EUCTR2015-005550-35-GB进行中（未招募）1 期
A RANDOMISED, DOUBLE-BLIND, PLACEBO CONTROLLED, REPEATED DOSE, THREE-WAY CROSSOVER STUDY TO EVALUATE THE PHARMACODYNAMICS, PHARMACOKINETICS AND SAFETY OF TWO DOSES OF CHF 6001 DPI IN SUBJECTS WITH MODERATE, SEVERE COPD.
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 61
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. Male and female aged = 40 years
- •2. A female is eligible to enter the study if she is of non-childbearing potential i.e. physiologically incapable of becoming pregnant
- •3. Subjects with an established diagnosis of COPD (according to GOLD guidelines, update 2015) at least 12 months prior to the screening visit
- •4. With a smoking history of at least 10 pack-years [pack-years=number of cigarettes per day x number of years/20]. Current and ex- smokers are eligible. (Smoking cessation must be at least 3 months prior to the screening.
- •5. With a BMI in the range of 18-35 Kg/m2
- •6. With a post- bronchodilator FEV1 = 30% and = 70% of the subject normal predicted value and a post-bronchodilator FEV1/FVC ratio <0.70 measured 10-15 minutes after 400µg (4 puffs x 100µg) of salbutamol pMDI. If this criterion is not met at screening, the test can be repeated once before randomisation visit.
- •7. Subjects must be receiving daily maintenance with triple therapy (ICS plus LABA plus LAMA) at stable dose and dosing regimen, for at least 2 months prior to screening
- •8. With a history of chronic bronchitis defined as chronic cough and sputum production for more than three months per year for two or more years and known as ‘spontaneous sputum producer’ subject
- •9. At screening, subjects must be able to produce an adequate induced sputum sample defined as a load of at least 300 mg with a viability factor of not less than 70% (with less than 30% epithelial cells) and a neutrophil % differential count of at least 60%.
- •10. Subjects must be symptomatic at screening defined as having a CAT score =10
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1. Pregnant or lactating female subject
- •2. Subjects with a current diagnosis of asthma
- •3. Subjects with a moderate or severe COPD exacerbation [i.e. resulting in the use of systemic (oral/IV/IM corticosteroids) and/or antibiotics or in hospitalisation] or a lower respiratory tract infection within 6 weeks prior to study entry or during the screening period
- •4. Subjects on maintenance bronchodilators therapy only (LABA alone, LAMA alone, dual LABA/LAMA alone) or maintenance dual therapy only (ICS/LABA or ICS plus LAMA) within 2 months prior to study entry
- •5. Subjects on PDE4 inhibitors (e.g. roflumilast) within 2 months prior to study entry
- •6. Subjects requiring long-term (at least 12 hours daily) oxygen therapy for chronic hypoxemia
- •7. Subjects participating to a pulmonary rehabilitation programme or completing such a programme within the last 6 weeks prior to study entry
- •8. Subjects with known respiratory disorders other than COPD that in investigator’s opinion would affect efficacy and safety evaluation or place the subject at risk. This can include but is not limited to known alpha-1 antitrypsin deficiency, active tuberculosis, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension and interstitial lung disease
- •9. Subjects with active (lung) cancer or a history of lung cancer ;or a history of cancer other than lung cancer with less than 5 years disease free survival time (whether or not there is evidence of local recurrence or metastases). Localized carcinoma (e.g. basal cell carcinoma (without metastases), in situ carcinoma of the cervix adequately treated,) is acceptable
- •10. Subjects with a known history of hypersensitivity to ß2-agonist, PDE4 inhibitors or any of the excipients contained in any of the formulations used in the trial
- •11. Subjects who have known history of clinically significant cardiovascular conditions such as, but not limited to, unstable or acute ischemic heart disease within one year prior to study entry, NYHA Class III/IV heart failure, known history of sustained and non-sustained cardiac arrhythmias or history of atrial fibrillation diagnosed in the last 6 months prior to study entry and not controlled with therapy rate control strategy as well as subjects with a history or symptoms of significant neurological disease including transient ischemic attack (TIA), stroke, seizure disorder or behavioural disturbances
- •12. Male subjects with a QTcF >450 ms and female subjects with a QTcF >470 ms at screening and/or at randomisation visits
- •13. Subjects who have unstable concurrent disease: e.g. uncontrolled hyperthyroidism, uncontrolled diabetes mellitus or other endocrine disease; significant hepatic impairment, significant renal impairment; history of cerebrovascular disease; uncontrolled gastrointestinal disease (e.g. active peptic ulcer, Crohn’s disease, ulcerative colitis, enteritis, unexplained diarrhea, bloody or loose stools); uncontrolled haematological disease; uncontrolled autoimmune disorders (e.g. rheumatoid arthritis, inflammatory bowel disease) or other disease or condition that might, in the judgement of the investigator , place the subject at undue risk or potentially compromise the results or interpretation of the study
- •14. Subjects with abnormal alanine aminotransferase (ALT) =2x upper limit of normal (ULN) and/ or aspartate aminotransferase (AST) =2x ULN and/or bilirubin =1.5x ULN. Isolated bilirubin =1.5x ULN is acceptable if fractionated and direct bilirubin is <35%
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