NCT01704495已完成2 期
A 6-month, Randomised, Double-blind, Placebo-controlled, Multi-centre, Parallel-group, Phase II Study With an Optional Safety Extension Treatment Period up to 6 Months, to Evaluate the Efficacy, Safety, and Tolerability of 3 Different Doses of AZD5069 Twice Daily as Add-on Treatment to Medium to High Dose Inhaled Corticosteroids (ICS) and Long-acting β2 Agonists (LABA), in Patients With Uncontrolled Persistent Asthma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 1,147
- 试验地点
- 1
- 主要终点
- Rate of Severe Asthma Exacerbations During 6 Months
研究概览
简要总结
The purpose is to Evaluate the Efficacy, Safety, and Tolerability of 3 Different Doses of AZD5069 Twice Daily as Add-on Treatment to Medium to High Dose Inhaled Corticosteroids (ICS) and Long-acting β2 Agonists (LABA), in Patients with Uncontrolled Persistent Asthma
详细描述
A 6-month, Randomised, Double-blind, Placebo-controlled, Multi-centre, Parallel-group, Phase II Study with an Optional Safety Extension Treatment Period up to 6 months, to Evaluate the Efficacy, Safety, and Tolerability of 3 Different Doses of AZD5069 Twice Daily as Add-on Treatment to Medium to High Dose Inhaled Corticosteroids (ICS) and Long-acting β2 Agonists (LABA), in Patients with Uncontrolled 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 150 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 18 years and above. Females of childbearing potential must use a highly effective contraceptive method plus a condom by their male partner.
- •Diagnosis of asthma for at least 12 months (GINA 2011)
- •Uncontrolled persistent asthma, despite treatment with medium to high dose ICS and LABA, and with a history of exacerbations during the last year
- •Morning prebronchodilator FEV1 of ≥30% and ≤85% predicted normal at enrolment
- •Daily use of medium or high dose ICS (≥fluticasone 500 µg or the equivalent daily)
排除标准
- •Any clinically significant disease or disorder (including any chronic lower respiratory disease other than asthma) that may put the patient at risk or influence study results
- •Patients with recurrent, latent, or chronic infections
- •Active tuberculosis or latent tuberculosis without completion of an appropriate course of treatment or prophylactic treatment
- •Significant lower respiratory tract infection not resolved within 30 days prior to enrolment
- •Current smoker or smoking history of more than 20 pack years
研究组 & 干预措施
AZD5069 45 mg
Experimental
AZD5069 oral capsules self-administered twice daily
干预措施: AZD5069 (Drug)
AZD5069 5 mg
Experimental
AZD5069 oral capsules self-administered twice daily
干预措施: AZD5069 (Drug)
AZD5069 15 mg
Experimental
AZD5069 oral capsules self-administered twice daily
干预措施: AZD5069 (Drug)
Placebo
Placebo Comparator
Placebo oral capsules self-administered twice daily
干预措施: Placebo (Drug)
结局指标
主要结局
Rate of Severe Asthma Exacerbations During 6 Months
时间窗: From start of treatment up to 6 months
次要结局
- Rate of Asthma-specific Hospital Admission/Intensive Care Unit Admissions During 6 Months(From start of treatment up to 6 months)
- Total Number of Days on Oral Cortecosteroids, Due to a Worsening of Asthma Symptoms(From start of treatment up to 6 months)
- Change From Baseline to 1 Month Measurement of Pre-bronchodilator FEV1(Baseline (Day 0) and 1 month after Day 0)
- Change From Baseline to Overall Mean of Treatment Period in AQLQ(S) (Asthma Quality of Life Questionnaire Standardised Version) Overall Score(Baseline (Day 0), Treatment Period (1,3, and 6 months))
- Change From Baseline to Treatment Period (Day 1 to Day 28) for Astma Symptom Free Days(Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28))
- Change From Baseline to Treatment Period (Day 29 to Day 56) for Astma Symptom Free Days(Baseline (last 14 days before randomization) and Treatment Period (Days 29 to 56))
- Change From Baseline to Treatment Period (Day 1 to Day 28) for Asthma Control Days(Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28))
- Change From Baseline to Treatment Period (Day 1 to Day 28) for Night Time Awakenings Due to Asthma Symptoms(Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28))
- Total Number of Days of Asthma-specific Hospital Admission/Intensive Care Unit Admissions(From start of treatment up to 6 months)
- Change From Baseline to 2 Weeks Measurement of Pre-bronchodilator FEV1(Baseline (Day 0) and 2 weeks after Day 0)
- Change From Baseline to 2 Months Measurement of Pre-bronchodilator FEV1(Baseline (Day 0) and 2 months after Day 0)
- Change From Baseline to 3 Months Measurement of Pre-bronchodilator FEV1(Baseline (Day 0) and 3 months after Day 0)
- Change From Baseline to 4 Months Measurement of Pre-bronchodilator FEV1(Baseline (Day 0) and 4 months after Day 0)
- Change From Baseline to 6 Months Measurement of Pre-bronchodilator FEV1(Baseline (Day 0) and 6 months after Day 0)
- Change From Baseline to 2 Weeks Measurement of Post-bronchodilator FEV1(Baseline (Day 0) and 2 weeks after Day 0)
- Change From Baseline to 2 Months Measurement of Post-bronchodilator FEV1(Baseline (Day 0) and 2 months after Day 0)
- Change From Baseline to 3 Months Measurement of Post-bronchodilator FEV1(Baseline (Day 0) and 3 months after Day 0)
- Change From Baseline to 4 Months Measurement of Post-bronchodilator FEV1(Baseline (Day 0) and 4 months after Day 0)
- Change From Baseline to 6 Months Measurement of Post-bronchodilator FEV1(Baseline (Day 0) and 6 months after Day 0)
- Change From Baseline to 1 Month Measurement of Post-bronchodilator FEV1(Baseline (Day 0) and 1 month after Day 0)
- Change From Baseline to Overall Mean of Treatment Period in ACQ-5 (Asthma Control Questionnaire, 5-item Version) Total Score(Baseline (Day 0), Treatment Period (1,2,3,4, and 6 months))
- Number of Patients Presenting Improvement From Baseline to End of Treatment Period in ACQ-5 (Asthma Control Questionnaire, 5-item Version)(Baseline (Day 0) and 6 months after Day 0)
- Number of Patients Presenting Improvement From Baseline to End of Treatment Period in AQLQ(S) (Asthma Quality of Life Questionnaire Standardised Version) Overall Score(Baseline (Day 0) and 6 months after Day 0)
- Change From Baseline to Treatment Period (Day 29 to Day 56) for Asthma Control Days(Baseline (last 14 days before randomization) and Treatment Period (Days 29 to 56))
- Change From Baseline to Treatment Period (Day 57 to Day 84) for Asthma Control Days(Baseline (last 14 days before randomization) and Treatment Period (Days 57 to 84))
- Change From Baseline to Treatment Period (Day 57 to Day 84) for Asthma Symptom Free Days(Baseline (last 14 days before randomization) and Treatment Period (Days 57 to 84))
- Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Asthma Symptom Free Days(Baseline (last 14 days before randomization) and Treatment Period (Day 85 to 6 months))
- Change From Baseline to Treatment Period (Day 29 to Day 56) for Use of Rescue Medication Free Days(Baseline (last 14 days before randomization) and Treatment Period (Days 29 to 56))
- Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Asthma Control Days(Baseline (last 14 days before randomization) and Treatment Period (Days 85 to 6 months)
- Change From Baseline to Treatment Period (Day 57 to Day 84) for Use of Rescue Medication Free Days(Baseline (last 14 days before randomization) and Treatment Period (Days 57 to 84))
- Number of Well Controlled Asthma Weeks During Treatment(Day 1to end of the 6 months treatment period)
- Number of Uncontrolled Persistent Asthma Weeks During Treatment(Day 1 to end of the 6 months treatment period)
- Mean Plasma Concentration of AZD5069 at Day 7(Day 7)
- Mean Plasma Concentration of AZD5069 at 1 Month(at 1 month)
- Change From Baseline to Treatment Period (Day 1 to Day 28) for Use of Rescue Medication Free Days(Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28))
- Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Use of Rescue Medication Free Days(Baseline (last 14 days before randomization) and Treatment Period (Days 85 to 6 months))
- Change From Baseline to Treatment Period (Day 57 to Day 84) for Night Time Awakenings Due to Asthma Symptoms(Baseline (last 14 days before randomization) and Treatment Period (Day 57 to Day 84))
- Number of Participants With Uncontrolled Persistent Asthma Weeks at Baseline(Last 2 weeks before randomization)
- Change From Baseline to Treatment Period (Day 29 to Day 56) for Night Time Awakenings Due to Asthma Symptoms(Baseline (last 14 days before randomization) and Treatment Period (Day 29 to Day 56))
- Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Night Time Awakenings Due to Asthma Symptoms(Baseline (last 14 days before randomization) and Treatment Period (Day 85 to 6 months))
- Number of Participants With Well Controlled Asthma Weeks at Baseline(Last 2 weeks before randomization)
研究者
研究点 (1)
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