drugset / Trial / NCT01772368
Dose Ranging Study of the Salmeterol Component of Fluticasone /Salmeterol Spiromax Compared to Fluticasone Spiromax and Advair Diskus in Asthma Subjects
RandomizedCrossoverDouble-blindTreatment
Summary
The primary objective of this study is to evaluate the dose response, efficacy, and safety of 4 different doses of salmeterol Spiromax (6.25, 12.5, 25, and 50 mcg) each combined with a fixed dose of fluticasone propionate (100 mcg) delivered as Fluticasone/Salmeterol Spiromax® Inhalation Powder (FS Spiromax) when administered as a single dose in subjects 12 years of age and older with persistent asthma.
Timeline
- Start
- 2013-01
- Primary completion
- 2013-06
- Completion
- 2013-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Fluticasone propionate | Other / unclassified | 100 ug | Inhaled |
| Subject | salmeterol xinafoate | Unknown | 6.25 ug | Inhaled |
| Subject | salmeterol xinafoate | Unknown | 12.5 ug | Inhaled |
| Subject | salmeterol xinafoate | Unknown | 25 ug | Inhaled |
| Subject | salmeterol xinafoate | Unknown | 50 ug | Inhaled |
| Background | Salbutamol | Unknown | — | Inhaled |