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NCT03381573 · ClinicalTrials.gov registry record
Long-term Observational Study of the Safety of Roflumilast
A clinical trial of COPD, sponsored by AstraZeneca.
- Completed
- Registry status
- 135,856
- Enrollment target
- 4
- Study locations
NCT03381573: Completed study of COPD, sponsored by AstraZeneca.
NCT03381573 is a study of COPD that has completed, run by AstraZeneca. The registered enrollment target is 135,856 participants, above the 820-participant average among 85 other COPD trials with a reported enrollment target (16468% higher). The trial reports 4 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03381573, a study of COPD, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- 135,856 participants
- Enrollment target
- 4
- Study locations
Study Summary
This is a retrospective cohort study comparing COPD patients aged 40 years and older with new exposure to roflumilast with up to 5 unexposed (ie, not roflumilast-exposed) COPD controls matched by propensity score (PS), age, sex, and year of cohort entry. The study is using electronic healthcare databases in the US (Military Health System database), Germany (GER) (German Pharmacoepidemiological Research Database), and Sweden (SWE) (national databases including healthcare, death, and demographics data). The main objective of this study is to evaluate the long-term safety of roflumilast in the treatment of COPD with main focus on the primary outcome of all-cause mortality and evaluation of potential safety issues identified during the clinical trials of roflumilast. Crude mortality and incidence rates will be compared between roflumilast exposed and unexposed COPD patients and adjusted hazard ratios (HRs) of the primary and secondary outcomes will be calculated.
Primary Outcome
Safety objective to estimate 5-year all-cause mortality
Conditions Studied
Interventions
- DRUG Roflumilast
Study Locations (4)
Other
- Research Site - Bremen
- Research Site - Oslo
- Research Site - Solna
Massachusetts
- Research Site - Cambridge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 135,856 participants |
| Start Date | 2013-12-15 |
| Est. Completion | 2022-09-16 |
What the finished NCT03381573 record still lists
NCT03381573 is an observational study that tracks outcomes without assigning an intervention. Its 135,856 participants enrollment target places it among the larger protocols in the corpus, above the 820-participant average among 85 other COPD trials with a reported enrollment target (16468% higher).
The record links to 1 condition, with COPD appearing as the primary indexed condition, and to 1 intervention - of which Roflumilast is the first listed.
NCT03381573 reports a single indexed study location in Other, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03381573 about?
NCT03381573 is a clinical study titled "Long-term Observational Study of the Safety of Roflumilast". This is a retrospective cohort study comparing COPD patients aged 40 years and older with new exposure to roflumilast with up to 5 unexposed (ie, not roflumilast-exposed) COPD controls matched by propensity score (PS), age, sex, and year of cohort entry. The study is using electronic healthcare data...
What is the current status of trial NCT03381573?
This trial is currently completed. The enrollment target is 135,856 participants. The study started on 2013-12-15. Estimated completion is 2022-09-16.
What conditions does trial NCT03381573 study?
This clinical trial studies the following conditions: COPD.
What interventions are being tested in trial NCT03381573?
The interventions under investigation include: Roflumilast (DRUG).
Who is sponsoring clinical trial NCT03381573?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03381573 being conducted?
This trial has 4 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for COPD
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03381573's enrollment target sits among peer trials
135,856 1st of 85 higher than 85 of 85 other COPD trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other COPD trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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