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NCT01706328 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study of Pulmonary Disease, Chronic Obstructive, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 828
- Enrollment target
- 20
- Study locations
NCT01706328: Completed Phase 3 study of Pulmonary Disease, Chronic Obstructive, sponsored by GlaxoSmithKline.
NCT01706328 is a Phase 3 study of Pulmonary Disease, Chronic Obstructive that has completed, run by GlaxoSmithKline. The registered enrollment target is 828 participants, below the 1,033-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (20% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01706328, a Phase 3 study of Pulmonary Disease, Chronic Obstructive, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 828 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
FEV1 is a measure of lung function and is defined as the volume of air that can be forcefully exhaled in one second. The weighted mean was calculated from the pre-dose FEV1 and the post-dose FEV1 measurements taken at 5, 15, 30, and 60 minutes and 2, 4, 6, 8, 12, 13, 14, 16, 20, and 24 hours on Treatment Day 84. Baseline trough FEV1 was calculated as the mean of the two assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1. The weighted mean was derived by calculating th
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 |
What the finished NCT01706328 record still lists
NCT01706328 is an interventional study that assigns participants to a tested intervention. The registered 828 participants enrollment target is mid-sized for trials with a published cap, below the 1,033-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (20% lower).
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.
NCT01706328 names 20 study sites across 10 states, led by South Carolina, Hesse, Florida.
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.
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).
Who is sponsoring clinical trial NCT01706328?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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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828 19th of 74 higher than 56 of 74 other Pulmonary Disease, Chronic Obstructive trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pulmonary Disease, Chronic Obstructive 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.
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