Fluticasone Propionate/Salmeterol Combination (FSC) vs Fluticasone Propionate (FP): Number of Participants Experiencing an Event in the Composite Safety Endpoint of Serious Asthma Outcomes ( Asthma-related Hospitalization, Asthma-related Endotracheal Intubation, or Asthma-related Death)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
Measures 6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0.00583 | 0.00417 | 0.00813 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.00565 | 0.00402 | 0.00792 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | 0.000182 | -0.00263 | 0.003 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 1.03 | 0.64 | 1.66 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 1.03 | 0.639 | 1.67 | log | ClinicalTrials.gov | |
| Number needed to treat, for one more participant with the outcome on Fluticasone Propionate/Salmeterol Combination (FSC) than on Fluticasone Propionate (FP) | 5,490 | from the risk difference interval | the interval includes no difference | ClinicalTrials.gov |
Groups 2
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 | Source |
|---|---|---|---|---|---|---|
| Group 1 | Fluticasone Propionate/Salmeterol Combination (FSC) | Participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg or FSC 500/50 µg as one inhalation twice daily (BID) via Dry powder inhaler (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication. | 34 | 5,834 | OG000 | ClinicalTrials.gov |
| Group 2 | Fluticasone Propionate (FP) | Participants received one of following treatments: FP 100 µg or FP 250 µg or FP 500 µg as one inhalation (BID) via (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication. | 33 | 5,845 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | PRIMARY | ClinicalTrials.gov |
| Title | Number of Participants Experiencing an Event in the Composite Safety Endpoint of Serious Asthma Outcomes ( Asthma-related Hospitalization, Asthma-related Endotracheal Intubation, or Asthma-related Death) | ClinicalTrials.gov |
| Description | Composite endpoint was defined as clinically relevant endpoint that is constructed from combinations of other clinically relevant endpoints of serious asthma outcomes (i.e., asthma-related hospitalization, asthma-related endotracheal intubation, or asthma-related death). Hospitalization was defined as an inpatient stay or a ≥24-hour stay in an observation area in an emergency department or other equivalent facility. Probability of having event was summarized with Kaplan-Meier estimates.Hazard ratio, confidence interval, and p-value are from a stratified Cox proportional hazard model, using randomization stratum as the stratification factor. The 95% CI provided in the table is actually the 95. | ClinicalTrials.gov |
| Time frame | From Day 1 up to 26 weeks | ClinicalTrials.gov |
| Population | Intent to treat (ITT) Population comprised of all participants randomized to study drug and who took study drug. | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | SAS115359: A 6-month Study to Assess the Safety and Benefit of Inhaled Fluticasone Propionate/Salmeterol Combination Compared With Inhaled Fluticasone Propionate in the Treatment of Adolescents and Adults (12 Years of Age and Older) With Asthma. | ClinicalTrials.gov |
| NCT number | NCT01475721 | ClinicalTrials.gov |
| Phases | PHASE4 | ClinicalTrials.gov |
| Conditions | Asthma | ClinicalTrials.gov |
| Interventions | ADVAIR 100/50mcg, ADVAIR 250/50mcg, ADVAIR 500/50mcg, FLOVENT 100mcg, FLOVENT 250mcg, FLOVENT 500mcg | ClinicalTrials.gov |
| Lead sponsor | GlaxoSmithKline | ClinicalTrials.gov |
| Results first posted | 2016-01-14 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT01475721?tab=results | ClinicalTrials.gov |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trial-comparisons-2026-03-23-0.1.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57 | ClinicalTrials.gov |
| AACT copy | 2026-03-23 | ClinicalTrials.gov |
| 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 | ClinicalTrials.gov |
Release trial-comparisons-2026-03-23-0.1.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.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.
ClinicalTrials.gov: none 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.