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

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)

Overview

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.

Detailed description

This is a randomized, double-blind, multicenter, event-driven, parallel group, Phase III study to assess the efficacy and safety of budesonide and albuterol metered dose inhaler (MDI) versus albuterol sulfate (AS) MDI in symptomatic Chinese adults with asthma. Both treatments will be administered as needed in response to asthma symptoms or prior to exercise. Approximately 1000 participants who meet the eligibility criteria will be randomized.

The study will consist of 3 periods:

1. Screening period: 14 to 28 days 2. Treatment period: minimum of 24 weeks and maximum of 52 weeks 3. Safety follow-up period: occur 2 weeks (± 4 days) after Visit 8, EOS or PDV, whichever occurs first

1000 participants who meet the eligibility criteria will be randomly assigned in a 1:1 ratio to receive one of the following 2 treatments to be used as reliever therapy on top of usual maintenance treatment:

* BDA MDI 160/180 μg (administered as 2 actuations of BDA MDI 80/90 µg) as needed * AS MDI 180 μg (administered as 2 actuations of AS MDI 90 μg) as needed

Interventions

• Combination product Budesonide/Albuterol metered dose inhaler, MDI
  Combination Product (Drug + Device)
• Combination product Albuterol sulfate metered dose inhaler, MDI
  Combination Product (Drug + Device)

Primary outcome measures

• Time to first severe asthma exacerbation [Time frame: 24 to 52 weeks]

Secondary outcome measures (4)

• Severe asthma exacerbation rate (annualized) [Time frame: 24 to 52 weeks]
• Total SCS exposure over the treatment period [Time frame: 24 to 52 weeks]
• ACQ-5 responder (≥ 0.5 decrease) [Time frame: Week 24]
• AQLQ+12 responder (≥ 0.5 increase) [Time frame: Week 24]

Eligibility criteria

Inclusion criteria

• Documented physician-diagnosed asthma for at least 12 months prior to Visit 1
• Receiving 1 of the scheduled asthma maintenance therapies for 3 months with stable dosing for at least the last 4 weeks before Visit 1
• Pre-bronchodilator FEV1 of ≥ 40% to < 90% predicted normal value for adults.
• Documented reversibility to albuterol
• A documented history of at least one severe asthma exacerbation within 12 months before Visit 1
• ACQ-7 score ≥ 1.5 assessed at Visit 1
• ACQ-5 score ≥ 1.5 assessed at Visit 2
• Receiving inhaled SABA as needed prior to Visit 1 for at least 3 months
• 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
• Demonstrate acceptable MDI administration technique as assessed by the investigator; use of spacers is prohibited
• Able to perform acceptable and reproducible PEF measurements as assessed by the investigator
• BMI < 40 kg/m2
• Negative pregnancy test (urine at Visit 1) for female participants of childbearing potential
• Women of childbearing potential must agree to prevent pregnancy
• Compliance: must be willing to remain at the study site as required per protocol and complete all visit assessments

Exclusion criteria

• Chronic obstructive pulmonary disease or other significant lung disease
• Oral/SCS use (any dose) within 6 weeks before Visit 1
• Chronic use of OCS ≥ 3 weeks use in 3 months prior to Visit 1
• 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
• Current smokers, former smokers with > 10 pack-years history, or former smokers who stopped smoking < 6 months before Visit 1
• 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
• Completed treatment for lower respiratory infection or asthma exacerbation within 6 weeks of Visit 1
• Upper respiratory infection involving antibiotic treatment not resolved within 7 days before Visit 1
• Clinically significant laboratory abnormalities
• Historical or current evidence of a clinically significant disease
• Cancer not in complete remission for at least 5 years before Visit 1
• History of psychiatric disease, intellectual deficiency, poor motivation, or other conditions if their magnitude is limiting informed consent validity
• Have a known or suspected hypersensitivity to albuterol/salbutamol, or budesonide and/or their excipients
• Inability to abstain from protocol-defined prohibited medications during the study
• Having received a live attenuated vaccination within 7 days of Visit 1
• Currently pregnant or breastfeeding
• Participants who experience > 1 asthma exacerbation during the screening period

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

China · 101 centers

• Research Site — Baotou
• Research Site — Baotou
• Research Site — Beijing
• Research Site — Beijing
• Research Site — Beijing
• Research Site — Beijing
• Research Site — Changchun
• Research Site — Changchun
• … and 93 more centers

Hong Kong · 1 center

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06471257 · D6935C00003

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗