Status:
UNKNOWN
Measuring Omalizumab Responses Using Real-world Evidence (MORRE) Study
Lead Sponsor:
National Jewish Health
Conditions:
Asthma
Eligibility:
All Genders
18-85 years
Brief Summary
Develop new real-world evidence indicators of worsening and improving asthma. Scientists will measure (1) steps per day, (2) duration and intensity of exercise per day, (3) sleep duration and the numb...
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) for at least 1 month prior to enrollment.
- Participants will need access to a smartphone.
Exclusion
- Active smoking and any significant comorbid conditions that could inadvertently interfere with study results as determined by the study investigators (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)
- Other disease that may mimic asthma, including vocal cord dysfunction, hypersensitivity pneumonitis, or tracheobronchomalacia.
Key Trial Info
Start Date :
February 5 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 15 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04724278
Start Date
February 5 2021
End Date
July 15 2023
Last Update
June 23 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Jewish Health
Denver, Colorado, United States, 80206