Environmental Control as Add-on Therapy in Childhood Asthma

Phase 2

Completed

Interventions: Drug: Flovent Diskus
Other: Home Environmental Intervention
Drug: Advair Diskus

Brief 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.

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
ECS + Medication Group	Flovent Diskus	The Environmental Control Strategy ("Home Environmental Intervention") plus inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus)
ECS + Medication Group	Advair Diskus	The Environmental Control Strategy ("Home Environmental Intervention") plus inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus)
Medication Group Alone	Flovent Diskus	inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus)
Medication Group Alone	Advair Diskus	inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus)
ECS + Medication Group	Home Environmental Intervention	The Environmental Control Strategy ("Home Environmental Intervention") plus inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus)

Primary Outcome Measures

Name	Time	Method
The Medication Treatment Step Assigned	6 month clinic visit	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.

Secondary Outcome Measures

Name	Time	Method
Daily Inhaled Corticosteroid Dose	6 months	micrograms of inhaled corticosteroids (daily)
Number of Asthma Symptom Days	6 months	Number of asthma symptom days in the past two weeks will be a measure of asthma control.
Number of Asthma Exacerbations	6 months	Asthma exacerbations will be assessed by number of acute visits to the emergency department (ED), hospitalizations and urgent doctor visits.
Exhaled Nitric Oxide	6 months	Exhaled nitric oxide in parts per billion.
FEV1/FVC	6 months	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.