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

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.

Eligibility

Age range

18–75 years

Sex

All

Healthy volunteers

No

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

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