Comparison · NCT01706198-32785f41
FF/VI vs Usual Care: Time to First Severe Asthma Exacerbation.
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 vs Usual Care: Time to First Severe Asthma Exacerbation. Trial comparisons, record NCT01706198-32785f41. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01706198-32785f41
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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 | 0.3 | 0.281 | 0.32 | wilson | |
| Risk in group 2 | 0.309 | 0.289 | 0.329 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00873 | -0.0364 | 0.019 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.972 | 0.887 | 1.06 | log | |
| Odds ratio, group 1 over group 2 | 0.96 | 0.842 | 1.09 | log | |
| Number needed to treat, for one fewer participant with the outcome on FF/VI than on Usual Care | 115 | from the risk difference interval | the interval includes no difference |
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 | Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler. | 634 | 2,114 | OG001 |
| Group 2 | Usual Care | Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers). | 654 | 2,119 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Time to First Severe Asthma Exacerbation.
- Description
A severe asthma exacerbation is defined as deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) or antibiotics, and inpatient hospitalization, or emergency department visit due to asthma that required systemic corticosteroids or antibiotics. The date of a severe asthma exacerbation was defined as the exacerbation onset date. Participants who completed the study without a severe asthma exacerbation were censored. Time to first severe asthma exacerbation was measured from the date of randomization (that is, study treatment start date) to the onset date of first severe asthma exacerbation, or study treatment stop date for participants who completed the study without any severe asthma exacerbations (censored). Analyses of time to first severe asthma exacerbation was censored at Day 364. The number of participants with severe asthma exacerbation has been presented.
- Time frame
- Up to Week 52
- Population
- ITT Population
Source ClinicalTrials.gov
Trial
- Title
- An Effectiveness Study Comparing Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) With Standard Treatment in Asthma
- NCT number
- NCT01706198
- Phases
- PHASE3
- Conditions
- Asthma
- Interventions
- fluticasone furoate + vilanterol, inhaled corticosteroid with or without a long acting beta2-agonist
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2019-01-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01706198?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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