Stopped: 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.
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.
Age range
18 Years – 75 Years
Sex
ALL
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Demonstrate the therapeutic equivalence of test and reference product
Timeframe: Day 1 (0-24Hrs)
Demonstrate the therapeutic equivalence of test and reference product
Timeframe: Day 28 of treatment
Demonstrate the superiority of test and reference product over placebo
Timeframe: Day 1 (0-24 hours (Hrs)
Demonstrate the superiority of test and reference product over placebo
Timeframe: Day 28 of treatment