Trial · NCT01313676
Study to Evaluate the Effect of Fluticasone Furoate/Vilanterol on Survival in Subjects With Chronic Obstructive Pulmonary Disease
NCT01313676, Phase 3, Completed, GlaxoSmithKline; results first posted 2016-08-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate the Effect of Fluticasone Furoate/Vilanterol on Survival in Subjects With Chronic Obstructive Pulmonary Disease. Trials, record NCT01313676. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01313676
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Effect of Fluticasone Furoate/Vilanterol on Survival in Subjects With Chronic Obstructive Pulmonary Disease
- NCT number
- NCT01313676
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 16,568 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- fluticasone furoate/vilanterol, fluticasone furoate, vilanterol, Placebo
- First posted
- 2011-03-14
- Last updated
- 2018-08-06
- Results first posted
- 2016-08-09
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Death (Both on and Off Treatment) Due to Any Cause, Time up to or on the Pre-determined Common End Date | From the date of randomization until date of death due to any cause (average of 2 study years) | Death from any cause: which occurred from the day of starting IP until the Commone End Date (CED). Common End Date (CED) is the study end date that was pre determined where approximately 1000 deaths would have occurred in the Intent-toTreat Efficacy (ITT-E) Population. Only deaths which occurred on or before the CED were used for the primary analysis. Those who had not died by CED, but who were known to be alive on or after the CED, were censored at the CED. Cox Proportional Hazards (PH) Model was adjusted for age, and gender, including all 4 arms. A hazard ratio of less than 1 indicates a lower death rate versus placebo or other arm. ITT-E Population consisted of all participants in the Safety Population (i.e. randomized to IP and who received at least one dose of IP), with the exception of those recruited at sites that were closed. |
| Secondary | Decline in Forced Expiratory Volume in 1 Second (FEV1) | From start date of IP until IP stop date + 1 (assessed up to 4 years) | FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The effect of treatment on decline of post bronchodilator FEV1 recorded during the treatment period was analyzed using a particular form of a mixed effect model - a random coefficients model. FEV1 was fitted as the response variable with treatment group, age, gender, baseline FEV1 and time on treatment as fixed effects. Time on treatment was treated as a continuous variable. This model allowed for an initial increase in FEV1, but then tested the difference in slopes from the first post-baseline measurement which was at 3 months. A negative slope indicates a decline. A positive treatment difference indicates a slower rate of decline vs Placebo or Component. Only participants with at least one on-treatment post-bronchodilator FEV1 measurement were analyzed. |
| Secondary | Number of Participants With First On-treatment Cardiovascular (CV) Composite Events Occured on or Before Common End Date | From the start of IP to first on treatment CV event till 7 days after the last dose of IP (average of 2 study years) | On-treatment CV composite event is comprised of the first event that is adjudicated as on-treatment CV death, myocardial infarction, stroke, unstable angina, or transient ischemic attack experienced by a participant. The events that occurred no more than 7 days after the participants last dose of IP are considered as on-treatment adverse events. Common end date is the study end date where approximately 1000 deaths would have occurred in the ITT-E Population. Cox PH Model was used to assess time to first on-treatment CV composite event. Cox PH Model was adjusted for age, gender and indicators of ischemic and vascular disease, including all four treatment arms. A hazard ratio less than 1 indicates a lower risk of a first CV event rate versus placebo or any arm. |
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 | Number of Participants With Death (Both on and Off Treatment) Due to Any Cause, Time up to or on the Pre-determined Common End Date | From the date of randomization until date of death due to any cause (average of 2 study years) | ITT-E Population | Participants | NUMBER |
| SECONDARY | Decline in Forced Expiratory Volume in 1 Second (FEV1) | From start date of IP until IP stop date + 1 (assessed up to 4 years) | ITT-E Population | milliliter/year | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With First On-treatment Cardiovascular (CV) Composite Events Occured on or Before Common End Date | From the start of IP to first on treatment CV event till 7 days after the last dose of IP (average of 2 study years) | ITT-E Population | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Death (Both on and Off Treatment) Due to Any Cause, Time up to or on the Pre-determined Common End Date | Placebo | Dead | 275 | Participants | |
| Number of Participants With Death (Both on and Off Treatment) Due to Any Cause, Time up to or on the Pre-determined Common End Date | Fluticasone Furoate 100 µg | Dead | 251 | Participants | |
| Number of Participants With Death (Both on and Off Treatment) Due to Any Cause, Time up to or on the Pre-determined Common End Date | Vilanterol 25 µg | Dead | 265 | Participants | |
| Number of Participants With Death (Both on and Off Treatment) Due to Any Cause, Time up to or on the Pre-determined Common End Date | Fluticasone Furoate/Vilanterol 100/25 µg | Dead | 246 | Participants | |
| Number of Participants With Death (Both on and Off Treatment) Due to Any Cause, Time up to or on the Pre-determined Common End Date | Placebo | Alive | 3832 | Participants | |
| Number of Participants With Death (Both on and Off Treatment) Due to Any Cause, Time up to or on the Pre-determined Common End Date | Fluticasone Furoate 100 µg | Alive | 3884 | Participants | |
| Number of Participants With Death (Both on and Off Treatment) Due to Any Cause, Time up to or on the Pre-determined Common End Date | Vilanterol 25 µg | Alive | 3853 | Participants | |
| Number of Participants With Death (Both on and Off Treatment) Due to Any Cause, Time up to or on the Pre-determined Common End Date | Fluticasone Furoate/Vilanterol 100/25 µg | Alive | 3874 | Participants | |
| Number of Participants With Death (Both on and Off Treatment) Due to Any Cause, Time up to or on the Pre-determined Common End Date | Placebo | Unknown | 4 | Participants | |
| Number of Participants With Death (Both on and Off Treatment) Due to Any Cause, Time up to or on the Pre-determined Common End Date | Fluticasone Furoate 100 µg | Unknown | 0 | Participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 4,131 | |
| Overall Study | STARTED | Fluticasone Furoate 100 µg | 4,157 | |
| Overall Study | STARTED | Vilanterol 25 µg | 4,140 | |
| Overall Study | STARTED | Fluticasone Furoate/Vilanterol 100/25 µg | 4,140 | |
| Overall Study | COMPLETED | Placebo | 2,881 | |
| Overall Study | COMPLETED | Fluticasone Furoate 100 µg | 3,044 | |
| Overall Study | COMPLETED | Vilanterol 25 µg | 3,052 | |
| Overall Study | COMPLETED | Fluticasone Furoate/Vilanterol 100/25 µg | 3,146 | |
| Overall Study | NOT COMPLETED | Placebo | 1,250 | |
| Overall Study | NOT COMPLETED | Fluticasone Furoate 100 µg | 1,113 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events4,224
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 | Bronchitis | Infections and infestations | Placebo | 165 | 4,131 | |
| other | Bronchitis | Infections and infestations | Fluticasone Furoate 100 µg | 184 | 4,157 | |
| other | Bronchitis | Infections and infestations | Vilanterol 25 µg | 168 | 4,140 | |
| other | Bronchitis | Infections and infestations | Fluticasone Furoate/Vilanterol 100/25 µg | 166 | 4,140 | |
| other | Influenza | Infections and infestations | Placebo | 118 | 4,131 | |
| other | Influenza | Infections and infestations | Fluticasone Furoate 100 µg | 116 | 4,157 | |
| other | Influenza | Infections and infestations | Vilanterol 25 µg | 122 | 4,140 | |
| other | Influenza | Infections and infestations | Fluticasone Furoate/Vilanterol 100/25 µg | 137 | 4,140 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 310 | 4,131 | |
| other | Nasopharyngitis | Infections and infestations | Fluticasone Furoate 100 µg | 366 | 4,157 |
1 to 10 of 4,224Source ClinicalTrials.gov
See all 4,224 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Fluticasone Furoate 100 µg | ||
| Total, all-cause mortality | Vilanterol 25 µg | ||
| Total, all-cause mortality | Fluticasone Furoate/Vilanterol 100/25 µg | ||
| Total, other adverse events | Placebo | 1,862 | 4,131 |
| Total, other adverse events | Fluticasone Furoate 100 µg | 1,941 | 4,157 |
| Total, other adverse events | Vilanterol 25 µg | 1,827 | 4,140 |
| Total, other adverse events | Fluticasone Furoate/Vilanterol 100/25 µg | 1,761 | 4,140 |
| Total, serious adverse events | Placebo | 918 | 4,131 |
| Total, serious adverse events | Fluticasone Furoate 100 µg | 929 | 4,157 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers17
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01313676
GET https://conductscience.org/api/trials/v1/NCT01313676/results?page=2