Comparison · NCT01086384-90e65cf8
FF 100 µg vs FF/VI 100/25 µg: Number of Participants With 1 or More Severe Asthma Exacerbations
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 100 µg vs FF/VI 100/25 µg: Number of Participants With 1 or More Severe Asthma Exacerbations. Trial comparisons, record NCT01086384-90e65cf8. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01086384-90e65cf8
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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 | 0.184 | 0.161 | 0.209 | wilson | |
| Risk in group 2 | 0.153 | 0.132 | 0.176 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0315 | -0.00114 | 0.0642 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.21 | 0.993 | 1.47 | log | |
| Odds ratio, group 1 over group 2 | 1.25 | 0.992 | 1.58 | log | |
| Number needed to treat, for one more participant with the outcome on FF 100 µg than on FF/VI 100/25 µg | 31.7 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | FF 100 µg | Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a dry powder inhaler (DPI) once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period. | 186 | 1,010 | OG000 |
| Group 2 | FF/VI 100/25 µg | Participants received FF/vilanterol (VI) 100/25 µg inhalation powder via a DPI once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period. | 154 | 1,009 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With 1 or More Severe Asthma Exacerbations
- Description
Asthma is a medical condition that causes narrowing of the small airways in the lungs. A severe asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. Only events deemed by the adjudication committee to be severe asthma exacerbations were used in the analysis of severe asthma exacerbations. The time to the first severe asthma exacerbation was analyzed using a Cox proportional hazards regression model, adjusting for Baseline disease severity (Baseline forced expiratory volume in one second \[FEV1, maximum amount of air forcefully exhaled in one second\]), sex, age, and region.
- Time frame
- Baseline to Follow-up (up to 76 weeks of treatment)
- Population
- Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study medication.
Source ClinicalTrials.gov
Trial
- Title
- Asthma Exacerbation Study
- NCT number
- NCT01086384
- Phases
- PHASE3
- Conditions
- Asthma
- Interventions
- Fluticasone Furoate/GW642444, Fluticasone furoate
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2013-09-11
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01086384?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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