Trials / Completed
CompletedNCT03676413
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
A Phase III, Randomized, Multicenter, Parallel-group 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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 451 (actual)
- Sponsor
- Respirent Pharmaceuticals Co Ltd. · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Fluticasone Propionate 100 mcg and Salmeterol 50 mcg inhalation Powder/Respirent Pharmaceuticals | new generic product of Fluticasone Propionate 100 mcg and Salmeterol 50 mcg Inhalation Powder twice daily inhalation throughout the study |
| DRUG | ADVAIR DISKUS® 100/50 mcg inhalation powder pre-dispensed/GSK | twice daily inhalation throughout the study |
| DRUG | Placebo | twice daily inhalation throughout the study |
Timeline
- Start date
- 2018-10-02
- Primary completion
- 2019-08-02
- Completion
- 2020-06-30
- First posted
- 2018-09-18
- Last updated
- 2020-07-07
Locations
1 site across 1 country: Greece
Source: ClinicalTrials.gov record NCT03676413. Inclusion in this directory is not an endorsement.