EUCTR2005-003693-14-DE进行中（未招募）不适用
In-vivo deposition of formoterol after inhalation of a single dose of Formoterol HFA- MDI (Chiesi), and Foradil P inhalation powder (Novartis) in COPD patients.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 8
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
- •Age 40 - 70
- •Ability to properly use the MDI and DPI
- •Body weight resulting in a Body Mass Index (BMI) between 18.0 and 35 kg/m2
- •Normal blood pressure and heart rate (supine SBP 100-140 mmHg, supine DBP 45-90 mmHg, heart rate 45-90 bpm). Minor deviations are acceptable provided that they are not judged relevant by the clinical investigator
- •Electrocardiogram (12 lead) with computerized protocol interpretation considered as normal (120ms ?PR? 220ms, QRS ?120ms, QTc ?450ms (male), ? 470 ms (female)). Minor deviations are acceptable provided that they are not judged relevant by the clinical investigator
- •Primary diagnosis of COPD (Diagnosis can be made during the screening process)
- •Moderate COPD (FEV1/FVC = 70 %, Stage III GOLD classification) documented at screening visit
- •Reversibility of FEV1 < 12 % of the initial value after inhalation of 200µg Salbutamol within the screening period
- •Treatment with inhaled ß2-agonists at a constant dosage during the last 4 weeks prior to inclusion
- •In good health on the basis of a medical history, physical examination, clinical laboratory studies and ECG, with the exception of COPD
- •Minimum smoking history of 10 pack-years (pack-years = the number of cigarette per day/ 20 x number of years)
- •Understanding of the study and agreement to give written informed consent before the first selection procedure.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Blood donation (equal or more than 450 ml) or blood loss less than 8 weeks before the first intake of study drug
- •Positive HIV1 or HIV2 serology
- •Positive results from the Hepatitis serology which indicates acute or chronic Hepatitis B or Hepatitis C
- •Unsuitable veins for repeated venipuncture
- •Female patients: pregnant, positive pregnancy test, lactating mother or lack of efficient contraception (according to CPMP/ICH 286/95 note 3 ). Postmenopausal women < 1 year must have efficient contraception
- •History of substance abuse or drug abuse within 12 months or with a positive urine drug screen
- •Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical investigation
- •Clinically significant and uncontrolled cardiac, hepatic, renal, gastrointestinal, endocrine, metabolic, neurologic, or psychiatric disorder that may interfere with successful completion of this protocol
- •Participation in an investigational drug study within 30 days prior to Visit 1 or current participation in another investigational drug study
- •Known sensitivity to Formoterol, Salmeterol or Albuterol or any of the excipients contained in any of these formulations
- •Concomitant severe diseases or diseases which are contra indications for the use of inhaled ?2-agonist
- •Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical investigation
- •Use of systemic steroids 4 weeks prior to inclusion (injectable depot steroids 6 weeks) or more than 3 periods during the last 6 months
- •History of significant sensitivity or allergy to ?2-agonists or related drugs
- •Recent relevant infectious disease (less than two months)
- •Life-threatening/unstable respiratory status including upper or lower respiratory tract infection, within the previous 30 days
- •Requirement of continuous supplemental oxygen therapy; the use of supplemental oxygen may not exceed 2l/min, at night time only and/or only during exercise is allowed
- •Change in dose or type of any medications for COPD within 4 weeks prior to the screening visit
- •Use of any prescription drug for which concomitant beta-agonist administration is contraindicated
- •Exacerbation within the 4 weeks prior to inclusion
研究者
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