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BE Study of Fluticasone Propionate/Salmeterol Inhalation Powder in Asthma Patients

NCT03394989 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1366

Last updated 2020-08-13

No results posted yet for this study

Summary

The purpose of this study is to demonstrate the pharmacodynamic bioequivalence of the test product to the reference product in adult patients with asthma.

Conditions

  • Bronchial Asthma

Interventions

DRUG

Fluticasone propionate/salmeterol 100/50 µg

Test Arm: Dry powder inhaler

OTHER

Placebo

Placebo

DRUG

Advair Diskus 100/50 Dry Powder Inhaler, 60 ACTUAT

Comparator Arm: Dry powder inhaler

Sponsors & Collaborators

  • Cipla Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-17
Primary Completion
2019-12-03
Completion
2020-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03394989 on ClinicalTrials.gov