A study to investigate efficacy and safety of PT027 compared with PT007 in symptomatic Chinese adults with asthma - BAIYUN

Study identifier:D6935C00003

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Will Be Recruiting

Official Title

A Randomized, Double-blind, Multicentre, Event-driven, Parallel group, Phase III Study Evaluating the Efficacy and Safety of PT027 Compared with PT007 Administered As Needed in Symptomatic Chinese Adults with Asthma (BAIYUN)

Medical condition

asthma

Phase

Phase 3

Healthy volunteers

Study drug

Budesonide/Albuterol metered dose inhaler, MDI, Albuterol sulfate metered dose inhaler, MDI

Sex

All

Estimated Enrollment

790

Study type

Interventional

Age

18 Years - n/a

Date

Study Start Date: 30 Jul 2024

Estimated Primary Completion Date: 30 Oct 2026

Estimated Study Completion Date: 30 Oct 2026

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Jun 2024 by AstraZeneca

Collaborators

Inclusion and exclusion 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 normal value for adults.
4. Documented reversibility to albuterol
5. A documented history of at least one severe asthma exacerbation within 12 months before Visit 1
6. ACQ-7 score ≥ 1.5 assessed at Visit 1
7. ACQ-5 score ≥ 1.5 assessed at Visit 2
8. Receiving inhaled SABA as needed prior to Visit 1 for at least 3 months
9. Use of Sponsor-provided salbutamol sulfate inhalation aerosol as needed medication due to asthma symptoms on at least 3 days during the last week of the run-in period before Visit 2
10. Demonstrate acceptable MDI administration technique as assessed by the investigator; use of spacers is prohibited
11. Able to perform acceptable and reproducible PEF measurements as assessed by the investigator
12. BMI < 40 kg/m2
13. Negative pregnancy test (urine at Visit 1) for female participants of childbearing potential
14. Women of childbearing potential must agree to prevent pregnancy
15. Compliance: must be willing to remain at the study site as required per protocol and complete all visit assessments

Exclusion Criteria

1. Chronic obstructive pulmonary disease or other significant lung disease
2. Oral/SCS use (any dose) within 6 weeks before Visit 1
3. Chronic use of OCS ≥ 3 weeks use in 3 months prior to Visit 1
4. Having received any marketed or investigational biologic within 3 months or 5 half-lives before Visit 1, whichever is longer, or any other prohibited medication
5. Current smokers, former smokers with > 10 pack-years history, or former smokers who stopped smoking < 6 months before Visit 1
6. Life-threatening asthma as defined as any history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma related syncopal episode(s) within last 5 years of Visit 1
7. Completed treatment for lower respiratory infection or asthma exacerbation within 6 weeks of Visit 1
8. Upper respiratory infection involving antibiotic treatment not resolved within 7 days before Visit 1
9. Clinically significant laboratory abnormalities
10.Historical or current evidence of a clinically significant disease
11. Cancer not in complete remission for at least 5 years before Visit 1
12. History of psychiatric disease, intellectual deficiency, poor motivation, or other conditions if their magnitude is limiting informed consent validity
13. Have a known or suspected hypersensitivity to albuterol/salbutamol, or budesonide and/or their excipients
14. Inability to abstain from protocol-defined prohibited medications during the study
15. Having received a live attenuated vaccination within 7 days of Visit 1
16. Currently pregnant or breastfeeding
17. Participants who experience > 1 asthma exacerbation during the screening period

No locations available

Arms	Assigned Interventions
Experimental: BDA MDI BDA MDI 160/180 μg (administered as 2 actuations of BDA MDI 80/90 μg)	Combination Product: Budesonide/Albuterol metered dose inhaler, MDI Combination Product (Drug + Device) Other Name: PT027
Active Comparator: AS MDI AS MDI 180 μg (administered as 2 actuations of AS MDI 90 μg)	Combination Product: Albuterol sulfate metered dose inhaler, MDI Combination Product (Drug + Device) Other Name: PT007

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]