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 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 619 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01957163
The ClinicalTrials.gov registry entry for NCT01957163 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 619 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01957163 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.