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NOT YET RECRUITING
NCT07223294
PHASE3

Study to Evaluate the Therapeutic Equivalence and Safety of Fluticasone Furoate and Vilanterol Inhalation Powder 100 mcg/25 mcg and BREO ELLIPTA 100 mcg/25 mcg in Participants With Asthma

Sponsor: Sandoz

View on ClinicalTrials.gov

Summary

This is a randomized, multi-center, multiple-dose, double-blind, placebo-controlled, Parallel group design, clinical endpoint bioequivalence study in adult participants with asthma. The study design includes up to a 2-week Screening period, at least a 2-week Run-in period, a 4-week Treatment period, and a safety follow up call one week later. Visit 1: Screening Visit 2: Run-in period: All eligible participants will enter a 2-week Run-in period in which training will be provided to the participants on the use of inhalers and participant diary. Visit 3: Day 1: Randomization to one of the 3 treatment groups to receive one inhalation of the study medication quaque die (QD), in the morning, for 28 ± 2 days. Visit 4: Day 28: EOT Participants will be contacted one week after their last site visit for Safety follow-up via phone call (end of study). Participants will be instructed to refrain from taking their current inhaled asthma medications from the start of the Run-in period until the end of treatment (EOT) visit. They will be provided with a salbutamol/albuterol inhaler (rescue medication) for use on an as-needed basis during the entire study duration until the EOT visit.

Official title: A Randomized, Multicenter, Multiple-dose, Double-blind, Placebo-controlled, Parallel-group Design, Clinical Endpoint Bioequivalence Study to Evaluate the Therapeutic Equivalence and Safety of Fluticasone Furoate and Vilanterol Inhalation Powder 100 mcg/25 mcg (Sandoz) and BREO® ELLIPTA® (Fluticasone Furoate and Vilanterol Inhalation Powder) 100 mcg/25 mcg (GlaxoSmithKline) in Adult Participants With Asthma

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

1430

Start Date

2026-04

Completion Date

2026-10-31

Last Updated

2026-02-05

Healthy Volunteers

No

Conditions

Interventions

COMBINATION_PRODUCT

Fluticasone furoate and vilanterol inhalation powder

Fluticasone furoate and vilanterol inhalation powder 100 mcg/25 mcg

COMBINATION_PRODUCT

Breo Ellipta

Fluticasone furoate and Vilanterol inhalation powder) 100 mcg/25 mcg

COMBINATION_PRODUCT

Placebo

Inhalation powder with lactose

Locations (6)

Sandoz Investigational Site

Cullman, Alabama, United States

Sandoz Investigational Site

Bradenton, Florida, United States

Sandoz Investigational Site

Leesburg, Florida, United States

Sandoz Investigational Site

Orlando, Florida, United States

Sandoz Investigational Site

St Louis, Missouri, United States

Sandoz Investigational Site

Raleigh, North Carolina, United States