Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2025-12-25 @ 1:28 AM
NCT ID:
NCT07223294
Brief 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.
Study:
NCT07223294
Study Brief:
Protocol Section:
NCT07223294