Status:
UNKNOWN
Creation of Home-based Asthma Real-World Measures With Mobile Health Study
Lead Sponsor:
National Jewish Health
Conditions:
Asthma
Eligibility:
All Genders
18-85 years
Brief Summary
Four novel biologic therapies (benralizumab, dupilumab, mepolizumab, reslizumab) have been recently approved for moderate-to-severe, eosinophilic or oral steroid-dependent asthma. The efficacy and saf...
Eligibility Criteria
Inclusion
- A diagnosis of uncontrolled or difficult-to-treat asthma, defined as 1 course of systemic corticosteroids (e.g. oral prednisone) in the last 12 months
- OR -
- An asthma control test (ACT) score less than or equal to 19 despite regular use of inhaled corticosteroids (ICS) therapy (at least 176 mcg of fluticasone/day or the equivalent)
- Participants will need access to a smartphone (As of January 2018, \~ 80% of U.S. adults owned a smartphone (Mobile Fact Sheet, 2018))
Exclusion
- Active smoking
- Any significant comorbid conditions that could inadvertently interfere with study results (i.e. any terminal illness, cancer, HIV, end-stage renal disease, congestive heart failure, severe autoimmune disease or inflammatory bowel disease)
- Conditions that require bursts of oral corticosteroids
- Other significant lung diseases (cystic fibrosis, pulmonary hypertension, interstitial lung disease, pulmonary fibrosis among others) to be determined by the investigators.
Key Trial Info
Start Date :
January 11 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2023
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04462224
Start Date
January 11 2021
End Date
July 1 2023
Last Update
June 23 2021
Active Locations (1)
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1
National Jewish Health
Denver, Colorado, United States, 80206