Comparison · NCT01687296-sae
Fluticasone Propionate vs Prednisone: serious adverse events
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. Fluticasone Propionate vs Prednisone: serious adverse events. Trial comparisons, record NCT01687296-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01687296-sae
On this page
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 | 0.00813 | 0.00144 | 0.0446 | wilson | |
| Risk in group 2 | 0.0156 | 0.0043 | 0.0552 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00749 | -0.0476 | 0.0307 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.52 | 0.0478 | 5.67 | log | |
| Odds ratio, group 1 over group 2 | 0.516 | 0.0462 | 5.77 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Fluticasone Propionate than on Prednisone | 133 | 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 | Fluticasone Propionate | Participants received fluticasone propionate inhalation solution BID 2x0.5 mg/mL via a nebulizer in morning and evening for 7 days. Blinding was maintained by administration of placebo soluble tablets once daily in the morning for 7 days. Salbutamol was provided on a needed basis throughout the treatment period. | 1 | 123 | EG000 |
| Group 2 | Prednisone | Participants received oral prednisone tablets once daily at 2 mg per kg per day, up to 40 mg per day for 4 days, then 1 mg per kg per day or half of the original dose, up to 20 mg per day for 3 days in the morning. Blinding was maintained by administration of placebo nebules 2×2mL 0.9% saline BID in morning and evening for 7 days. Salbutamol was provided on a needed basis throughout the treatment period. | 2 | 128 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
On- treatment serious adverse events (SAE) and non- serious adverse events (AE) were collected from start of study medication through the treatment phase up to 8 days (only on-treatment events captured).
Source ClinicalTrials.gov
Trial
- Title
- Nebulized Fluticasone Propionate VS Oral Prednisone in Chinese Pediatric and Adolescent Subjects With an Acute Exacerbation of Asthma
- NCT number
- NCT01687296
- Phases
- PHASE3
- Conditions
- Asthma
- Interventions
- fluticasone propionate inhalation solution, oral prednisone, placebo inhalation solution, placebo tablet, salbutamol
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2018-01-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01687296?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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT01687296-sae