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NCT02796677 · ClinicalTrials.gov registry record · Phase 3
AMPLIFY - D6571C00001 Duaklir USA Phase III Study
A Phase 3 study of Chronic Obstructive Pulmonary Disease, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,595
- Enrollment target
- 20
- Study locations
NCT02796677: Completed Phase 3 study of Chronic Obstructive Pulmonary Disease, sponsored by AstraZeneca.
NCT02796677 is a Phase 3 study of Chronic Obstructive Pulmonary Disease that has completed, run by AstraZeneca. The registered enrollment target is 1,595 participants, roughly in line with the 1,735-participant average among 86 other Chronic Obstructive Pulmonary Disease trials with a reported enrollment target. The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02796677, a Phase 3 study of Chronic Obstructive Pulmonary Disease, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,595 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a multiple dose, randomized, parallel, double-blind, double-dummy, multicenter and multinational Phase III study to determine the efficacy and safety of Aclidinium bromide 400μg/Formoterol Fumarate (AB/FF) 12 μg compared to individual components and TIO (Tiotropium) 18 μg when administered to patients with stable chronic obstructive pulmonary disease (COPD).
Primary Outcome
To assess the bronchodilatory effect by evaluating the mean changes from baseline in FEV1 at 1 hour post-dose of AB/FF 400/12 µg compared to AB 400 μg after administration of oral inhalation powder BID via DIP to participants with COPD. Baseline was defined as the average of the two FEV1 values measured just prior to the administration of the first dose of investigational product (IP) at randomization Visit. If one of the two was missing, then the available one would be used as baseline value.
Conditions Studied
Interventions
- DRUG Aclidinium bromide 400 μg/Formoterol Fumarate 12 μg (AB/FF 400/12 μg)
- DRUG Aclidinium bromide 400 μg (AB 400 μg)
- DRUG Formoterol fumarate 12 μg (FF 12 μg)
- OTHER Placebo to AB/FF 400/12 μg, AB 400 μg and FF 12 μg
- DRUG Tiotropium 18 μg (TIO 18 μg)
Study Locations (20)
Florida
- Research Site - Clearwater
- Research Site - Edgewater
- Research Site - Hollywood
- Research Site - Homestead
- Research Site - Miami
- Research Site - Miami
- Research Site - Miami Lakes
- Research Site - Ormond Beach
- Research Site - Port Orange
- Research Site - Sarasota
- Research Site - St. Petersburg
California
- Research Site - Corona
- Research Site - Fresno
- Research Site - Fullerton
- Research Site - Lincoln
- Research Site - San Diego
Arizona
- Research Site - Phoenix
- Research Site - Tucson
Alabama
- Research Site - Gulf Shores
Connecticut
- Research Site - Waterbury
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,595 participants |
| Start Date | 2016-07-05 |
| Est. Completion | 2017-06-08 |
| Phase | Phase 3 |
What the finished NCT02796677 record still lists
NCT02796677 is an interventional study that assigns participants to a tested intervention. Its 1,595 participants enrollment target places it among the larger protocols in the corpus, roughly in line with the 1,735-participant average among 86 other Chronic Obstructive Pulmonary Disease trials with a reported enrollment target.
The record links to 1 condition, with Chronic Obstructive Pulmonary Disease appearing as the primary indexed condition, and to 5 interventions - of which Aclidinium bromide 400 μg/Formoterol Fumarate 12 μg (AB/FF 400/12 μg) is the first listed.
NCT02796677 names 20 study sites across 5 states, led by Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT02796677 about?
NCT02796677 is a clinical study titled "AMPLIFY - D6571C00001 Duaklir USA Phase III Study". This is a multiple dose, randomized, parallel, double-blind, double-dummy, multicenter and multinational Phase III study to determine the efficacy and safety of Aclidinium bromide 400μg/Formoterol Fumarate (AB/FF) 12 μg compared to individual components and TIO (Tiotropium) 18 μg when administered t...
What is the current status of trial NCT02796677?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,595 participants. The study started on 2016-07-05. Estimated completion is 2017-06-08.
What conditions does trial NCT02796677 study?
This clinical trial studies the following conditions: Chronic Obstructive Pulmonary Disease.
What interventions are being tested in trial NCT02796677?
The interventions under investigation include: Aclidinium bromide 400 μg/Formoterol Fumarate 12 μg (AB/FF 400/12 μg) (DRUG), Aclidinium bromide 400 μg (AB 400 μg) (DRUG), Formoterol fumarate 12 μg (FF 12 μg) (DRUG), Placebo to AB/FF 400/12 μg, AB 400 μg and FF 12 μg (OTHER), Tiotropium 18 μg (TIO 18 μg) (DRUG).
Who is sponsoring clinical trial NCT02796677?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02796677 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02796677's enrollment target sits among peer trials
1,595 10th of 86 higher than 77 of 86 other Chronic Obstructive Pulmonary Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Obstructive Pulmonary Disease 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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