Status:
COMPLETED
Environmental Control as Add-on Therapy in Childhood Asthma
Lead Sponsor:
Johns Hopkins University
Conditions:
Asthma
Eligibility:
All Genders
5-17 years
Phase:
PHASE2
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 asth...
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 stab...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2018
Estimated Enrollment :
155 Patients enrolled
Trial Details
Trial ID
NCT02251379
Start Date
October 1 2014
End Date
November 1 2018
Last Update
November 20 2019
Active Locations (1)
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1
Johns Hopkins University
Baltimore, Maryland, United States, 21287