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Clinical Endpoint Bioequivalence Study of Fluticasone Propionate & Salmeterol Xinafoate (100μg/50μg)

NCT03535870 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1556

Last updated 2019-11-29

No results posted yet for this study

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

Conditions

Interventions

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

Sponsors & Collaborators

  • West-Ward Pharmaceutical

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-26
Primary Completion
2019-09-10
Completion
2019-09-10

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT03535870 on ClinicalTrials.gov