What is PT027 studying for asthma?

PT027 is being studied to see if it can reduce the risk of severe asthma attacks in symptomatic Chinese adults. The trial compares PT027 with another inhaler called PT007 to evaluate their safety and effectiveness. AstraZeneca is leading this research to help improve asthma treatment options.

Who may be eligible for this asthma clinical trial?

Adults aged 18 years or older with a diagnosis of asthma for at least one year may be eligible. Participants must have used inhaled maintenance therapy with stable dosing and have experienced at least one severe asthma attack in the past year. Both men and women can join, but women of childbearing potential must agree to use contraception. Please review eligibility criteria for more details.

Is there any cost to participate in this asthma clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for their travel needs.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID06471257

Phase III Study Comparing BudesonideAlbuterol MDI and Albuterol Sulfate MDI for Symptomatic Chinese Adults With Asthma Evaluating Safety and Effectiveness as Needed Treatment

Led by AstraZeneca · Updated on 2026-08-07

1000

Participants Needed

102

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the efficacy and safety of two inhalers, BDA MDI budesonide and albuterol and AS MDI albuterol sulfate, in reducing severe asthma attacks among symptomatic Chinese adults with asthma. This Phase III, randomized, double-blind, multicenter study involves about 1000 participants who have been diagnosed with asthma and continue to experience symptoms despite maintenance therapy. Participants will be randomly assigned to receive either BDA MDI 160180 mcg two puffs of 8090 mcg or AS MDI 180 mcg two puffs of 90 mcg as needed to relieve asthma symptoms or before exercise. The study includes a screening period lasting 14 to 28 days, followed by a treatment period of at least 24 weeks and up to 52 weeks, and concludes with a safety follow-up about two weeks after the last treatment visit. During the trial, participants will attend regular visits to monitor their asthma control and lung function. Researchers will assess the time to the first severe asthma exacerbation, the rate of exacerbations, steroid use, and responses to asthma control questionnaires. Safety will be carefully followed during and after treatment, with the total participation lasting up to approximately one year.

CONDITIONS

Brief Title

A Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Documented physician-diagnosed asthma for at least 12 months prior to Visit 1
Receiving scheduled asthma maintenance therapy for 3 months with stable dosing for at least 4 weeks before Visit 1
Pre-bronchodilator FEV1 between 40% and less than 90% of predicted normal value
Documented reversibility to albuterol
History of at least one severe asthma exacerbation within 12 months before Visit 1
ACQ-7 score of 1.5 or higher at Visit 1
ACQ-5 score of 1.5 or higher at Visit 2
Use of inhaled short-acting beta-agonists as needed for at least 3 months prior to Visit 1
Use of sponsor-provided salbutamol inhaler on at least 3 days during the last week before Visit 2
Ability to correctly use metered dose inhaler without spacer
Ability to perform acceptable and reproducible peak expiratory flow measurements
Body mass index less than 40 kg/m2
Negative urine pregnancy test at Visit 1 for women of childbearing potential
Women of childbearing potential must agree to prevent pregnancy
Willingness to remain at study site as required and complete all visit assessments

You will not qualify if you...

Chronic obstructive pulmonary disease or other significant lung diseases
Use of oral or systemic corticosteroids within 6 weeks before Visit 1
Chronic use of oral corticosteroids for 3 weeks or more in the 3 months before Visit 1
Use of any biologic medication within 3 months or 5 half-lives before Visit 1, or other prohibited medications
Current smokers, former smokers with more than 10 pack-years, or those who stopped smoking less than 6 months before Visit 1
History of life-threatening asthma events in the past 5 years
Recent treatment for lower respiratory infection or asthma exacerbation within 6 weeks of Visit 1
Upper respiratory infection requiring antibiotics not resolved within 7 days before Visit 1
Clinically significant laboratory abnormalities
History or current evidence of significant disease
Cancer not in complete remission for at least 5 years before Visit 1
Psychiatric illness, intellectual deficiency, or poor motivation limiting informed consent
Known or suspected allergy to study medications or their ingredients
Inability to avoid prohibited medications during the study
Receipt of live attenuated vaccine within 7 days before Visit 1
Currently pregnant or breastfeeding
More than one asthma exacerbation during the screening period

Research Team

AstraZeneca Clinical Study Information Center

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Phase III Study Comparing BudesonideAlbuterol MDI and Albuterol Sulfate MDI for Symptomatic Chinese Adults With Asthma Evaluating Safety and Effectiveness as Needed Treatment

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria