Comparison · NCT01551758-cd811412
FF/VI 100 mcg/25 mcg vs Usual Care: Time to the Addition of a Further COPD Controller Medication Occurring in a Year
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. 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, record NCT01551758-cd811412. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01551758-cd811412
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0516 | 0.0412 | 0.0645 | wilson | |
| Risk in group 2 | 0.101 | 0.0865 | 0.118 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0496 | -0.0695 | -0.0301 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.51 | 0.388 | 0.67 | log | |
| Odds ratio, group 1 over group 2 | 0.483 | 0.36 | 0.648 | log | |
| Number needed to treat, for one fewer participant with the outcome on FF/VI 100 mcg/25 mcg than on Usual Care | 20.1 | 14.4 | 33.2 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: usual care.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | FF/VI 100 mcg/25 mcg | Participants were prescribed one inhalation of fluticasone furoate/vilanterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally. | 72 | 1,396 | OG001 |
| Group 2 | Usual Care | Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months | 142 | 1,403 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Time to the Addition of a Further COPD Controller Medication Occurring in a Year
- Description
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.
- Time frame
- Up to 364 days
- Population
- ITT Population
Source ClinicalTrials.gov
Trial
- 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
- Phases
- PHASE3
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- FF/VI, Existing Maintenance Therapy
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2017-03-07
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01551758?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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