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Bioequivalence With Clinical Endpoint Study of Fluticasone Propionate 100 mcg and Salmeterol 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 100/50 mcg Inhalation Powder/GSK in Patients With Asthma

NCT05664061 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 451

Last updated 2023-03-01

No results posted yet for this study

Summary

Τherapeutic equivalence, randomized, multiple-dose, placebo-controlled, observer-blind, parallel group design consisting of a 2-week run-in period followed by a 4-week treatment period with Fluticasone propionate 100 mcg and Salmeterol 50 mcg inhalation powder/Respirent Pharmaceuticals (Test) or ADVAIR DISKUS® 100/50 mcg (Reference) or placebo.

Conditions

Interventions

DRUG

Fluticasone Propionate 100 mcg and Salmeterol 50 mcg inhalation Powder/Respirent Pharmaceuticals

twice daily inhalation throughout the treatment period

DRUG

ADVAIR DISKUS® 100/50 mcg inhalation powder pre-dispensed/GSK

twice daily inhalation throughout the treatment period

DRUG

Placebo

twice daily inhalation throughout the treatment period

Sponsors & Collaborators

  • Becro Ltd.

    collaborator INDUSTRY

  • Respirent Pharmaceuticals Co Ltd.

    lead INDUSTRY

Principal Investigators

  • Konstantinos Kostikas, Professor · University of Ioannina School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-30
Primary Completion
2023-07-31
Completion
2023-12-31
FDA Drug
Yes

Countries

  • Greece

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 NCT05664061 on ClinicalTrials.gov