Therapeutic Equivalence of Fluticasone Propionate Pressurized Metered Dose Inhaler, 110 mcg, to Flovent® HFA 110 mcg
NCT03879837 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1902
Last updated 2021-09-01
Summary
A Randomized, Blinded, Parallel Group, Placebo-Controlled, Multiple Dose, Multicenter Study to Compare the Therapeutic Equivalence of Fluticasone Propionate Pressurized Metered Dose Inhaler, 110 mcg, to Flovent® HFA 110 mcg, in Adult Subjects with Asthma.
Conditions
Interventions
- DRUG
-
Fluticasone propionate pressurized metered dose inhaler
110 mcg per actuation
- DRUG
-
Flovent HFA pressurized metered dose inhaler
110 mcg per actuation
- DRUG
-
Placebo pressurized metered dose inhaler
no active content
Sponsors & Collaborators
-
Teva Pharmaceuticals USA
collaborator INDUSTRY -
Actavis Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-03-25
- Primary Completion
- 2021-05-28
- Completion
- 2021-07-09
- FDA Drug
- Yes
Countries
- United States
Study Locations
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