PT027 vs PT007 for Asthma in Chinese Adults

A Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults 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
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
1,000 (estimated)
Sponsor
AstraZeneca · Industry
Who this trial is looking for

This trial is looking for Chinese adults with asthma who have experienced severe asthma symptoms. Participants will be given one of two inhalers to see how effective they are at reducing asthma attacks.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have been diagnosed with asthma for at least 12 months.
  • I have been on asthma maintenance therapy for 3 months.
  • I have had at least one severe asthma attack in the last year.
  • I have a specific score indicating my asthma symptoms.
  • I use a rescue inhaler for my asthma symptoms.
  • I am able to take measurements of my lung function.
  • I am willing to stay at the study site for assessments.
  • I am a woman of childbearing potential and agree to prevent pregnancy.

You may not be able to join if

  • I have chronic obstructive pulmonary disease or other serious lung disease.
  • I have used oral steroids in the last 6 weeks.
  • I am a current smoker or recently stopped smoking.
  • I have had a serious asthma event requiring intensive care in the last 5 years.
  • I have had an unresolved respiratory infection within a week of Visit 1.
  • I am currently pregnant or breastfeeding.
  • I have a known allergy to albuterol or budesonide.
  • I have had more than one asthma attack during the screening period.

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

An event-driven, Phase III study to evaluate the efficacy and safety of BDA MDI compared with AS MDI in reducing the risk of a severe asthma exacerbation in symptomatic Chinese adults with asthma.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Documented physician-diagnosed asthma for at least 12 months prior to Visit 1 2. Receiving 1 of the scheduled asthma maintenance therapies for 3 months with stable dosing for at least the last 4 weeks before Visit 1 3. Pre-bronchodilator FEV1 of ≥ 40% to \< 90% predicted norm…
Contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

CONTACT