Study of Fluticasone Propionate Multidose Dry Powder Inhaler Compared With Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler
Summary
This study is to evaluate the safety and efficacy of fluticasone propionate and fluticasone propionate salmeterol in pediatric participants with a documented history of persistent asthma.
Timeline
- Start
- 2016-12-28
- Primary completion
- 2019-04-07
- Completion
- 2019-04-13
Outcome
Mixed primary results
registry analysis (superiority test); Fp MDPI 50 mcg BID vs FS MDPI 50/12.5 mcg BID; p = 0.285 NCT02980133 ↗
registry LEAST_SQUARES_MEAN Fp MDPI 50 mcg BID: 16.4 (Standard Error 1.32) percent predicted of FEV1 NCT02980133 ↗
registry analysis (superiority test); Placebo MDPI vs Fp MDPI 25 mcg BID; p <0.001; Least square (LS) mean difference 6.0 (95% CI 3.2 to 8.8) NCT02980133 ↗
registry analysis (superiority test); Placebo MDPI vs Fp MDPI 50 mcg BID; p <0.001; LS mean difference 7.0 (95% CI 4.1 to 9.8) NCT02980133 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fluticasone propionate | Other / unclassified | 25 ug | Inhaled |
| Subject | Fluticasone propionate | Other / unclassified | 50 ug | Inhaled |
| Subject | Salmeterol | Other / unclassified | 12.5 ug | Inhaled |