Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03381573
The ClinicalTrials.gov registry entry for NCT03381573 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 135,856 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 820-participant average among 85 other COPD trials with a reported enrollment target (16468% higher). The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.
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 4 study locations spanning 2 distinct geographic areas - top geographies include 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.
-
Impact of Positive Airway Pressure Therapy on Clinical Outcomes in Older Veterans With Chronic Obstructive Pulmonary Disease and Comorbid Obstructive Sleep Apnea (Overlap Syndrome)
RECRUITING · NA
-
Evaluating the Safety and Efficacy of dNerva Lung Denervation System in Patients With COPD
RECRUITING · NA
-
Pulmonary Hypertension SOLAR
RECRUITING · Phase 2
-
Hyperpolarized 129Xe MR Imaging of Lung Function in Healthy Volunteers and Subjects With Pulmonary Disease
RECRUITING · Phase 1
-
Home Hospital for Suddenly Ill Adults
RECRUITING · NA
-
Relationship of Inflammation and Pulmonary Function to Fungal Translocation in HIV
RECRUITING
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.