PT027 vs PT007 for Asthma in Teens

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

Recruiting Phase 3 Interventional Study
Asthma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
12 – 17
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
440 (estimated)
Sponsor
AstraZeneca · Industry
Who this trial is looking for

This trial is looking for adolescents aged 12 to 17 with asthma. Participants will compare two treatments for asthma that are used when needed to see which is more effective and safe.

Are You a Good Fit for This Trial?
Rules you out Serious lung diseaseCancer not in remissionPsychiatric disorderSubstance abuse

You may be able to join if

  • I have been diagnosed with asthma for at least 12 months.
  • I have had at least one severe asthma attack in the past year.
  • I am currently receiving asthma maintenance therapy.
  • I use a rescue inhaler as needed.
  • I can take my medication correctly as verified by a doctor.
  • I can do expected lung function tests.
  • I can agree to participate in the study.
  • I have a negative pregnancy test if I can get pregnant.

You may not be able to join if

  • I have had a severe asthma episode that required intubation.
  • I have had more than 3 severe asthma attacks in the last year.
  • I have had a serious lung infection within the last 4 weeks.
  • I have not fully recovered from an upper respiratory infection.
  • I currently smoke or have smoked heavily in the past.
  • I have another serious lung disease.
  • I have a significant health issue like cancer or a psychiatric disorder.
  • I have taken oral steroids for asthma in the last month.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Confirmed clinical diagnosis of asthma at least 12 months. * Receiving one of the following scheduled asthma maintenance therapies for at least 3 months with stable dosing for at least the last one month 1. Low-to-high-dose Inhaled corticosteroid(s) (ICS) 2. Low-to-high-d…
Contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

CONTACT