Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01879410 · ClinicalTrials.gov registry record · Phase 3
A Study to Compare the Efficacy and Safety of Umeclidinium/Vilanterol With Fluticasone Propionate/Salmeterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 700
- Enrollment target
NCT01879410: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT01879410 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 700 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01879410, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 700 participants
- Enrollment target
Study Summary
Umeclidinium/vilanterol (UMEC/VI) is a combination product under development that is used for the treatment of airflow obstruction in patients with COPD. Fluticasone propionate/salmeterol (FSC) is an approved drug that is already in use for the treatment of COPD. This is a multicenter, randomized, double-blind, double-dummy, parallel group study to evaluate the efficacy and safety of UMEC/VI 62.5/25 microgram \[mcg\] once daily administered via Novel Dry Powder Inhaler (NDPI) compared with fluticasone propionate /salmeterol (FSC) 250/50 mcg twice-daily when administered via ACCUHALER/DISKUS inhaler over a treatment period of 12 weeks in subjects with COPD. Eligible subjects will be equally randomized to UMEC/VI 62.5/25 mcg or FSC 250/50 mcg for 12 weeks. A safety follow-up assessment will be conducted approximately 7 days after the end of the study treatment.
Primary Outcome
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean was calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5 and 15 minutes and 1, 3, 6, 9, 12 hours (pre-evening dose), 13, 15, 18, 23, and 24 hours after the morning dose. Baseline is defined as the mean of the assessments made 30 and 5 minutes (min) pre-dose on treatment Day 1. Analysis was performed using an analysis of covariance model
Interventions
- DRUG UMEC/VI Inhalation Powder 62.5/25 mcg via NDPI
- DRUG FSC Inhalation Powder 250/50 mcg via ACCUHALER/DISKUS
- DRUG Placebo DISKUS
- DRUG Placebo NDPI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 700 participants |
| Start Date | 2013-06-13 |
| Est. Completion | 2014-01-09 |
| Phase | Phase 3 |
What the finished NCT01879410 record still lists
NCT01879410 is an interventional study that assigns participants to a tested intervention. The registered 700 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 4 interventions - of which UMEC/VI Inhalation Powder 62.5/25 mcg via NDPI is the first listed.
NCT01879410 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01879410 about?
NCT01879410 is a clinical study titled "A Study to Compare the Efficacy and Safety of Umeclidinium/Vilanterol With Fluticasone Propionate/Salmeterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD)". Umeclidinium/vilanterol (UMEC/VI) is a combination product under development that is used for the treatment of airflow obstruction in patients with COPD. Fluticasone propionate/salmeterol (FSC) is an approved drug that is already in use for the treatment of COPD. This is a multicenter, randomized, d...
What is the current status of trial NCT01879410?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 700 participants. The study started on 2013-06-13. Estimated completion is 2014-01-09.
What interventions are being tested in trial NCT01879410?
The interventions under investigation include: UMEC/VI Inhalation Powder 62.5/25 mcg via NDPI (DRUG), FSC Inhalation Powder 250/50 mcg via ACCUHALER/DISKUS (DRUG), Placebo DISKUS (DRUG), Placebo NDPI (DRUG).
Who is sponsoring clinical trial NCT01879410?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01879410's enrollment target sits among peer trials
700 506th of 2000 higher than 1,485 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
- NCT00900419 · 700 participants
Biomarkers in Patients With Respiratory Tract Dysplasia or Lung Cancer, Head and Neck Cancer, or Aerodigestive Tract Cancer and in Normal Volunteers
- NCT01804686 · 700 participants · Phase 3
A Long-term Extension Study of PCI-32765 (Ibrutinib)
- NCT02107989 · 700 participants
Noninvasive Pre-surgical Evaluation of Patients With Focal Epilepsy and Establishment of a Normative Imaging Database
- NCT02129543 · 700 participants
Immune Reconstitution in Stem Cell Transplant Recipients
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