Trial · NCT02105974
Study Evaluating the Efficacy and Safety of Fluticasone Furoate/Vilanterol Inhalation Powder (FF/VI) Compared With Vilanterol Inhalation Powder (VI) in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
NCT02105974, Phase 3, Completed, GlaxoSmithKline; results first posted 2016-04-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study Evaluating the Efficacy and Safety of Fluticasone Furoate/Vilanterol Inhalation Powder (FF/VI) Compared With Vilanterol Inhalation Powder (VI) in Subjects With Chronic Obstructive Pulmonary Disease (COPD). Trials, record NCT02105974. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02105974
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Study Evaluating the Efficacy and Safety of Fluticasone Furoate/Vilanterol Inhalation Powder (FF/VI) Compared With Vilanterol Inhalation Powder (VI) in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
- NCT number
- NCT02105974
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,621 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- Fluticasone Furoate/Vilanterol, Vilanterol
- First posted
- 2014-04-07
- Last updated
- 2018-01-24
- Results first posted
- 2016-04-13
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline (BL) in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) FEV1, on Treatment Day 84 | Baseline to Day 84 | Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 14, 28, 56 and 84. BL was defined as the mean of the assessments made 30 minutes pre-dose and immediately pre-dose on Treatment Day 1.Trough FEV1 was defined as the mean of the FEV1 values obtained 23 and 24 hours after previous morning's dosing. Change from BL was calculated as the average at each visit minus the BL value. Analysis was performed using a repeated measures model with covariates of treatment, reversibility status (stratum), BL, region, day, day by BL and day by treatment interactions. |
| Secondary | Percentage of Rescue-free 24-hour Periods Over the Entire 12-week Treatment Period | BL (Week -1), Week 1 to Week 12 | Participants were given daily record cards for daily completion from BL (Week -1) through Week 12 (Visit 7) each morning and prior prior to taking study medication (i.e., single-blind and double-blind study medication), supplemental medication (albuterol \[salbutamol\] if received). Participants recorded number of occasions supplemental albuterol/salbutamol (MDI and/or nebules) or oxitropium bromide (applicable sites in Japan) used over the previous 24 hours and any medical problems that they had experienced and any medication used to treat these medical problems over the previous 24 hours. Rescue-free 24-hour periods are defined as the 24-hour periods in which the rescue medication (albuterol \[salbutamol\]) was not used. The percentage of 24-hour periods are summarized for the entire treatment period (12 weeks). Analysis was performed using an analysis of covariance (ANCOVA) model with covariates of treatment, reversibility status (stratum), baseline (week -1) and region. |
| Secondary | Time to First On-treatment Occurrence of Moderate or Severe COPD Exacerbation | From the start of double blind study medication until visit 7 (week 12)/Early withdrawal | Time to first on-treatment exacerbation was analysed using a Cox proportional hazards model with terms for treatment, reversibility status and percent predicted FEV1 at screening. Exacerbation of COPD is defined by a worsening of symptoms requiring additional treatment. Moderate COPD exacerbation is worsening symptoms of COPD that require treatment with antibiotics and/or systemic corticosteroids. Severe COPD exacerbation is worsening symptoms of COPD that require treatment with in-patient hospitalization. The number of participants with On-Treatment moderate or severe COPD exacerbations are presented. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Baseline (BL) in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) FEV1, on Treatment Day 84 | Baseline to Day 84 | Intent-to-Treat (ITT) Population: all randomized par. who received at least one dose of study medication. Number of par. presented represent those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis | Liter | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Rescue-free 24-hour Periods Over the Entire 12-week Treatment Period | BL (Week -1), Week 1 to Week 12 | ITT Population, all randomized participants who received at least one dose of study medication. Only those participants with at least 1 on treatment rescue medication measurement during the treatment period and without missing covariate information were analyzed. | Percentage of rescue-free periods | LEAST_SQUARES_MEAN |
| SECONDARY | Time to First On-treatment Occurrence of Moderate or Severe COPD Exacerbation | From the start of double blind study medication until visit 7 (week 12)/Early withdrawal | ITT Population | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Baseline (BL) in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) FEV1, on Treatment Day 84 | FF/VI 100/25 µg QD | 0.116 | Standard Error 0.0074 | Liter | |
| Mean Change From Baseline (BL) in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) FEV1, on Treatment Day 84 | VI 25 µg QD | 0.082 | Standard Error 0.0075 | Liter | |
| Percentage of Rescue-free 24-hour Periods Over the Entire 12-week Treatment Period | FF/VI 100/25 µg QD | 47.03 | Standard Error 1.070 | Percentage of rescue-free periods | |
| Percentage of Rescue-free 24-hour Periods Over the Entire 12-week Treatment Period | VI 25 µg QD | 44.41 | Standard Error 1.069 | Percentage of rescue-free periods | |
| Time to First On-treatment Occurrence of Moderate or Severe COPD Exacerbation | FF/VI 100/25 µg QD | 69 | Participants | ||
| Time to First On-treatment Occurrence of Moderate or Severe COPD Exacerbation | VI 25 µg QD | 114 | Participants |
Source ClinicalTrials.gov
Participant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| 2 Week Run-in Period | STARTED | Placebo Run-In | 2,423 | |
| 2 Week Run-in Period | STARTED | FF/VI 100/25 µg QD | 0 | |
| 2 Week Run-in Period | STARTED | VI 25 µg QD | 0 | |
| 2 Week Run-in Period | COMPLETED | Placebo Run-In | 1,622 | |
| 2 Week Run-in Period | COMPLETED | FF/VI 100/25 µg QD | 0 | |
| 2 Week Run-in Period | COMPLETED | VI 25 µg QD | 0 | |
| 2 Week Run-in Period | NOT COMPLETED | Placebo Run-In | 801 | |
| 2 Week Run-in Period | NOT COMPLETED | FF/VI 100/25 µg QD | 0 | |
| 2 Week Run-in Period | NOT COMPLETED | VI 25 µg QD | 0 | |
| 12 Week (Wk) Treatment Period (TP) | STARTED | Placebo Run-In | 0 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events114
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | FF/VI 100/25 µg QD | 49 | 806 | |
| other | Nasopharyngitis | Infections and infestations | VI 25 µg QD | 48 | 814 | |
| other | Headache | Nervous system disorders | FF/VI 100/25 µg QD | 29 | 806 | |
| other | Headache | Nervous system disorders | VI 25 µg QD | 19 | 814 | |
| serious | Any event | Respiratory, thoracic and mediastinal disorders | FF/VI 100/25 µg QD | 10 | 806 | |
| serious | Any event | Respiratory, thoracic and mediastinal disorders | VI 25 µg QD | 19 | 814 | |
| serious | Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | FF/VI 100/25 µg QD | 10 | 806 | |
| serious | Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | VI 25 µg QD | 17 | 814 | |
| serious | Chronic respiratory failure | Respiratory, thoracic and mediastinal disorders | FF/VI 100/25 µg QD | 1 | 806 | |
| serious | Chronic respiratory failure | Respiratory, thoracic and mediastinal disorders | VI 25 µg QD | 0 | 814 |
1 to 10 of 114Source ClinicalTrials.gov
See all 114 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | FF/VI 100/25 µg QD | ||
| Total, all-cause mortality | VI 25 µg QD | ||
| Total, other adverse events | FF/VI 100/25 µg QD | 72 | 806 |
| Total, other adverse events | VI 25 µg QD | 64 | 814 |
| Total, serious adverse events | FF/VI 100/25 µg QD | 27 | 806 |
| Total, serious adverse events | VI 25 µg QD | 35 | 814 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28137501 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| FF/VI 100/25 µg QD vs VI 25 µg QD: Time to First On-treatment Occurrence of Moderate or Severe COPD Exacerbation | Trial comparisons |
| FF/VI 100/25 µg QD vs VI 25 µg QD: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02105974
GET https://conductscience.org/api/trials/v1/NCT02105974/flow?page=2