Comparison · NCT01462344-c50fa380
FSC DPI vs FP DPI: Number of Participants Withdrawn From Study Treatment Due to Asthma Exacerbation Over the 6-month Study Treatment Period
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. FSC DPI vs FP DPI: Number of Participants Withdrawn From Study Treatment Due to Asthma Exacerbation Over the 6-month Study Treatment Period. Trial comparisons, record NCT01462344-c50fa380. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01462344-c50fa380
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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 | 0.125 | 0.0901 | 0.17 | wilson | |
| Risk in group 2 | 0.113 | 0.0826 | 0.153 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0113 | -0.0417 | 0.0659 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.1 | 0.704 | 1.72 | log | |
| Odds ratio, group 1 over group 2 | 1.11 | 0.671 | 1.85 | log | |
| Number needed to treat, for one more participant with the outcome on FSC DPI than on FP DPI | 88.8 | 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 | FSC DPI | Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. | 33 | 265 | OG000 |
| Group 2 | FP DPI | Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment. | 35 | 309 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants Withdrawn From Study Treatment Due to Asthma Exacerbation Over the 6-month Study Treatment Period
- Description
An exacerbation is defined as deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days (up to 10 days) or a single depot corticosteroid injection. Number of participants experiencing at least one exacerbation from mITT population were included for this endpoint. The number of participants withdrawn from study treatment due to asthma exacerbation over the 6-month study treatment period are presented.
- Time frame
- From Day 1 up to 6 months
- Population
- mITT Population
Source ClinicalTrials.gov
Trial
- Title
- 6-month Safety and Benefit Study of ADVAIR in Children 4-11 Years Old
- NCT number
- NCT01462344
- Phases
- PHASE4
- Conditions
- Asthma
- Interventions
- ADVAIR 100/50mcg, ADVAIR 250/50mcg, FLOVENT 100mcg, FLOVENT 250mcg
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2016-10-05
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01462344?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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