MedTrace Logo

A Clinical Trial for Examining the Therapeutic Equivalence Between Fluticasone Propionate 100 mcg/Blister Oral Inhalation Powder/Respirent Pharmaceuticals vs. FLOVENT DISKUS® 100mcg/Blister Oral Inhalation Powder/GSK in Patients With Asthma

NCT04665895 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 451

Last updated 2023-04-06

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/ blister oral inhalation powder/Respirent Pharmaceuticals (Test) or FLOVENT DISKUS® 100mcg blister oral inhalation powder (Reference) or placebo.

Conditions

Interventions

DRUG

Fluticasone propionate 100 mcg/blister oral inhalation powder/Respirent Pharmaceuticals

twice daily inhalation throughout the study

DRUG

FLOVENT DISKUS® 100 mcg/blister oral inhalation powder/GSK

twice daily inhalation throughout the study

DRUG

Placebo

twice daily inhalation throughout the study

Sponsors & Collaborators

  • Becro Ltd.

    collaborator INDUSTRY

  • Respirent Pharmaceuticals Co Ltd.

    lead INDUSTRY

Principal Investigators

  • Konstantinos Kostikas, Associate Professor · University of Ioannina Department 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
2020-12-09
Primary Completion
2021-08-13
Completion
2022-02-22
FDA Drug
Yes

Countries

  • Greece

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 NCT04665895 on ClinicalTrials.gov