Trial · NCT01551758
A Randomised Effectiveness Study Comparing Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) With Standard Treatment in Chronic Obstructive Pulmonary Disease (COPD)
NCT01551758, Phase 3, Completed, GlaxoSmithKline; results first posted 2017-03-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Randomised Effectiveness Study Comparing Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) With Standard Treatment in Chronic Obstructive Pulmonary Disease (COPD). Trials, record NCT01551758. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01551758
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Randomised Effectiveness Study Comparing Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) With Standard Treatment in Chronic Obstructive Pulmonary Disease (COPD)
- NCT number
- NCT01551758
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,802 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- FF/VI, Existing Maintenance Therapy
- First posted
- 2012-03-13
- Last updated
- 2017-05-31
- Results first posted
- 2017-03-07
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Annual Rate of Moderate or Severe COPD Exacerbations | Up to 54 weeks | Mean annual rate of moderate or severe COPD exacerbations during treatment were assessed. Moderate exacerbation: participant received exacerbation-related prescription of oral corticosteroids and/ or antibiotic (with/without National Health Service \[NHS\] contact) not requiring hospitalisation. Severe exacerbation: an exacerbation-related hospitalisation. Analysis method was Generalised Linear Model (GLM) assuming the negative binomial distribution with a log-link function and logarithm of time on treatment as an offset variable, adjusted for randomized treatment, baseline COPD maintenance therapy per randomisation stratification, number of moderate/severe COPD exacerbations in previous year and smoking status at baseline. Intent to treat (ITT) population: all randomised participants who received a prescription of study medication. Primary Efficacy Analysis Population: all ITT participants who had at least one moderate/severe exacerbation in the year prior to randomization |
| Secondary | Number of Participants With Serious Adverse Events (SAEs) of Pneumonia During the Study | Up to 58 weeks | Incidence of SAE of pneumonia was defined for each randomized treatment group as the proportion (number) of participants in that group who experienced at least one SAE of pneumonia in the Pneumonia Adverse Event of Special Interest subgroup during the treatment period (from start date of exposure to stop date of exposure + 28 days). Non-inferiority is demonstrated if the upper limit of the two-sided 95% confidence interval for the incidence ratio is less than 2. Serious Adverse Events of pneumonia are defined by the Pneumonia Special Interest Group, which for SAEs of pneumonia collected for these subjects includes the following preferred terms: Pneumonia, Pneumonia aspiration, Aspergillus infection, Empyema, Pneumonia streptococcal, Pneumonitis, Pulmonary tuberculosis. |
| Secondary | Mean Number of Serious Adverse Events of Pneumonia During the Study | Up to 58 weeks | The mean number of SAE of pneumonia over the treatment period (from first date of exposure to last date of exposure + 28 days was calculated. Analysis was performed using a negative binomial regression model with covariates of randomised treatment and with logarithm of time on treatment as an offset variable. |
| Secondary | Time to the First Serious Adverse Event of Pneumonia Occuring in a Year | Up to 52 weeks | The analysis method was a Cox proportional hazards model adjusted for randomized treatment. Analyses included those on-treatment SAEs of pneumonia that had an onset over the first 364 days of exposure, as defined. Participants who did not have an SAE of pneumonia during the first 364 days of the treatment period (start date of exposure to end date of exposure + 28 days were considered censored. Number of participants with event is presented. |
| Secondary | Number of COPD-related Secondary Care Contacts Expressed as Least Square Mean | Up to 54 weeks | A COPD-related secondary care contact was defined as an inpatient admission or a specialist outpatient visit or an accident \& emergency (A\&E) contact. A participant with an A\&E contact and subsequent inpatient admission was considered to have had two healthcare contacts. Inpatient admissions recorded at two hospitals on the same day, this was counted as a single (inpatient admission) secondary care contact. COPD-related contacts were identified using predefined lists of ICD-10 codes, specialty descriptions and diagnosis codes recorded in the patients electronic health record (EHR). GLM assuming the negative binomial distribution with log-link function and logarithm of time on treatment as an offset variable and adjusted for randomised treatment, baseline COPD maintenance therapy per randomisation stratification, number of moderate/severe COPD exacerbations in the previous year to randomisation and smoking status at baseline. |
| Secondary | Number of COPD-related Primary Care Contacts Expressed Using Least Square Mean | Up to 54 weeks | A COPD-related primary care contact was defined as a primary care contact on a given calendar date with either a nurse, general physician (GP) or other healthcare professional that were considered as COPD-related, if the most prominent signs and symptoms the participant was presenting were as a direct result of the participant's COPD, as per Readcodes recorded in the patients electronic health record (EHR). The analysis method was General Linear Model assuming an underlying negative binomial distribution with a log-link function and logarithm of time on treatment as an offset variable and adjusted for randomised treatment, baseline COPD maintenance therapy per randomisation stratification, number of moderate/severe COPD exacerbations in the previous year to randomisation and smoking status at baseline. |
| Secondary | Number of All Secondary Care Contacts Expressed Using Least Square Mean | Up to 54 weeks | A secondary care contact was defined as an inpatient admission or a specialist outpatient visit or an A\&E contact. A participant with an A\&E contact and subsequent inpatient admission was considered to have had two healthcare contacts. In the situation where inpatient admissions were recorded at two hospitals on the same day, this was counted as a single secondary care contact. The analysis method was General Linear Model assuming an underlying negative binomial distribution with a log-link function and logarithm of time on treatment as an offset variable and adjusted for randomised treatment, baseline COPD maintenance therapy per randomization stratification, number of moderate/severe COPD exacerbations in the previous year to randomization and smoking status at baseline. |
| Secondary | Number of All Primary Care Contacts Expressed Using Least Square Mean | Up to 54 weeks | A primary care contact was defined as contact with a either a nurse, general practitioner, or other healthcare professional. The analysis method was General Linear Model assuming an underlying negative binomial distribution with a log-link function and logarithm of time on treatment as an offset variable and adjusted for randomised treatment, baseline COPD maintenance therapy per randomisation stratification, number of moderate/severe COPD exacerbations in the previous year to randomisation and smoking status at baseline. |
| Secondary | Time to an Event of Discontinuation of Initial Therapy Occurring in a Year | Up to 364 days | Initial therapy was defined as the treatment that the subject was randomised to at randomisation. Discontinuation of initial therapy was defined as any modification of initial therapy. These included stepping up, stepping down or switching to another class/class combination, or withdrawal from the study. Switching within the same drug class did not count unless participant switched from FF/VI to a different ICS/LABA. The analysis method was a Cox proportional hazards model adjusted for randomized treatment. The probability of discontinuation of initial therapy was measured from the date of randomisation (i.e., exposure start date) to the date of discontinuation of initial therapy to which the participant was randomized, or date of treatment termination (Visit 6 or early withdrawal visit) for participants who completed the study without discontinuing the initial therapy (censored). Number of participants with event is presented. |
| Secondary | Time to the Addition of a Further COPD Controller Medication Occurring in a Year | Up to 364 days | The date of an event for addition of a further COPD controller medication was defined as the exposure start date of the first modified treatment medication that included a new COPD maintenance therapy of a new class of drug (to the initial therapy) during the study treatment period, as collected on the investigational product page of the eCRF. Participants who did not add any COPD controller medication during the study were censored at the end of the treatment period (Day 364). This was equivalent to stepping up, defined as the addition of at least one new class of drug. The probability of an event was measured from the date of randomisation (i.e., treatment initiation) to the date of a change event. The analysis method was a Cox proportional hazards model adjusted for randomized treatment. Number of participants with event is presented. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Annual Rate of Moderate or Severe COPD Exacerbations | Up to 54 weeks | Primary Efficacy Analysis Population. | Exacerbations per participant per year | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Serious Adverse Events (SAEs) of Pneumonia During the Study | Up to 58 weeks | The Intent-to-Treat (ITT) Population: Defined as all participants who were randomised and received at least one prescription of study medication | Participants | NUMBER |
| SECONDARY | Mean Number of Serious Adverse Events of Pneumonia During the Study | Up to 58 weeks | ITT Population. | Mean Number of SAE | LEAST_SQUARES_MEAN |
| SECONDARY | Time to the First Serious Adverse Event of Pneumonia Occuring in a Year | Up to 52 weeks | ITT Population | Participants | NUMBER |
| SECONDARY | Number of COPD-related Secondary Care Contacts Expressed as Least Square Mean | Up to 54 weeks | ITT Population. | Contacts per participant per year | LEAST_SQUARES_MEAN |
| SECONDARY | Number of COPD-related Primary Care Contacts Expressed Using Least Square Mean | Up to 54 weeks | ITT Population. | Contacts per participant per year | LEAST_SQUARES_MEAN |
| SECONDARY | Number of All Secondary Care Contacts Expressed Using Least Square Mean | Up to 54 weeks | ITT Population. | Contacts per participant per year | LEAST_SQUARES_MEAN |
| SECONDARY | Number of All Primary Care Contacts Expressed Using Least Square Mean | Up to 54 weeks | ITT Population. | Contacts per participant per year | LEAST_SQUARES_MEAN |
| SECONDARY | Time to an Event of Discontinuation of Initial Therapy Occurring in a Year | Up to 364 days | ITT Population | Participants | NUMBER |
| SECONDARY | Time to the Addition of a Further COPD Controller Medication Occurring in a Year | Up to 364 days | ITT Population | Participants | NUMBER |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group34
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Annual Rate of Moderate or Severe COPD Exacerbations | Usual Care | 1.90 | 95% Confidence Interval 1.80 to 2.01 | Exacerbations per participant per year | |
| Mean Annual Rate of Moderate or Severe COPD Exacerbations | FF/VI 100 mcg/25 mcg | 1.74 | 95% Confidence Interval 1.65 to 1.84 | Exacerbations per participant per year | |
| Number of Participants With Serious Adverse Events (SAEs) of Pneumonia During the Study | Usual Care | 83 | Participants | ||
| Number of Participants With Serious Adverse Events (SAEs) of Pneumonia During the Study | FF/VI 100 mcg/25 mcg | 94 | Participants | ||
| Mean Number of Serious Adverse Events of Pneumonia During the Study | Usual Care | 0.07 | 95% Confidence Interval 0.06 to 0.09 | Mean Number of SAE | |
| Mean Number of Serious Adverse Events of Pneumonia During the Study | FF/VI 100 mcg/25 mcg | 0.08 | 95% Confidence Interval 0.06 to 0.09 | Mean Number of SAE | |
| Time to the First Serious Adverse Event of Pneumonia Occuring in a Year | Usual Care | 80 | Participants | ||
| Time to the First Serious Adverse Event of Pneumonia Occuring in a Year | FF/VI 100 mcg/25 mcg | 89 | Participants | ||
| Number of COPD-related Secondary Care Contacts Expressed as Least Square Mean | Usual Care | 1.48 | 95% Confidence Interval 1.30 to 1.67 | Contacts per participant per year | |
| Number of COPD-related Secondary Care Contacts Expressed as Least Square Mean | FF/VI 100 mcg/25 mcg | 1.57 | 95% Confidence Interval 1.39 to 1.78 | Contacts per participant per year |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Usual Care | 1,403 | |
| Overall Study | STARTED | Fluticasone Furoate (FF)/Vilanterol (VI) 100 mcg/25 mcg | 1,396 | |
| Overall Study | COMPLETED | Usual Care | 1,309 | |
| Overall Study | COMPLETED | Fluticasone Furoate (FF)/Vilanterol (VI) 100 mcg/25 mcg | 1,291 | |
| Overall Study | NOT COMPLETED | Usual Care | 94 | |
| Overall Study | NOT COMPLETED | Fluticasone Furoate (FF)/Vilanterol (VI) 100 mcg/25 mcg | 105 |
Source ClinicalTrials.gov
Adverse events918
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 | Oral candidiasis | Infections and infestations | Usual Care | 40 | 1,403 | |
| other | Oral candidiasis | Infections and infestations | FF/VI 100 mcg/25 mcg | 56 | 1,396 | |
| serious | Pneumonia | Infections and infestations | Usual Care | 81 | 1,403 | |
| serious | Pneumonia | Infections and infestations | FF/VI 100 mcg/25 mcg | 89 | 1,396 | |
| serious | Infective exacerbation of chronic obstructive airway disease | Infections and infestations | Usual Care | 47 | 1,403 | |
| serious | Infective exacerbation of chronic obstructive airway disease | Infections and infestations | FF/VI 100 mcg/25 mcg | 50 | 1,396 | |
| serious | Cellulitis | Infections and infestations | Usual Care | 9 | 1,403 | |
| serious | Cellulitis | Infections and infestations | FF/VI 100 mcg/25 mcg | 14 | 1,396 | |
| serious | Lower respiratory tract infection | Infections and infestations | Usual Care | 10 | 1,403 | |
| serious | Lower respiratory tract infection | Infections and infestations | FF/VI 100 mcg/25 mcg | 12 | 1,396 |
1 to 10 of 918Source ClinicalTrials.gov
See all 918 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Usual Care | ||
| Total, all-cause mortality | FF/VI 100 mcg/25 mcg | ||
| Total, other adverse events | Usual Care | 40 | 1,403 |
| Total, other adverse events | FF/VI 100 mcg/25 mcg | 56 | 1,396 |
| Total, serious adverse events | Usual Care | 383 | 1,403 |
| Total, serious adverse events | FF/VI 100 mcg/25 mcg | 404 | 1,396 |
Source ClinicalTrials.gov
Papers8
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 comparisons12
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| FF/VI 100 mcg/25 mcg vs Usual Care: Time to an Event of Discontinuation of Initial Therapy Occurring in a Year | Trial comparisons |
| FF/VI 100 mcg/25 mcg vs Usual Care: Time to the First Serious Adverse Event of Pneumonia Occuring in a Year | Trial comparisons |
| FF/VI 100 mcg/25 mcg vs Usual Care: Number of Participants With Non-serious Adverse Drug Reactions (ADR) | Trial comparisons |
| FF/VI 100 mcg/25 mcg vs Usual Care: Time to First Moderate/Severe Exacerbations on Initial Therapy Occurring in a Year | Trial comparisons |
| FF/VI 100 mcg/25 mcg vs Usual Care: Number of Participants With Serious Adverse Events (SAEs) of Pneumonia During the Study | Trial comparisons |
| FF/VI 100 mcg/25 mcg vs Usual Care: Time to First Moderate/Severe Exacerbations Occurring in a Year | Trial comparisons |
| FF/VI 100 mcg/25 mcg vs Usual Care: Time to the Addition of a Further COPD Controller Medication Occurring in a Year | Trial comparisons |
| FF/VI 100 mcg/25 mcg vs Usual Care: Time to First Severe Exacerbations Occurring in a Year | Trial comparisons |
| FF/VI 100 mcg/25 mcg vs Usual Care: Number of Participants With Serious Adverse Drug Reactions | Trial comparisons |
| FF/VI 100 mcg/25 mcg vs Usual Care: Number of Participants With Serious Adverse Events | Trial comparisons |
1 to 10 of 12
See all 12 trial comparisonsTests0
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/NCT01551758
GET https://conductscience.org/api/trials/v1/NCT01551758/results?page=2