A Randomized, Double-Blind, Double-Dummy, Placebo Controlled, Parallel-Group, 12-Week Clinical Study to Assess the Efficacy and Safety of 320 or 640 mcg/Day of Beclomethasone Dipropionate Delivered Via Breath-Actuated Inhaler (BAI) or Metered-Dose Inhaler (MDI) in Adolescent and Adult Patients 12 Years of Age and Older With Persistent Asthma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,113
- 试验地点
- 131
- 主要终点
- Standardized Baseline-adjusted Trough Morning Forced Expiratory Volume in 1 Second (FEV1) Area Under the Effect Curve From Time 0 to 12 Weeks (AUEC(0-12wk) )
研究概览
简要总结
This is a Phase 3, randomized, placebo-controlled, double-blind,double-dummy, parallel-group, 12-week study in male and female patients, 12 years of age and older, with persistent asthma.
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 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severity of disease: The patient has persistent asthma, with a forced expiratory volume in 1 second (FEV1) 40%-85% of the value predicted for age, height, sex, and race as per the National Health and Nutrition Examination Survey (NHANES III) (Hankinson et al 1999) reference values at screening visit.
- •Current asthma therapy: The patient must be on a stable dose of an inhaled corticosteroid (ICS) of at least 440 mcg/day of fluticasone propionate or equivalent for a minimum of 4 weeks before screening visit, or any inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) combination for a minimum of 4 weeks before the prescreening visit.
- •Reversibility of disease: The patient has demonstrated at least 12% reversibility of FEV1 and at least 200 mL increase from baseline FEV1 (patients age 18 and older) within 30 minutes after 2-4 inhalations of albuterol/salbutamol hydrofluoroalkane (HFA) MDI (90 mcg ex-actuator) or equivalent at the screening visit
- •If female, the patient is currently not pregnant, breast feeding, or attempting to become pregnant. If of childbearing potential, has a negative serum pregnancy test and is willing to commit to using a consistent and acceptable method of birth control.
- •Other criteria apply, please contact the investigator for more information
排除标准
- •The patient has a history of life-threatening asthma, defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest, or hypoxic seizures.
- •The patient is pregnant or lactating, or plans to become pregnant during the study period or for 30 days after the patient's last study-related visit (for eligible patients only, if applicable). Eligible female patients unwilling to employ appropriate contraceptive measures to ensure that pregnancy will not occur during the study will be excluded. Any patient becoming pregnant during the study will be withdrawn from the study.
- •The patient has a known hypersensitivity to any corticosteroid or any of the excipients in the study drug or rescue medication formulation.
- •The patient currently smokes or has a smoking history of 10 pack-years or more (a pack-year is defined as smoking 1 pack of cigarettes/day for 1 year).
- •The patient has had an asthma exacerbation requiring oral corticosteroids within 30 days before the screening visit, or has had any hospitalization for asthma within 2 months before the screening visit.
- •The patient has historical or current evidence of a clinically significant disease. Significant disease is defined as any disease that in the medical judgment of the investigator would put the safety of the patient at risk through participation or that could affect the efficacy or safety analysis if the disease/condition worsened during the study.
- •Other criteria apply, please contact the investigator for more information
研究组 & 干预措施
BDP 320 mcg BAI
Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.
干预措施: Beclomethasone dipropionate (Drug)
BDP 320 mcg BAI
Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.
干预措施: Placebo (Drug)
BDP 320 mcg BAI
Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.
干预措施: Albuterol/salbutamol (Drug)
BDP 640 mcg BAI
Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.
干预措施: Beclomethasone dipropionate (Drug)
BDP 640 mcg BAI
Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.
干预措施: Placebo (Drug)
BDP 640 mcg BAI
Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.
干预措施: Albuterol/salbutamol (Drug)
BDP 320 mcg MDI
Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily.
干预措施: Beclomethasone dipropionate (Drug)
BDP 320 mcg MDI
Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily.
干预措施: Placebo (Drug)
BDP 320 mcg MDI
Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily.
干预措施: Albuterol/salbutamol (Drug)
BDP 640 mcg MDI
Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily.
干预措施: Beclomethasone dipropionate (Drug)
BDP 640 mcg MDI
Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily.
干预措施: Placebo (Drug)
BDP 640 mcg MDI
Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily.
干预措施: Albuterol/salbutamol (Drug)
Placebo BAI and MDI
Placebo breath-actuated inhaler (BAI), twice daily. Plus placebo metered dose inhaler (MDI), twice daily.
干预措施: Placebo (Drug)
Placebo BAI and MDI
Placebo breath-actuated inhaler (BAI), twice daily. Plus placebo metered dose inhaler (MDI), twice daily.
干预措施: Albuterol/salbutamol (Drug)
结局指标
主要结局
Standardized Baseline-adjusted Trough Morning Forced Expiratory Volume in 1 Second (FEV1) Area Under the Effect Curve From Time 0 to 12 Weeks (AUEC(0-12wk) )
时间窗: Day 1 (baseline), Weeks 2, 4, 8, 12
Trough morning FEV1 measurements were taken pre-dose and pre-rescue bronchodilator treatment for asthma. The baseline pulmonary function measurement was defined as the measurement obtained at randomization visit (Day 1). Pulmonary function measurements (including FEV1) were obtained electronically by spirometry. All pulmonary function test data were submitted to a central reading center for evaluation. The highest FEV1 value from 3 acceptable and 2 repeatable maneuvers (maximum of 5 attempts) was used. Baseline-adjusted FEV1 AUEC(0-12wk) were calculated using the trapezoidal rule. The standardized baseline-adjusted FEV1 AUEC(0-12 wk) accommodates participants who dropped out of the study. Baseline-adjusted FEV1 AUEC(0-t weeks)/t, where t =12 weeks for patients who complete the FEV1 assessment at Week 12. For participants who dropped out early, t \<12 weeks (2, 4, or 8 weeks).
次要结局
- Change From Baseline in Weekly Average of Daily Trough Morning Peak Expiratory Flow (PEF) Over the 12-week Treatment Period Using a Mixed Model for Repeated Measures (MMRM)(Baseline: Days -6 to Day 1 (pre-randomization), Treatment: Day 2 to Week 12)
- Change From Baseline in Weekly Average of Daily Evening Peak Expiratory Flow (PEF) Over the 12-week Treatment Period Using a Mixed Model for Repeated Measures (MMRM)(Baseline: Days -7 to Day -1, Treatment: Day 1 to Week 12)
- Change From Baseline in the Weekly Average of Total Daily (24-hour) Use of Albuterol/Salbutamol Inhalation Aerosol (Number of Inhalations) Over Weeks 1-12 Using a Mixed Model for Repeated Measures (MMRM)(Baseline: Days -6 to Day 1 (pre-randomization), Treatment: Day 1 to Week 12)
- Change From Baseline in the Weekly Average of the Total Daily Asthma Symptom Score Over Weeks 1-12 Using a Mixed Model for Repeated Measures (MMRM)(Days -6 to Day 1 (pre-randomization), Treatment: Day 1 to Week 12)
- Kaplan-Meier Estimates for Time to Withdrawal From Study Treatment Due to Meeting Stopping Criteria for Worsening Asthma(Day 1 - Week 12)
- Number of Participants Withdrawn From Study Due to Meeting Stopping Criteria for Worsening Asthma During the 12-Week Treatment Period(Treatment period: Day 1 up to Week 12)