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

NCT06471257
clinicaltrials.gov
Phase
Phase 3
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Recruitment status
Recruiting
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Participants
1,000
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Lead sponsor
AstraZeneca
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Start date
2024-06-17
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Number of sites
102
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Summary
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.
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Acronym
BAIYUN
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Short title
A Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma
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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)
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2027-10-04
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First posted
2024-06-24
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Registry last updated
2026-08-07
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Primary completion date
2027-10-04
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Start date
2024-06-17
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Participants
1,000
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Participant count basis
Estimated
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Planned participants
1,000
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Protocol amendments
1
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Randomisation ratio
1:1
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Number of sites
102
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Registry sponsor category
Industry
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Lead sponsor
AstraZeneca
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06471257
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ClinicalTrials.gov ID
NCT06471257
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

  1. Time to first severe asthma exacerbation

    Timeframe: 24 to 52 weeks

    The efficacy of BDA MDI administered as needed compared with AS MDI on severe asthma exacerbation risk over the 24 to 52 week treatment period.

  1. Severe asthma exacerbation rate (annualized)

    Timeframe: 24 to 52 weeks

    The efficacy of BDA MDI administered as needed compared with AS MDI on severe asthma exacerbations and SCS exposure

  2. Total SCS exposure over the treatment period

    Timeframe: 24 to 52 weeks

    The efficacy of BDA MDI administered as needed compared with AS MDI on severe asthma exacerbations and SCS exposure

  3. ACQ-5 responder (≥ 0.5 decrease)

    Timeframe: Week 24

    The effect of BDA MDI administered as needed compared with AS MDI on PROs at Week 24

  4. AQLQ+12 responder (≥ 0.5 increase)

    Timeframe: Week 24

    The effect of BDA MDI administered as needed compared with AS MDI on PROs at Week 24

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  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

  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
Sources for eligibility
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  • Research SiteBaotou, ChinaRecruiting
  • Research SiteBaotou, ChinaRecruiting
  • Research SiteBeijing, ChinaActive, not recruiting
  • Research SiteBeijing, ChinaRecruiting
  • Research SiteBeijing, ChinaRecruiting
  • Research SiteBeijing, ChinaRecruiting
  • Research SiteChangchun, ChinaRecruiting
  • Research SiteChangchun, ChinaRecruiting
  • Research SiteChangsha, ChinaRecruiting
  • Research SiteChangsha, ChinaRecruiting
  • Research SiteChengdu, ChinaRecruiting
  • Research SiteChengdu, ChinaRecruiting
  • Research SiteChengdu, ChinaRecruiting
  • Research SiteChengdu, ChinaRecruiting
  • Research SiteChengdu, ChinaRecruiting
  • Research SiteChizhou, ChinaRecruiting
  • Research SiteChongqing, ChinaRecruiting
  • Research SiteChongqing, ChinaRecruiting
  • Research SiteChongqing, ChinaCompleted
  • Research SiteDazhou, ChinaRecruiting
  • Research SiteDeyang, ChinaRecruiting
  • Research SiteGanzhou, ChinaRecruiting
  • Research SiteGuangyuan, ChinaRecruiting
  • Research SiteGuangzhou, ChinaActive, not recruiting
  • Research SiteGuangzhou, ChinaRecruiting

And 77 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Related records

Drugs (2)

Lead sponsors (1)

Conditions (1)

Targets (2)