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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 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 700 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01879410
The ClinicalTrials.gov registry entry for NCT01879410 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 700 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 UMEC/VI Inhalation Powder 62.5/25 mcg via NDPI is the first listed.
NCT01879410 reports 0 study locations.
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.
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