drugset / Trial / NCT03676413
A Clinical Trial for Examining the Therapeutic Equivalence Between Fluticasone Propionate 100 mcg and Salmeterol 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 100/50 mcg Inhalation Powder/GSK in Patients With Asthma
RandomizedParallel-groupTriple-blindOther
Summary
Τherapeutic equivalence, randomized, multiple-dose, placebo-controlled, observer-blind, parallel group design consisting of a 2-week run-in period followed by a 4-week treatment period with Fluticasone propionate 100 mcg and Salmeterol 50 mcg inhalation powder/Respirent Pharmaceuticals (Test) or ADVAIR DISKUS® 100/50 mcg (Reference) or placebo.
Timeline
- Start
- 2018-10-02
- Primary completion
- 2019-08-02
- Completion
- 2020-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Fluticasone propionate | Other / unclassified | 100 ug | Inhaled |
| Comparator | Fluticasone propionate | Other / unclassified | — | Inhaled |
| Subject | Salmeterol | Other / unclassified | 50 ug | Inhaled |