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NCT04631016 · ClinicalTrials.gov registry record · Phase 2
A Phase II, Randomized, Double-blind, Placebo-controlled Study to Assess MEDI3506 in Participants With COPD and Chronic Bronchitis
A Phase 2 study of Chronic Obstructive Pulmonary Disease (COPD) and Chronic Bronchitis, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 2
- Development phase
- 137
- Enrollment target
- 20
- Study locations
NCT04631016: Completed Phase 2 study of Chronic Obstructive Pulmonary Disease (COPD) and Chronic Bronchitis, sponsored by AstraZeneca.
NCT04631016 is a Phase 2 study of Chronic Obstructive Pulmonary Disease (COPD) and Chronic Bronchitis that has completed, run by AstraZeneca. The registered enrollment target is 137 participants, below the 647-participant average among 36 other Chronic Obstructive Pulmonary Disease (COPD) trials with a reported enrollment target (79% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04631016, a Phase 2 study of Chronic Obstructive Pulmonary Disease (COPD) and Chronic Bronchitis, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 137 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a research study to determine the efficacy and safety of investigational drug MEDI3506 for the treatment of adult participants with Chronic Obstructive Pulmonary Disease and Chronic Bronchitis.
Primary Outcome
The mean change from baseline in Pre-BD FEV1 at Week 12 (tozorakimab - placebo) estimated using a repeated measures mixed effects analysis of covariance measures was estimated. Data available from all visits up to and including Week 12, irrespective of whether the participant discontinued study drug or received reliever therapy was considered. FEV1 was measured by spirometry at clinic.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Tozorakimab
Study Locations (20)
Other
- Research Site - Nedlands
- Research Site - South Brisbane
- Research Site - Spearwood
- Research Site - Tarragindi
Florida
- Research Site - Kissimmee
- Research Site - Ormond Beach
- Research Site - Winter Park
South Carolina
- Research Site - North Charleston
- Research Site - Spartanburg
Alabama
- Research Site - Sheffield
California
- Research Site - Newport Beach
Delaware
- Research Site - Newark
Kentucky
- Research Site - Lakeside Park
Maryland
- Research Site - White Marsh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 137 participants |
| Start Date | 2020-12-14 |
| Est. Completion | 2023-11-13 |
| Phase | Phase 2 |
What the finished NCT04631016 record still lists
NCT04631016 is an interventional study that assigns participants to a tested intervention. The registered 137 participants enrollment target is mid-sized for trials with a published cap, below the 647-participant average among 36 other Chronic Obstructive Pulmonary Disease (COPD) trials with a reported enrollment target (79% lower).
The record links to 2 conditions, with Chronic Obstructive Pulmonary Disease (COPD) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04631016 names 20 study sites across 14 states, led by Other, Florida, South Carolina.
Frequently Asked Questions
What is clinical trial NCT04631016 about?
NCT04631016 is a clinical study titled "A Phase II, Randomized, Double-blind, Placebo-controlled Study to Assess MEDI3506 in Participants With COPD and Chronic Bronchitis". This is a research study to determine the efficacy and safety of investigational drug MEDI3506 for the treatment of adult participants with Chronic Obstructive Pulmonary Disease and Chronic Bronchitis.
What is the current status of trial NCT04631016?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 137 participants. The study started on 2020-12-14. Estimated completion is 2023-11-13.
What conditions does trial NCT04631016 study?
This clinical trial studies the following conditions: Chronic Obstructive Pulmonary Disease (COPD), Chronic Bronchitis.
What interventions are being tested in trial NCT04631016?
The interventions under investigation include: Placebo (OTHER), Tozorakimab (DRUG).
Who is sponsoring clinical trial NCT04631016?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04631016 being conducted?
This trial has 20 study locations across Alabama, California, Delaware, Florida, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Obstructive Pulmonary Disease (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 NCT04631016's enrollment target sits among peer trials
137 25th of 36 higher than 12 of 36 other Chronic Obstructive Pulmonary Disease (COPD) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Obstructive Pulmonary Disease (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.
Source ClinicalTrials.gov registry export · 2026-08-08
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