Evaluating the Efficacy and Safety of PT027 Compared With PT007 Administered As Needed in Partici… (NCT06307665) | Clinical Trial Compass
RecruitingPhase 3
Evaluating the Efficacy and Safety of PT027 Compared With PT007 Administered As Needed in Participants 12 to < 18 Years of Age With Asthma
United States, China, Mexico440 participantsStarted 2024-05-20
Plain-language summary
The purpose of this study is to compare the effect of budesonide/albuterol metered-dose inhaler (BDA MDI) with albuterol sulfate metered-dose inhaler (AS MDI), both administered as needed, on the annualized rate of severe asthma exacerbations in adolescents with a documented clinical diagnosis of asthma and at least one severe exacerbation in the prior year.
Who can participate
Age range
12 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
. Low-to-high-dose ICS or ICS/long-acting β2-agonist (LABA) with or without one additional maintenance therapy from the following: leukotriene receptor antagonist (LTRA), long-acting muscarinic antagonist (LAMA), or theophylline
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 3 trial comparing PT027 to PT007 as-needed inhalers in teenagers with asthma, what do we already know about how these two medications have performed in adults or earlier studies, and does that history make this a reasonable option to discuss for my teen?
2The trial is measuring the annual rate of severe asthma exacerbations as its main goal — given my child's current exacerbation history, would their asthma severity level likely be a good fit for what this study is trying to measure?
3Both PT027 and PT007 are used 'as needed' rather than as daily controller medications — how does that approach compare to the daily preventive inhaler my child might otherwise be prescribed, and is there a risk that as-needed-only treatment could leave their asthma less controlled?
4Since this trial is still actively recruiting, what would participation actually look like in terms of clinic visits, monitoring, and time commitment for a teenager who is in school?
5Are there standard-of-care treatment options already approved for teens with asthma that we should consider first before exploring enrollment in this trial, and how do those compare to what's being tested here?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Annualized rate of severe asthma exacerbations (AAER)
Timeframe: From Randomization (Day 1) to Week 52 (EOT)