A Study of the Effectiveness and Safety of Different Doses of Fluticasone Propionate Taken From a Dry Powder Inhaler in Adolescents and Adults Who Have Asthma That is Not Controlled by Asthma Medications Not Containing Steroids
Summary
This is a randomized, double-blind, placebo- and open-label active controlled, parallel-group, multicenter, dose ranging study in male or female subjects ages 12 years and older with persistent asthma who are uncontrolled on non-steroidal therapy. The primary objective of this study is to evaluate the dose response, efficacy and safety of 4 different doses of fluticasone propionate delivered as Fluticasone Propionate DPI (Dry Powder Inhaler) when administered twice daily.
Timeline
- Start
- 2012-01
- Primary completion
- 2013-07
- Completion
- 2013-07
Outcome
Met primary endpoint
registry analysis (superiority or other test); Fp MDPI 100 mcg vs Placebo MDPI; p = 0.0005; LSM difference 0.149 (95% CI 0.066 to 0.233) NCT01479621 ↗
registry analysis (superiority or other test); Fp MDPI 12.5 mcg vs Fp MDPI 25 mcg vs Fp MDPI 50 mcg vs Fp MDPI 100 mcg vs Placebo MDPI; p = 0.0001; Regression, Linear NCT01479621 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fluticasone propionate | Other / unclassified | 12.5 ug | Inhaled |
| Subject | Fluticasone propionate | Other / unclassified | 25 ug | Inhaled |
| Subject | Fluticasone propionate | Other / unclassified | 50 ug | Inhaled |
| Subject | Fluticasone propionate | Other / unclassified | 100 ug | Inhaled |
| Background | Salbutamol | Unknown | — | Inhaled |