Replication of the P04334 Asthma Trial in Healthcare Claims Data
NCT04892758 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 10288
Last updated 2023-07-27
Summary
Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.
Conditions
Interventions
- DRUG
-
Formoterol fumarate 10 mcg
Formoterol fumarate 10 mcg dispensing claim is used as the reference group.
- DRUG
-
Mometasone furoate/formoterol fumarate combination MDI 200/10 mcg BID
Mometasone furoate/formoterol fumarate combination MDI 200/10 mcg BID dispensing claim is used as the exposure group.
Sponsors & Collaborators
-
Brigham and Women's Hospital
lead OTHER
Principal Investigators
-
Shirley Wang, PhD, ScM · Brigham and Women's Hospital
Eligibility
- Min Age
- 12 Years
- Max Age
- 120 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-10-29
- Primary Completion
- 2021-06-11
- Completion
- 2021-06-11
- FDA Drug
- Yes
Countries
- United States
Study Locations
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