Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03162055 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Glycopyrronium/Formoterol Fumarate Fixed-dose Combination Relative to Umeclidinium/Vilanterol Fixed-dose Combination Over 24 Weeks in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
A Phase 3 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,119
- Enrollment target
NCT03162055: Completed Phase 3 study, sponsored by AstraZeneca.
NCT03162055 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 1,119 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (45% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03162055, a Phase 3 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,119 participants
- Enrollment target
Study Summary
This is a phase IIIb randomised, double-blind, double-dummy, multicentre, parallel group, 24 week study to assess the efficacy and safety of Glycopyrronium/Formoterol Fumarate (GFF) fixed-dose combination 7.2/4.8 μg 2 inhalations twice daily compared to Umeclidinium/Vilanterol (UV) 62.5/25 μg fixed-dose combination 1 inhalation once daily in Patients with moderate to very severe COPD.
Primary Outcome
To assess the effects of GFF relative to UV on lung function as measured by change from baseline in morning pre-dose trough FEV1 is defined as the average of the -60 and -30 minute pre-dose values at each visit minus baseline using spirometry. Baseline is defined as the mean of the non-missing -60 and -30 minute values obtained prior to dosing at randomization (Day 1). BR a/s = bronchodilator responsiveness to albuterol/salbutamol.
Interventions
- DRUG Glycopyrronium/Formoterol Fumarate
- DRUG umeclidinium/vilanterol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,119 participants |
| Start Date | 2017-05-25 |
| Est. Completion | 2018-05-04 |
| Phase | Phase 3 |
What the finished NCT03162055 record still lists
NCT03162055 is an interventional study that assigns participants to a tested intervention. Its 1,119 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (45% higher).
The record links to 0 conditions, and to 2 interventions - of which Glycopyrronium/Formoterol Fumarate is the first listed.
NCT03162055 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03162055 about?
NCT03162055 is a clinical study titled "Efficacy and Safety of Glycopyrronium/Formoterol Fumarate Fixed-dose Combination Relative to Umeclidinium/Vilanterol Fixed-dose Combination Over 24 Weeks in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease". This is a phase IIIb randomised, double-blind, double-dummy, multicentre, parallel group, 24 week study to assess the efficacy and safety of Glycopyrronium/Formoterol Fumarate (GFF) fixed-dose combination 7.2/4.8 μg 2 inhalations twice daily compared to Umeclidinium/Vilanterol (UV) 62.5/25 μg fixed-...
What is the current status of trial NCT03162055?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,119 participants. The study started on 2017-05-25. Estimated completion is 2018-05-04.
What interventions are being tested in trial NCT03162055?
The interventions under investigation include: Glycopyrronium/Formoterol Fumarate (DRUG), umeclidinium/vilanterol (DRUG).
Who is sponsoring clinical trial NCT03162055?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03162055's enrollment target sits among peer trials
1,119 249th of 2000 higher than 1,752 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02140255 · 1,120 participants · Phase 1
Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission
- NCT06618534 · 1,120 participants · Phase 2
Azithromycin for Meningococcal Carriage
- NCT07164131 · 1,120 participants · Phase 4
Azithromycin Versus Doxycycline in Hospitalized Adult Patients With Community Acquired Pneumonia Treated With Beta-lactams
- NCT05691478 · 1,122 participants · Phase 2
A Study to Test the Addition of the Drug Cabozantinib to Chemotherapy in Patients With Newly Diagnosed Osteosarcoma
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI