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A Study to Assess the Efficacy of Fluticasone Furoate/Vilanterol (FF/VI) Inhalation Powder 100/25 mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inhalation Powder 250/50 mcg Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
NCT01706328 · View on ClinicalTrials.gov ↗
Study Summary
This will be a Phase IIIb multicentre, randomized, double-blind, double-dummy, 12-week parallel group study evaluating the effects of once daily in the morning treatment of FF/VI Inhalation Powder versus Fluticasone Propionate/Salmeterol Inhalation Powder twice daily on lung function in COPD subjects. Subjects will be screened and will enter a 2-week, single-blind (placebo), Run-In Period to evaluate the subject's adherence with study treatment, study procedures and assessment of disease stability. At the end of the Run-In Period, subjects will return to the Clinic and who meet all of the Randomization Criteria will be randomized to double-blind study medication (12-week treatment period). Subjects will be randomized to receive either FF/VI 100/25 via NDPI or Fluticasone Propionate/Salmeterol 250/50mcg via ACCUHALER/DISKUS. Matching placebos will be available in NDPI and ACCUHALER/DISKUS. Each morning (approximately 6-10 AM) subjects will take 1 inhalation from the NDPI followed by 1 inhalation from the ACCUHALER/DISKUS. Each evening (approximately 6-10 PM), approximately 12 hours after the morning dose with blinded study medication, subjects will take 1 inhalation from the ACCUHALER/DISKUS. Subjects will return to the clinic at the end of the treatment period. A follow-up phone contact will be performed approximately 7 days after the last clinic visit. The overall study duration (Screening to Follow-up) for each subject is approximately 15 weeks.
Conditions Studied
Interventions
- DRUG Salbutamol as needed
- DRUG FF/VI 100/25 Inhalation Powder NDPI
- DRUG Fluticasone Propionate/Salmeterol 250/50 Inhalation Powder ACCUHALER/DISKUS
- DRUG Placebo Inhalation Powder NDPI
- DRUG Placebo Inhalation Powder ACCUHALER/DISKUS
Study Locations (20)
South Carolina
- GSK Investigational Site — Easley
- GSK Investigational Site — Gaffney
- GSK Investigational Site — Greenville
- GSK Investigational Site — Orangeburg
- GSK Investigational Site — Rock Hill
- GSK Investigational Site — Seneca
- GSK Investigational Site — Spartanburg
- GSK Investigational Site — Union
Hesse
- GSK Investigational Site — Frankfurt am Main
- GSK Investigational Site — Frankfurt am Main
- GSK Investigational Site — Neu-Isenburg
Florida
- GSK Investigational Site — Clearwater
- GSK Investigational Site — DeLand
Idaho
- GSK Investigational Site — Coeur d'Alene
Illinois
- GSK Investigational Site — Normal
Minnesota
- GSK Investigational Site — Woodbury
North Carolina
- GSK Investigational Site — Charlotte
Ohio
- GSK Investigational Site — Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 828 participants |
| Start Date | 2012-10-15 |
| Est. Completion | 2013-06-17 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01706328
The ClinicalTrials.gov registry entry for NCT01706328 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 828 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 558 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Pulmonary Disease, Chronic Obstructive appearing as the primary indexed condition, and to 5 interventions — of which Salbutamol as needed is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01706328 reports 20 study locations spanning 10 distinct geographic areas — top geographies include South Carolina, Hesse, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01706328 about?
NCT01706328 is a clinical study titled "A Study to Assess the Efficacy of Fluticasone Furoate/Vilanterol (FF/VI) Inhalation Powder 100/25 mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inhalation Powder 250/50 mcg Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)". This will be a Phase IIIb multicentre, randomized, double-blind, double-dummy, 12-week parallel group study evaluating the effects of once daily in the morning treatment of FF/VI Inhalation Powder versus Fluticasone Propionate/Salmeterol Inhalation Powder twice daily on lung function in COPD subject...
What is the current status of trial NCT01706328?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 828 participants. The study started on 2012-10-15. Estimated completion is 2013-06-17.
What conditions does trial NCT01706328 study?
This clinical trial studies the following conditions: Pulmonary Disease, Chronic Obstructive. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01706328?
The interventions under investigation include: Salbutamol as needed (DRUG), FF/VI 100/25 Inhalation Powder NDPI (DRUG), Fluticasone Propionate/Salmeterol 250/50 Inhalation Powder ACCUHALER/DISKUS (DRUG), Placebo Inhalation Powder NDPI (DRUG), Placebo Inhalation Powder ACCUHALER/DISKUS (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01706328?
This trial is sponsored by GlaxoSmithKline, which has 558 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01706328 being conducted?
This trial has 20 study locations across Florida, Idaho, Illinois, Minnesota, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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