Replication of the P04334 Asthma Trial in Healthcare Claims Data

NCT04892758 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 10288

Last updated 2023-07-27

No results posted yet for this study

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

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04892758 on ClinicalTrials.gov