Trial · NCT02345161
A Comparison Study Between the Fixed Dose Triple Combination of Fluticasone Furoate/ Umeclidinium/ Vilanterol Trifenatate (FF/UMEC/VI) With Budesonide/Formoterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
NCT02345161, Phase 3, Completed, GlaxoSmithKline; results first posted 2018-07-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Comparison Study Between the Fixed Dose Triple Combination of Fluticasone Furoate/ Umeclidinium/ Vilanterol Trifenatate (FF/UMEC/VI) With Budesonide/Formoterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD). Trials, record NCT02345161. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02345161
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Comparison Study Between the Fixed Dose Triple Combination of Fluticasone Furoate/ Umeclidinium/ Vilanterol Trifenatate (FF/UMEC/VI) With Budesonide/Formoterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
- NCT number
- NCT02345161
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,811 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- Triple FF/UMEC/VI, Placebo to match FF/UMEC/VI, Budesonide/Formoterol, Placebo to match Budesonide/Formoterol combination, Albuterol/salbutamol
- First posted
- 2015-01-26
- Last updated
- 2018-07-13
- Results first posted
- 2018-07-13
Source ClinicalTrials.gov
Registered outcomes49
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Week 24 | Baseline to Week 24 | FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 at Week 24 was defined as the FEV1 values obtained prior to morning dose of the study treatment. Baseline was defined as the value obtained predose (0 minutes) on Day 1. Change from Baseline was calculated as the pre-dose measurement at Week 24 minus the Baseline value. The analysis was performed using a mixed model repeated measures (MMRM) method including covariates of treatment group, smoking status (screening), geographical region, visit, baseline, baseline by visit and treatment by visit interactions. ITT Population comprised of all randomized subjects excluding those who were randomized in error. Only participants with analyzable data at the given time point were analyzed. |
| Primary | Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Week 52 | Baseline to Week 52 | FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 at Week 52 was defined as the FEV1 values obtained prior to morning dose of the study treatment. Baseline was defined as the value obtained predose (0 minutes) on Day 1. Change from Baseline was calculated as the pre-dose measurement at Week 24 minus the Baseline value. The analysis was performed using a mixed model repeated measures (MMRM) method including covariates of treatment group, smoking status (screening), geographical region, visit, baseline, baseline by visit and treatment by visit interactions. Extension Population: all participants in the ITT Population who were enrolled into the subset of participants with extension to 52 weeks. |
| Primary | Change From Baseline in St George's Respiratory Questionnaire-Chronic Obstructive Pulmonary Disease (COPD; SGRQ) Total Score for COPD Participants at Week 24 | Baseline to Week 24 | The SGRQ-C is a disease-specific questionnaire designed to measure the impact of respiratory disease and its treatment on a COPD participant's health-related quality of life (HRQoL). SGRQ-C total score was converted to SGRQ total score (ranging from 0-100) according to manual. In addition to an overall summary (total) score, scores for the individual domains of Symptoms, Activity, and Impacts (each ranging from 0-100) are produced. A decrease in score indicated improvement in quality of life. The minimum clinically important difference (MCID) for this instrument is a 4-point improvement (decrease from Baseline). Baseline was defined as the value obtained predose on Day 1. Change from Baseline was calculated as total score at Week 24 minus the Baseline value. The analysis for SGRQ total score was performed using a MMRM method including covariates of treatment group, smoking status (screening), geographical region, visit, baseline, baseline by visit and treatment by visit interactions |
| Primary | Change From Baseline in St George's Respiratory Questionnaire-COPD; SGRQ Total Score for COPD Participants at Week 52 | Baseline to Week 52 | The SGRQ-C is a disease-specific questionnaire designed to measure the impact of respiratory disease and its treatment on a COPD participant's health-related quality of life (HRQoL). SGRQ-C total score was converted to SGRQ total score (ranging from 0-100) according to manual. In addition to an overall summary (total) score, scores for the individual domains of Symptoms, Activity, and Impacts (each ranging from 0-100) are produced. A decrease in score indicated improvement in quality of life. The minimum clinically important difference (MCID) for this instrument is a 4-point improvement (decrease from Baseline). Baseline was defined as the value obtained predose on Day 1. Change from Baseline was calculated as total score at Week 52 minus the Baseline value. The analysis for SGRQ total score was performed using a MMRM method including covariates of treatment group, smoking status (screening), geographical region, visit, baseline, baseline by visit and treatment by visit interactions. |
| Secondary | Transitional Dyspnea Index (TDI) Focal Score Expressed as Least Square Mean at Week 24 | Week 24 | The TDI measures change in the participant's dyspnoea from Baseline. The scores in both indexes depend on ratings for three different categories: functional impairment; magnitude of task; and magnitude of effort. Each of these scales had a possible score ranging from -6 (major deterioration) to +6 (major improvement). TDI focal score was calculated as the sum of the three individual scores and then divided by 2 (so the range of the TDI focal score is -9 to +9). TDI was measured at Week 4 and Week 24. Analysis performed using a repeated measures model with covariates of treatment group, smoking status (screening), geographical region, visit, BDI focal score, BDI focal score by visit and treatment by visit interactions. |
| Secondary | Transitional Dyspnea Index (TDI) Focal Score Expressed as Least Square Mean at Week 52 | Week 52 | The TDI measures change in the participant's dyspnoea from Baseline. The scores in both indexes depend on ratings for three different categories: functional impairment; magnitude of task; and magnitude of effort. Each of these scales had a possible score ranging from -6 (major deterioration) to +6 (major improvement). TDI focal score was calculated as the sum of the three individual scores and then divided by 2 (so the range of the TDI focal score is -9 to +9). TDI was measured at Weeks 4, 24 and 52. Analysis performed using a repeated measures model with covariates of treatment group, smoking status (screening), geographical region, visit, BDI focal score, BDI focal score by visit and treatment by visit interactions |
| Secondary | Daily Activity Question Percentage of Days Reporting a Score of 2 up to Week 24 | Up to Week 24 | Participants were asked to complete the daily activity question as part of the eDiary, which included the following options: 0: fewer activities, 1: no affect on my activities, and 2: more activities than usual. Daily activity question percentage of days with score of 2 over Weeks 1-24 was analysed using an ANCOVA model with covariates of treatment group, smoking status (screening), geographical region and baseline. |
| Secondary | Daily Activity Question Percentage of Days Reporting a Score of 2 up to Week 52 | Up to Week 52 | Participants were asked to complete the daily activity question as aprt of the eDiary, which included the following options: 0: fewer activities, 1: no affect on my activities, and 2: more activities than usual. Daily activity question percentage of days with score of 2 over Weeks 1-24 was analysed using an ANCOVA model with covariates of treatment group, smoking status (screening), geographical region and baseline. |
| Secondary | Mean Annual On-treatment Moderate and/or Severe COPD Exacerbations up to Week 24 | Up to Week 24 | The mean annual moderate and severe COPD exacerbations during the treatment (trt) period (per participant \[par.\] per year) was assessed. The event rate for exacerbations was calculated as the number of events x 1000 divided by the total participant exposure during the time-period of interest. An exacerbation of COPD, is defined as the worsening of two or more major symptoms (dyspnea, sputum volume, sputum purulence \[color\]) for at least two consecutive days; or the worsening of any one major symptom together with any one of the minor symptoms (sore throat, cold, fever without other cause, increased cough, increased wheeze) for at least two consecutive days. Analysis performed using a generalised linear model assuming a negative binomial distribution and covariates of treatment group, exacerbation history (0, 1, \>=2 moderate/severe), smoking status (screening), geographical region and post-bronchodilator percent predicted FEV1 (day 1). |
| Secondary | Mean Annual On-treatment Moderate and/or Severe COPD Exacerbations up to Week 52 | Up to Week 52 | The mean annual moderate and severe COPD exacerbations during the treatment (trt) period (per participant \[par.\] per year) was assessed. The event rate for exacerbations was calculated as the number of events x 1000 divided by the total participant exposure during the time-period of interest. An exacerbation of COPD, is defined as the worsening of two or more major symptoms (dyspnea, sputum volume, sputum purulence \[color\]) for at least two consecutive days; or the worsening of any one major symptom together with any one of the minor symptoms (sore throat, cold, fever without other cause, increased cough, increased wheeze) for at least two consecutive days. Analysis performed using a generalised linear model assuming a negative binomial distribution and covariates of treatment group, exacerbation history (0, 1, \>=2 moderate/severe), smoking status (screening), geographical region and post-bronchodilator percent predicted FEV1 (day 1). |
1 to 10 of 49Source ClinicalTrials.gov
See all 49 registered outcomesOutcomes49
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Week 24 | Baseline to Week 24 | ITT Population | Liters (L) | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Week 52 | Baseline to Week 52 | Extension Population; Only participants with analyzable data at the given time point were analyzed. | Liters (L) | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in St George's Respiratory Questionnaire-Chronic Obstructive Pulmonary Disease (COPD; SGRQ) Total Score for COPD Participants at Week 24 | Baseline to Week 24 | ITT Population; Only participants with analyzable data at the given time point were analyzed. | Scores on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in St George's Respiratory Questionnaire-COPD; SGRQ Total Score for COPD Participants at Week 52 | Baseline to Week 52 | Extension Population; Only participants with analyzable data at the given time point were analyzed. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Transitional Dyspnea Index (TDI) Focal Score Expressed as Least Square Mean at Week 24 | Week 24 | ITT Population; Only participants with analyzable data at the given time point were analyzed. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Transitional Dyspnea Index (TDI) Focal Score Expressed as Least Square Mean at Week 52 | Week 52 | Extension Population; Only participants with analyzable data at the given time point were analyzed. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Daily Activity Question Percentage of Days Reporting a Score of 2 up to Week 24 | Up to Week 24 | ITT Population; Only participants with analyzable data at the given time point were analyzed. | Percentage of days | LEAST_SQUARES_MEAN |
| SECONDARY | Daily Activity Question Percentage of Days Reporting a Score of 2 up to Week 52 | Up to Week 52 | Extension Population; Only participants with analyzable data at the given time point were analyzed. | Percentage of days | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Annual On-treatment Moderate and/or Severe COPD Exacerbations up to Week 24 | Up to Week 24 | ITT Population; Only participants with analyzable data at the given time point were analyzed. | Exacerbations per participant per year | MEAN |
| SECONDARY | Mean Annual On-treatment Moderate and/or Severe COPD Exacerbations up to Week 52 | Up to Week 52 | Extension Population; Only participants with analyzable data at the given time point were analyzed. | Exacerbations per participant per year | MEAN |
1 to 10 of 49Source ClinicalTrials.gov
See all 49 outcomesResults by group462
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Week 24 | FF/UMEC/VI 100/62.5/25 µg | 0.142 | Standard Error 0.0083 | Liters (L) | |
| Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Week 24 | BUD/FOR 400/12 µg | -0.029 | Standard Error 0.0085 | Liters (L) | |
| Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Week 52 | FF/UMEC/VI 100/62.5/25 µg | 0.126 | Standard Error 0.0170 | Liters (L) | |
| Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Week 52 | BUD/FOR 400/12 µg | -0.053 | Standard Error 0.0172 | Liters (L) | |
| Change From Baseline in St George's Respiratory Questionnaire-Chronic Obstructive Pulmonary Disease (COPD; SGRQ) Total Score for COPD Participants at Week 24 | FF/UMEC/VI 100/62.5/25 µg | -6.6 | Standard Error 0.45 | Scores on a scale | |
| Change From Baseline in St George's Respiratory Questionnaire-Chronic Obstructive Pulmonary Disease (COPD; SGRQ) Total Score for COPD Participants at Week 24 | BUD/FOR 400/12 µg | -4.3 | Standard Error 0.46 | Scores on a scale | |
| Change From Baseline in St George's Respiratory Questionnaire-COPD; SGRQ Total Score for COPD Participants at Week 52 | FF/UMEC/VI 100/62.5/25 µg | -4.6 | Standard Error 1.01 | Scores on a scale | |
| Change From Baseline in St George's Respiratory Questionnaire-COPD; SGRQ Total Score for COPD Participants at Week 52 | BUD/FOR 400/12 µg | -1.9 | Standard Error 1.03 | Scores on a scale | |
| Transitional Dyspnea Index (TDI) Focal Score Expressed as Least Square Mean at Week 24 | FF/UMEC/VI 100/62.5/25 µg | 2.29 | Standard Error 0.096 | Scores on a scale | |
| Transitional Dyspnea Index (TDI) Focal Score Expressed as Least Square Mean at Week 24 | BUD/FOR 400/12 µg | 1.72 | Standard Error 0.099 | Scores on a scale |
1 to 10 of 462Source ClinicalTrials.gov
See all 462 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | FF/UMEC/VI 100/62.5/25 µg | 911 | |
| Overall Study | STARTED | BUD/FOR 400/12 µg | 899 | |
| Overall Study | COMPLETED | FF/UMEC/VI 100/62.5/25 µg | 866 | |
| Overall Study | COMPLETED | BUD/FOR 400/12 µg | 842 | |
| Overall Study | NOT COMPLETED | FF/UMEC/VI 100/62.5/25 µg | 45 | |
| Overall Study | NOT COMPLETED | BUD/FOR 400/12 µg | 57 |
Source ClinicalTrials.gov
Adverse events156
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/UMEC/VI 100/62.5/25 µg | 72 | 911 | |
| other | Nasopharyngitis | Infections and infestations | BUD/FOR 400/12 µg | 51 | 899 | |
| other | Headache | Nervous system disorders | FF/UMEC/VI 100/62.5/25 µg | 44 | 911 | |
| other | Headache | Nervous system disorders | BUD/FOR 400/12 µg | 56 | 899 | |
| serious | Acute coronory syndrome | Cardiac disorders | FF/UMEC/VI 100/62.5/25 µg | 1 | 911 | |
| serious | Acute coronory syndrome | Cardiac disorders | BUD/FOR 400/12 µg | 0 | 899 | |
| serious | Acute myocardial infarction | Cardiac disorders | FF/UMEC/VI 100/62.5/25 µg | 1 | 911 | |
| serious | Acute myocardial infarction | Cardiac disorders | BUD/FOR 400/12 µg | 1 | 899 | |
| serious | Angina pectoris | Cardiac disorders | FF/UMEC/VI 100/62.5/25 µg | 1 | 911 | |
| serious | Angina pectoris | Cardiac disorders | BUD/FOR 400/12 µg | 1 | 899 |
1 to 10 of 156Source ClinicalTrials.gov
See all 156 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | FF/UMEC/VI 100/62.5/25 µg | ||
| Total, all-cause mortality | BUD/FOR 400/12 µg | ||
| Total, other adverse events | FF/UMEC/VI 100/62.5/25 µg | 105 | 911 |
| Total, other adverse events | BUD/FOR 400/12 µg | 104 | 899 |
| Total, serious adverse events | FF/UMEC/VI 100/62.5/25 µg | 61 | 911 |
| Total, serious adverse events | BUD/FOR 400/12 µg | 64 | 899 |
Source ClinicalTrials.gov
Papers7
The papers the trial lists on ClinicalTrials.gov.
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 comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| FF/UMEC/VI 100/62.5/25 µg vs BUD/FOR 400/12 µg: Number of Participants With at Least One On-treatment Bone Fracture Incident in the Treatment Period | Trial comparisons |
| FF/UMEC/VI 100/62.5/25 µg vs BUD/FOR 400/12 µg: Number of Participants With an On-treatment Penumonia Event in the Extension Part of the Study | Trial comparisons |
| FF/UMEC/VI 100/62.5/25 µg vs BUD/FOR 400/12 µg: Number of Participants With at Least One On-treatment Bone Fracture Incident in the Extension Part of the Study | Trial comparisons |
| Overall Study Arm vs BUD/FOR 400/12 µg: Number of Participants With Any Abnormal Holter Electrocardiogram (ECG) Finding at Week 24 | Trial comparisons |
| FF/UMEC/VI 100/62.5/25 µg vs BUD/FOR 400/12 µg: Number of Participants With an On-treatment Penumonia Event in the Treatment Period | Trial comparisons |
| FF/UMEC/VI 100/62.5/25 µg vs BUD/FOR 400/12 µg: 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.
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