Trials / Completed
CompletedNCT03535870
Clinical Endpoint Bioequivalence Study of Fluticasone Propionate & Salmeterol Xinafoate (100μg/50μg)
A Randomized, Parallel-Group, Placebo-Controlled, Clinical Endpoint Bioequivalence Study of Generic Fluticasone Propionate 100 μg and Salmeterol Xinafoate 50 μg Inhalation Powder Compared With Advair Diskus® 100/50 in Subjects With Asthma
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1,556 (actual)
- Sponsor
- West-Ward Pharmaceutical · Industry
- Sex
- All
- Age
- 12 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
A Randomized, Parallel-Group, Placebo-Controlled, Clinical Endpoint Bioequivalence Study of Generic Fluticasone Propionate 100 μg and Salmeterol Xinafoate 50 μg Inhalation Powder Compared with Advair Diskus® 100/50 in Subjects with Asthma
Detailed description
The primary objective of this study is to evaluate the clinical bioequivalence of generic fluticasone propionate 100 μg and salmeterol xinafoate 50 μg inhalation powder (test) to Advair Diskus ("Advair") 100/50 (reference) for the treatment of asthma. The secondary objectives of the study are: * To demonstrate statistical superiority of generic fluticasone propionate 100 μg and salmeterol xinafoate 50 μg inhalation powder to placebo. * To demonstrate statistical superiority of Advair 100/50 to placebo. * To investigate the safety and tolerability of fluticasone propionate 100 μg and salmeterol xinafoate 50 μg inhalation powder compared with Advair 100/50 in the target population
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Fluticasone propionate/salmeterol | Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the LOMI inhaler device |
| DRUG | Advair Diskus, 100 Mcg-50 Mcg Inhalation Powder | Advair (Fixed dose combination of fluticasone propionate and salmeterol xinafoate administered via the Diskus inhaler device) |
| DRUG | Placebo | placebo dry powder administered via the LOMI inhaler device |
Timeline
- Start date
- 2018-04-26
- Primary completion
- 2019-09-10
- Completion
- 2019-09-10
- First posted
- 2018-05-24
- Last updated
- 2019-11-29
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03535870. Inclusion in this directory is not an endorsement.