NCT04636801终止3 期
A 52-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Study to Evaluate the Efficacy and Safety of Two Doses of CHF6001 DPI add-on to Maintenance Triple Therapy in Subjects With Chronic Obstructive Pulmonary Disease (COPD) and Chronic Bronchitis
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 4,710
- 试验地点
- 447
- 主要终点
- The number of moderate and severe COPD exacerbations occurring during the planned 52-week treatment period.
研究概览
简要总结
The purpose of the study is to evaluate the efficacy and safety of two doses of CHF6001 (Tanimilast), as add-on to maintenance triple therapy in the target patient population.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged ≥ 40 years with COPD and chronic bronchitis
- •Current or ex-smokers (history ≥ 10 pack years).
- •Post-bronchodilator FEV1 <60% of the subject predicted normal value and FEV1/FVC ratio < 0.
- •At least, one moderate or severe COPD exacerbation in previous year.
- •CAT score ≥ 10
- •Subjects on regular maintenance triple therapy for at least 12 months prior to screening and receiving regular maintenance triple therapy for at least 3 months prior to screening visit
排除标准
- •Subjects with current asthma.
- •Subjects with moderate or severe COPD exacerbation 4 weeks prior to study entry and randomization.
- •Subjects with known α-1 antitrypsin deficiency as the underlying cause of COPD.
- •Subjects with COPD emphysema or mixed phenotypes.
- •Subjects with known respiratory disorders other than COPD.
- •Subjects with active cancer or a history of lung cancer with full recovery less than 1 year after completing cancer therapy.
- •Subjects under Roflumilast treatment within 6 months before study entry.
- •Subjects with a diagnosis of depression, generalised anxiety disorder, suicidal ideation.
- •Subjects with clinically significant cardiovascular.
- •Subjects with a significant neurological disease.
- •Subjects with clinically significant laboratory abnormalities.
- •Subjects with moderate or severe hepatic impairment
研究组 & 干预措施
CHF6001 Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
The number of moderate and severe COPD exacerbations occurring during the planned 52-week treatment period.
时间窗: Up to 52 weeks
Moderate or severe exacerbation is defined by symptomatic worsening of COPD: * Moderate: requiring use of systemic corticosteroid (oral/IV/IM corticosteroids), and/or use of antibiotics * Severe: requiring hospitalisation or resulting in death
次要结局
- The annual rate of severe exacerbation.(Up to 52 weeks)
- The time to first severe exacerbation.(Up to 52 weeks)
- The time to first moderate or severe exacerbation.(Up to 52 weeks)
- Time to study medication discontinuation for any reason.(Up to 52 weeks)
- SGRQ response (change from baseline SGRQ total score ≤ -4) at week 52.(At week 52)
- Change from baseline to last inter-visit period (week 40-52) in E-RS Total and subscale scores(Up to 52 weeks)
- E-RS response (change from baseline E-RS Total score ≤ -2) at week 52.(At week 52)
- Change from baseline to last inter-visit period (week 40-52) in the percentage of days without intake of rescue medication and in the average rescue medication use (number of puffs)(Up to 52 weeks)
- Time to moderate or severe exacerbation or study medication discontinuation due to any adverse event, lack of efficacy or death (composite endpoint) and time to study medication discontinuation component.(Up to 52 weeks)
- The number of on-treatment severe exacerbations.(Up to 52 weeks)
- Change from baseline (pre-dose visit 2) in pre-dose FEV1 at week 52.(At Week 52)
- Change from baseline in SGRQ total and domain scores at week 52.(At week 52)
研究者
研究点 (447)
Loading locations...
相似试验
已完成
3 期
Evaluation of Effectiveness and Safety of Paliperidone Extended Release in Patients With Schizoaffective Disorder.Psychotic DisorderSchizoaffective DisorderNCT00397033Johnson & Johnson Pharmaceutical Research & Development, L.L.C.316
已完成
2 期
A Study of Crofelemer to Treat Diarrhea Irritable Bowel SyndromeColonic DiseasesDiarrheaGastrointestinal DiseaseIrritable Bowel SyndromeNCT00101725Bausch Health Americas, Inc.245
已完成
2 期
MK0557 for the Treatment of Cognitive Impairment in Patients With Schizophrenia (0557-027)SchizophreniaParanoid SchizophreniaNCT00482430Merck Sharp & Dohme LLC50
已完成
1 期
A Study to Investigate Safety, Tolerability and Pharmacokinetics of AZD1446 Administered for 4 Weeks in Elderly Healthy VolunteersHealthyNCT00997308AstraZeneca97
已完成
1 期
A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986326 in Participants With Atopic DermatitisDermatitis, AtopicNCT06248814Bristol-Myers Squibb64