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Clinical Endpoint Bioequivalence Study for Fluticasone Propionate and Salmeterol Xinafoate

NCT02649478 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1430

Last updated 2018-01-23

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 / Salmeterol

Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the Vectura LOMI inhaler device

DRUG

Placebo

DRUG

Advair Diskus 100/50

Advair (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate administered via the Diskus inhaler device)

Sponsors & Collaborators

  • Vectura Limited

    collaborator INDUSTRY

  • Roxane Laboratories

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • United States

Study Locations

More Related Trials

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 NCT02649478 on ClinicalTrials.gov