NCT06307665招募中3 期
A Randomized, Double-blind, Multicenter, Parallel-group, Phase IIIb 52 Week Study Evaluating the Efficacy and Safety of PT027 Compared With PT007 Administered as Needed in Participants 12 to < 18 Years of Age With Asthma (ACADIA)
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 440
- 试验地点
- 150
- 主要终点
- Annualized rate of severe asthma exacerbations (AAER)
研究概览
简要总结
The purpose of this study is to compare the effect of budesonide/albuterol metered-dose inhaler (BDA MDI) with albuterol sulfate metered-dose inhaler (AS MDI), both administered as needed, on the annualized rate of severe asthma exacerbations in adolescents with a documented clinical diagnosis of asthma and at least one severe exacerbation in the prior year.
详细描述
This is a randomized, double-blind, multicenter, parallel-group Phase IIIb study with a fixed treatment period of 52 weeks.
The study will consist of 3 periods:
- Screening period (7 to 28 days)
- Treatment period of 52 weeks
- Safety follow-up period (7 to 14 days after the end of treatment [EOT] visit)
Participants who meet the eligibility criteria will be randomly assigned to BDA MDI 160/180 micrograms (μg) or AS MDI 180 μg treatment groups in a 1:1 ratio on top of their own usual maintenance therapy during treatment period.
This study will also include a pharmacokinetic (PK) sub-study with single visit scheduled after the safety follow-up visit in the main study. During PK sub-study, single dose of open-label BDA MDI 160/180 μg will be administered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed clinical diagnosis of asthma at least 12 months.
- •Receiving one of the following scheduled asthma maintenance therapies for at least 3 months with stable dosing for at least the last one month
- •Low-to-high-dose Inhaled corticosteroid(s) (ICS)
- •Low-to-high-dose ICS or ICS/long-acting β2-agonist (LABA) with or without one additional maintenance therapy from the following: leukotriene receptor antagonist (LTRA), long-acting muscarinic antagonist (LAMA), or theophylline
- •Receiving inhaled short-acting β2-agonist (SABA) as needed.
- •A documented history of at least one severe asthma exacerbation within 12 months.
- •Use of Sponsor-provided albuterol sulfate inhalation aerosol medication.
- •Demonstrate acceptable MDI administration technique as assessed by the investigator; use of spacers is prohibited.
- •Able to perform acceptable and reproducible peak expiratory flow (PEF) measurements as assessed by the investigator.
- •Participants must adhere to protocol specific contraception methods.
- •Negative urine pregnancy test for participants of childbearing potential.
- •Have a BMI < 40 kg/ m^
- •Capable of giving assent (signing the assent form) to participate in the study which includes compliance with the requirements and restrictions. The caregiver of the patient must be capable of giving written informed consent for the patient's participation in the study. Consent and assent forms must be completed prior to any study-specific procedures.
排除标准
- •Life-threatening asthma defined as any history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s).
- •Experienced > 3 severe asthma exacerbations within 12 months before screening.
- •Completed treatment for lower respiratory infection and severe asthma exacerbation with SCS within 4 weeks of screening.
- •Upper respiratory infection involving antibiotic treatment not resolved.
- •Current smokers, former smokers with > 10 pack-years history, or former smokers who stopped smoking < 6 months (including all forms of tobacco, e-cigarettes [vaping], and marijuana).
- •Other significant lung disease, including regular or occasional use of oxygen.
- •Historical or current evidence of a clinically significant disease including, but not limited to: cardiovascular, hepatic, renal, hematological, neuropsychological, endocrine, or gastrointestinal disorders.
- •Cancer not in complete remission for at least 5 years.
- •History or hospitalization for psychiatric disorder or attempted suicide within one year.
- •Significant abuse of alcohol or drugs, in the opinion of the investigator.
- •Oral corticosteroid(s) (OCS)/SCS use (any dose and any indication) within 4 weeks before Visit 1 or chronic use of OCS/SCS (≥ 3 weeks use in 3 months prior to Visit 1).
- •Use of any oral SABAs within one month.
- •Having a known or suspected hypersensitivity to albuterol/salbutamol, or budesonide and/or their excipients.
研究组 & 干预措施
Budesonide/albuterol metered -dose inhaler (BDA MDI)
Experimental
Participants will receive BDA MDI 160/180 μg (given as 2 puffs of 80/90 μg) as needed.
干预措施: BDA MDI (Combination Product)
Albuterol sulfate metered-dose inhaler (AS MDI)
Active Comparator
Participants will receive AS MDI 180 μg (given as 2 puffs of 90 μg) as needed.
干预措施: AS MDI (Combination Product)
结局指标
主要结局
Annualized rate of severe asthma exacerbations (AAER)
时间窗: From Randomization (Day 1) to Week 52 (EOT)
The effect of BDA MDI compared with AS MDI, both administered as needed, on the AAER in participants with asthma will be evaluated.
次要结局
- Apparent volume of distribution based on the terminal phase (Vz/F)(At 0, 10, 20, 40 minutes and 1, 2, 4, 6, 8, 10, and 12 hours post-dose)
- Time to reach maximum concentration following drug administration (Tmax)(At 0, 10, 20, 40 minutes and 1, 2, 4, 6, 8, 10, and 12 hours post-dose)
- Area under concentration-time curve from time 0 to infinity (AUCinf)(At 0, 10, 20, 40 minutes and 1, 2, 4, 6, 8, 10, and 12 hours post-dose)
- Time of last quantifiable concentration (Tlast)(At 0, 10, 20, 40 minutes and 1, 2, 4, 6, 8, 10, and 12 hours post-dose)
- Terminal elimination half-life (t½λz)(At 0, 10, 20, 40 minutes and 1, 2, 4, 6, 8, 10, and 12 hours post-dose)
- Number of participants with adverse events (AEs) and severe adverse events (SAEs)(Up to Week 52)
- Terminal elimination rate constant (λz)(At 0, 10, 20, 40 minutes and 1, 2, 4, 6, 8, 10, and 12 hours post-dose)
- Annualized total systemic corticosteroids (SCS) exposure for treatment of asthma(From Randomization (Day 1) to Week 52 (EOT))
- Time to first (TTF) severe asthma exacerbation(From Randomization (Day 1) to Week 52 (EOT))
- Maximum Observed Concentration (Cmax)(At 0, 10, 20, 40 minutes and 1, 2, 4, 6, 8, 10, and 12 hours post-dose)
- Area under concentration-time curve from time 0 to last quantifiable concentration (AUClast)(At 0, 10, 20, 40 minutes and 1, 2, 4, 6, 8, 10, and 12 hours post-dose)
- Apparent total body clearance (CL/F)(At 0, 10, 20, 40 minutes and 1, 2, 4, 6, 8, 10, and 12 hours post-dose)
研究者
研究点 (150)
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