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

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.

Timeline

Start

2026-04-21

Primary completion

2026-04-21

Completion

2026-04-21

Outcome

Outcome not reported

Stopped (Business): “In response to evolving regulations, product specific guidance by Health Authorities globally, Sandoz plans to streamline its clinical development programs and has therefore strategically decided to discontinue the SAN 1138 clinical study.”

Drugs

Indications