Diskus, 50 mcg, 100mcg, 250 mcg;Drug: Advair Diskus<br>* inhaled corticosteroids + long-acting beta agonist<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Medication Treatment Step Assigned | The controller medication treatment step that was assigned at the visit, which is based on the current controller medication treatment step and the current level of asthma control. The range is from 0-6, with 0 indicating no controller medication and 6 indicating high dose inhaled corticosteroids plus long-acting beta agonist. | 6 month clinic visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily Inhaled Corticosteroid Dose | micrograms of inhaled corticosteroids (daily) | 6 months | 
| Exhaled Nitric Oxide | Exhaled nitric oxide in parts per billion. | 6 months | 
| Number of Asthma Symptom Days | Number of asthma symptom days in the past two weeks will be a measure of asthma control. | 6 months | 
| Number of Asthma Exacerbations | Asthma exacerbations will be assessed by number of acute visits to the emergency department (ED), hospitalizations and urgent doctor visits. | 6 months | 
| FEV1/FVC | Forced expiratory volume at one second/forced vital capacity (FEV1/FVC) will be evaluated as a continuous variable. This is a ratio without any units. | 6 months |