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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Page 1 of 1 (1 locations)

1

National Jewish Health

Denver, Colorado, United States, 80206