Environmental Control as Add-on Therapy in Childhood Asthma

• Status: Completed
• Trial end date: 2018-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Treatments: Fluticasone; Fluticasone Propionate, Salmeterol Xinafoate Drug Combination; Fluticasone-Salmeterol Drug Combination; Xhance

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