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Evaluating the Efficacy and Safety of PT027 Compared With PT007 Administered As Needed in Participants 12 to < 18 Years of Age With Asthma

Testing PT027 vs. PT007 for asthma in teens.

Recruiting
12-17 years
All
Phase 3

The study aims to see how well two inhalers work for asthma in kids aged 12 to less than 18. It compares the budesonide/albuterol inhaler (BDA MDI) with the albuterol sulfate inhaler (AS MDI), both used when needed. Asthma is a condition where the airways in the lungs become narrow, making it hard to breathe. This study is for kids who have had a severe asthma attack in the last year.

There are three periods in the study: a screening period lasting 7 to 28 days, a treatment period of 52 weeks, and a safety follow-up period of 7 to 14 days. Participants will be randomly assigned to one of the inhalers and will continue their usual asthma treatment. There's also a special test (pharmacokinetic sub-study) after the main study to see how the medicine moves in the body.

  • Study lasts one year with regular check-ups.
  • Participants must have had at least one severe asthma attack in the past year.
  • Participants will receive free study inhalers.
Study details
    Asthma

NCT06307665

AstraZeneca

30 March 2025

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