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Therapeutic Equivalence of Two Formulations of Fluticasone Propionate and Salmeterol Inhalation Powder in Subjects With Asthma

NCT03756883 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 999

Last updated 2021-09-24

Study results available
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Summary

A randomized, multiple-dose, blinded, placebo-controlled, parallel-group, multiple-center bioequivalence study with pharmacodynamic endpoints

Conditions

Interventions

DRUG

Fluticasone Propionate and Salmeterol Inhalation Powder

100/50 mcg per actuation

DRUG

Fluticasone Propionate and Salmeterol Inhalation Powder

100/50 mcg per actuation

DRUG

Placebo Inhalation Powder

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
12 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-03
Primary Completion
2019-10-26
Completion
2019-11-10
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03756883 on ClinicalTrials.gov