Efficacy and Safety of Fluticasone Propionate(FP)/ Salmeterol Xinafoate (SLM) Hydro Fluoro Alkane (HFA) Metered Dose Inhaler (MDI) in Pediatric Patients With Bronchial Asthma
Summary
This study is a multicenter, stratified, randomized, active control, double-blinded, parallel-group comparative study with an open-label extension period. The study is designed to evaluate the efficacy and safety of FP/ SLM HFA MDI 50/25 microgram (mcg) one or two inhalation twice daily (BID) for 8 weeks in comparison with FP HFA MDI 50 mcg one or two inhalation BID, in 6-month to 4-year-old Japanese patients with bronchial asthma. The study is also designed to evaluate the safety of long-term treatment of FP/ SLM HFA MDI 50/25 mcg one or two BID for 16 weeks. The subjects meeting the eligibility criteria will enter the run-in period of 2 weeks and receive FP 50 mcg 1 or 2 inhalation bid (FP 100 or 200 mcg/day), before randomization. The subjects under 2 years of age at Visit 1 will receive only 1 inhalation bid during the run-in period. The subjects who meet the eligibility criteria for randomization will be stratified according to their age (\<2 or \>=2 year-old) at Visit 1 and randomized to one of the two treatment groups. The total duration of participation in the study will be 10 weeks for a comparison period completion and 27 weeks for a completion.
Timeline
- Start
- 2014-05-01
- Primary completion
- 2016-06-01
- Completion
- 2016-10-01
Outcome
Missed primary endpoint
registry analysis (superiority or other test); FP HFA 50 µg vs FP/SLM HFA 50/25 µg; p = 0.206; Difference in Least square means -0.97 (95% CI -2.47 to 0.54); ANCOVA NCT02113436 ↗
paper The between-group difference was not statistically significant (P0.21; 95% confidence interval: -2.47, 0.54). PMID 30556939 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fluticasone propionate | Other / unclassified | 50 ug | Inhaled |
| Subject | Salmeterol | Other / unclassified | 25 ug | — |