Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01957163 · ClinicalTrials.gov registry record · Phase 3
Study to Compare the Addition of Umeclidinium Bromide (UMEC) to Fluticasone Furoate (FF)/Vilanterol (VI), With Placebo Plus FF/VI in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 619
- Enrollment target
NCT01957163: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT01957163 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 619 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01957163, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 619 participants
- Enrollment target
Study Summary
After screening, subjects will enter a 4 week open-label run-in period with fluticasone furoate (FF)/vilanterol (VI) 100/25 mcg administered once daily via dry powder inhaler (DPI). Subjects will then be randomized to receive any one of the 3 treatments (umeclidinium bromide \[UMEC\] \[62.5 mcg\] administered once daily via a DPI; OR UMEC \[125 mcg\] administered once daily via a DPI; OR matching placebo administered once daily via a DPI), while continuing treatment with open label FF/VI 100/25 mcg during a 12-week treatment period. There will be a total of eight scheduled clinic visits at Pre-Screening (Visit0), Screening (Visit 1), blinded treatment Day 1(Visit2), 2(Visit3), 28 (Visit4), 56 (Visit5), 84 (Visit6) and 85 (Visit7). A follow-up phone contact will be conducted approximately 7 days after the last clinic visit. The total duration of subject participation in the study from Screening to Follow-up will be approximately 17 weeks.
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. Trough FEV1 on Day 85 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Day 84. Analysis was performed using a mixed model repeated measures (MMRM) with covariates of treatment, Baseline FEV1, smoking status, Day, treatment, Day by baseline interaction and Day by treatment interaction, Day being nominal. Baseline FEV1 is the mean of the two
Interventions
- DRUG Placebo
- DRUG FF
- DRUG UMEC
- DRUG VI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 619 participants |
| Start Date | 2013-10-01 |
| Est. Completion | 2014-04-01 |
| Phase | Phase 3 |
What the finished NCT01957163 record still lists
NCT01957163 is an interventional study that assigns participants to a tested intervention. The registered 619 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01957163 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01957163 about?
NCT01957163 is a clinical study titled "Study to Compare the Addition of Umeclidinium Bromide (UMEC) to Fluticasone Furoate (FF)/Vilanterol (VI), With Placebo Plus FF/VI in Subjects With Chronic Obstructive Pulmonary Disease (COPD)". After screening, subjects will enter a 4 week open-label run-in period with fluticasone furoate (FF)/vilanterol (VI) 100/25 mcg administered once daily via dry powder inhaler (DPI). Subjects will then be randomized to receive any one of the 3 treatments (umeclidinium bromide \[UMEC\] \[62.5 mcg\] ad...
What is the current status of trial NCT01957163?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 619 participants. The study started on 2013-10-01. Estimated completion is 2014-04-01.
What interventions are being tested in trial NCT01957163?
The interventions under investigation include: Placebo (DRUG), FF (DRUG), UMEC (DRUG), VI (DRUG).
Who is sponsoring clinical trial NCT01957163?
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 NCT01957163's enrollment target sits among peer trials
619 591st of 2000 higher than 1,410 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
- NCT02282969 · 620 participants
PCORI-CER-1306-03385 Lung Cancer Screening Decision Aid Development and Testing
- NCT02838836 · 620 participants
Tumor Cell and DNA Detection in the Blood, Urine and Bone Marrow of Patients With Solid Cancers
- NCT05538910 · 620 participants · NA
Defining Neurobiological Links Between Substance Use and Mental Illness
- NCT05822466 · 620 participants · NA
Virtual Tai ji Quan Exercise to Prevent Falls in Older Adults
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