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临床试验/EUCTR2015-005551-27-GB
EUCTR2015-005551-27-GB进行中（未招募）1 期

A First in Human Randomised, Double-Blind, Placebo-Controlled Study of Single Ascending Doses in Healthy Male Volunteers and Repeated Ascending Dose in Asthmatic Patients Followed by a 3-Way Cross-Over, Placebo-Controlled, Single-Dose in COPD Patients to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CHF6366 - Study of CHF6366 in healthy males and patients with Asthma and COPD

Chiesi Farmaceutici0 个研究点目标入组 106 人开始时间: 2017年10月30日最近更新:
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试验速览

阶段
1 期
状态
进行中（未招募）
发起方
入组人数
106
研究概览入排标准研究者记录与标识符相似试验

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

  • •-Healthy male subjects, 18-55yrs
  • •-BMI between 18.5 and 32.0kg/m2
  • •-Non-or ex-smokers who smoked <5 pack years and stopped smoking >1 year
  • •-Vital signs within normal limits at screen and prior to randomisation: Diastolic BP 50-90, Systolic BP 90-140 (2 measures after at least 5 minutes resting. For eligibility purposes, the 2 single measurements will be considered). Body temperature 36-37.2ºC
  • •-12-lead ECG considered as normal (45= Heart rate =85bpm, 110ms= PR =200 ms, QRS =120 ms, QTcF =450 ms) at screen visit and prior to randomisation
  • •-Lung function measurements within normal limits at screen and prior to randomisation: FEV1 equal to or more than 80% of predicted for the subject’s normal value according to GLI, ERS Task Force Lung Function Reference Values and FEV1/FVC ratio >0.70
  • •-Male and female subjects, 18-75yrs
  • •-Clinical diagnosis of mild persistent asthma (according to GINA guidelines) for at least 6 months prior to screen
  • •-Non-or ex-smokers who smoked <5 pack years and stopped smoking >1 year
  • •-Vital signs within normal limits at screen and prior to randomisation: Diastolic BP 50-90, Systolic BP 90-150. Body temperature 36-37.2ºC
  • •- Normal resting ECG (after 5 minutes resting) (heart rate 45 to 100 bpm, PR 120 to 200 msec, QRS =120 msec, QTcF =450 msec (male) and QTcF =470 (female),
  • •-Screen FEV1 value of =70% of the predicted normal value after a washout of at least 8h for short-acting beta2-agonists and 14 days for long-acting beta2-agonists or long acting antimuscarinic
  • •-FEV1 reversibility of = 12% or 200ml over the baseline value within 20-30min after inhalation of 400 µg of salbutamol
  • •-Using intermittent salbutamol and/or subjects on a stable dose or regimen of low dose ICS at least 4 weeks prior to screen and between screening and first dose
  • •-Otherwise healthy as determined by medical history, physical examination, 12-lead ECG findings
  • •-Male and female adults, aged 40-75yrs
  • •-Vital signs at screen and prior to randomisation: Diastolic BP 50-90, Systolic BP 90-160. Body temperature 36-37.2ºC
  • •-Normal resting ECG (after 5 minutes resting) (HR 50 to 100 bpm, PR interval 120 to 200 msec, QRS duration <120 msec, QTcF <450 msec (male) and <470 msec (female))
  • •-Outpatients with diagnosis of COPD (according to current GOLD guidelines)
  • •-A smoking history of at least 10 pack years, current smokers and ex-smokers are eligible
  • •-A post-bronchodilator 40%= FEV1 <80% of the predicted normal value, post-bronchodilator FEV1/FVC <0.7 with salbutamol
  • •-Treated with a stable therapy for at least 1 month prior to screen with any of the below:
  • •- Short acting ß2-agonist and/or short acting anticholinergic prn,
  • •- inhaled long acting ß2-agonist and/or long-acting muscarinic antagonist,
  • •- fixed combination of inhaled long acting ß2-agonist and long-acting muscarinic antagonist
  • •- fixed combination of LABA/LAMA/ICS
  • •-Response to ipratropium bromide, an increase in FEV1 of =7 % starting 30-45min after inhalation of 80µg ipratropium bromide at screen visit
  • •-Response to salbutamol, an increase in FEV1 of =7 % starting 20-30min following inhalation of 400µg salbutamol MDI at screen visit
  • •Applicable to Parts 2 & 3
  • •-Female subject of non-childbearing potential (WONCBP) defined as physiologically incapable of becoming pregnant (i.e. post-menopausal or permanently sterile). Tubal ligation or partial surgical interventions are not acceptable. If indicated, as per investigator’s request, post-menopausal status m

排除标准

  • •- Female Subjects
  • •- History of sustained and non-sustained cardiac arrhythmias and subjects with a family history of sudden cardiac death
  • •- Blood donation or blood loss (=450 ml) less than 12 weeks prior to screen or randomisation
  • •- Clinically relevant and uncontrolled hepatic, gastrointestinal, endocrine, metabolic, neurologic, or psychiatric disorder
  • •- Serum K value <3.8 mmol/L
  • •- Taken non-permitted concomitant medications, including vitamins and herbal remedies such as St John’s Wort, in the predefined period
  • •- Heavy caffeine drinker (>5 cups a day)
  • •- Positive urine test for cotinine
  • •- Treated within 2 months before screen and before the first dose with enzyme-inducing or inhibiting drugs
  • •- Treated within 4 weeks before screen with antibiotics
  • •- Pregnant and/or breastfeeding women
  • •- Uncontrolled asthmatic patients according to GINA criteria
  • •- Medical history or current diagnosis of COPD or any other pulmonary disease other than asthma
  • •- History of near fatal asthma or of a past hospitalisation for asthma in intensive care unit or of frequent exacerbations in the last year
  • •- Therapy for gastroesophageal reflux disease or patients with a medical history of GERD that leads to asthma symptoms
  • •- Change in dose, schedule, of ICS in the 4 weeks prior to screen or between screen and first dose
  • •- Hospitalization, emergency room admission or use of systemic corticosteroids for an asthma exacerbation in the 6 weeks prior to screen or between screen and first dose
  • •- Seasonal worsening of asthma and cannot complete the study outside the relevant allergen season
  • •- Systolic Blood pressure <90 or >140 (as mean of 2 measures after at least 5 minute of resting)
  • •- Unstable and uncontrolled blood pressure <60 or >90 mmHg (as mean of 2 measures)
  • •- Abnormal resting ECG (heart rate <40 bpm or >10 bpm, PR interval <120 or >200 msec, QRS duration >120 msec, QTcF >450 msec, any variation from normal waves and tracts morphology
  • •- Treated within 2 months before screen with enzyme-inducing or inhibiting drugs
  • •- Pregnant and/or breastfeeding women
  • •- Current diagnosis of asthma
  • •- Hospital admission for COPD exacerbation within 12 months prior to screen or before first dose
  • •- Hospitalization pneumonia within 3 months prior to screen or before first dose
  • •- Recent COPD exacerbations requiring oral/systemic steroids and/or antibiotics and/or oral or nebulized beta2-agonists or need for increased treatments for COPD
  • •- Use of antibiotics for a lower respiratory tract infection in the 4 weeks prior to screen or before first dose
  • •- Use of beta-blockers with the exception of cardioselective ß1-blockers, if taken for at least 2 months prior to screen and maintained constant during the study
  • •- Unstable concurrent disease: e.g. uncontrolled hyperthyroidism, uncontrolled diabetes mellitus or other endocrine disease significant hepatic impairment significant renal impairment significant non-COPD pulmonary disease (e.g. TB, lung cancer) uncontrolled gastrointestinal disease, neurological disease uncontrolled hematological disease uncontrolled autoimmune disorders
  • •- Abnormal resting ECG
  • •- Serum potassium levels below the lower limit of laboratories normal range
  • •- Diagnosis or a history of narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that would prevent use of anticholinergic
  • •- Treated with quinidine, quinidine-like anti arrhythmic and any medication with a potential for QT prolongation 24h prior to screen
  • •- Changes in dose, sc

研究者

发起方
Chiesi Farmaceutici

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