EUCTR2020-002086-34-CZ进行中（未招募）1 期
A Phase III randomized, placebo-controlled study to evaluate the efficacy and safety of ensifentrine over 24 weeks (with a 48-week safety subset) in patients with chronic obstructive pulmonary disease.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 800
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Capable of giving informed consent indicating that they understand the purpose of the study and study procedures and agree to comply with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- •2. Patient must be 40 to 80 years of age inclusive, at the time of Screening.
- •3. Males are eligible to participate if they agree to use contraception as described in the contraceptive guidance (Section 11.8) from Screening and throughout the study and for at least 30 days after the last dose of blinded study medication. Females are eligible to participate if they are not pregnant, not breastfeeding, and at least one of the following conditions apply:
- •a) Not a woman of childbearing potential (WOCBP) as defined in the protocol
- •b) A WOCBP who agrees to follow the contraceptive guidance in Section 11.8 of the protocol from Screening and throughout the study and for at least 30 days after the last dose of blinded study medication.
- •4. Smoking History: Current or former cigarette smokers with a history of cigarette smoking =10 pack years at Screening (Visit 0) [number of pack years = (number of cigarettes per day / 20) × number of years smoked (eg, 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years)]. Pipe and/or cigar use cannot be used to calculate pack-year history. Former smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 0. Smoking cessation programs are permitted during the study.
- •5. COPD Diagnosis: Patients with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines (Celli BR, 2004) with symptoms compatible with COPD.
- •6. COPD Symptoms: A score of =2 on the Modified Medical Research Council
- •(mMRC) Dyspnea Scale.
- •7. COPD Severity:
- •a. Pre- and Post-albuterol/salbutamol FEV1/FVC ratio of <0.70.
- •b. Post-albuterol/salbutamol FEV1 =30 % and =70% of predicted normal calculated using the National Health and Nutrition Examination Survey III (Hankinson, 1999).
- •8.Maintenance Therapy: Patients on no maintenance/background
- •therapy or patients either on stable maintenance LAMA or LABA therapy
- •are eligible. Patients taking maintenance LAMA or LABA therapy must
- •demonstrate regular use of maintenance LAMA or LABA therapy, in any
- •form, for at least 2 months prior to Screening and agree to continue use
- •of their current permitted LAMA or LABA medication for the duration of
- •the study. Section 6.7.3 lists the medications that are prohibited during
- •the study and the prohibited time intervals prior to Screening.
- •Background maintenance LAMA or LABA bronchodilator therapy will be
- •capped at 50% of patients.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 500
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 300
排除标准
- •1. History of life-threatening COPD including Intensive Care Unit admission and/or requiring intubation.
- •2. Hospitalizations for COPD, pneumonia, or Corona Virus Disease 2019 (COVID-19) in the 12 weeks prior to Screening and/or a positive COVID-19 test result indicating an active infection at Screening. Patients with COVID-19 antibodies from a previous exposure with no active infection are not excluded.
- •3. COPD exacerbation requiring oral or parenteral steroids within 3 months of Screening.
- •4. Previous lung resection or lung reduction surgery within 1-year of Screening.
- •5. Long term oxygen use defined as oxygen therapy prescribed for greater than 12 hours per day. As needed oxygen use (=12 hours per day) is not exclusionary.
- •6. Pulmonary rehabilitation, unless such treatment has been in a stable maintenance phase for 4 weeks prior to Visit 1 and remains stable during the study
- •7. Lower respiratory tract infection within 6 weeks of Screening.
- •8. Other respiratory disorders including, but not limited to, a current diagnosis of asthma, active tuberculosis, lung cancer, sarcoidosis, lung fibrosis, interstitial lung diseases, unstable sleep apnea, known alpha-1 antitrypsin deficiency, core pulmonale, clinically significant pulmonary hypertension, clinically significant bronchiectasis, or other active pulmonary diseases.
- •9. Major surgery (requiring general anesthesia) in the 6 weeks prior to Screening, lack of full recovery from surgery at Screening, or planned surgery through the end of the study.
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