EUCTR2006-005557-30-DE进行中（未招募）不适用
In-vivo deposition measurement of formoterol and beclomethasone after inhalation of a single dose of the combination Formoterol plus BDP HFA pMDI (Foster®, Chiesi) in healthy volunteers, asthmatic and 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）
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 subjects:
- •1.Age 21 - 70
- •2.Ability to properly use the pMDI
- •3.Body Mass Index (BMI) between 18.0 and 30 kg/m2
- •4.Normal blood pressure and heart rate (supine SBP 100-150 mmHg, supine
- •DBP 50-90 mmHg, heart rate 50-90 bpm)
- •5.Electrocardiogram (12 lead) with computerized protocol interpretation
- •considered as normal (120 ms=PR=220ms, QRS=120ms, QTc=450ms).
- •6.Non-smokers or ex-smokers with a smoking history of less than 5 pack-
- •years and stopped smoking at least one year ago.
- •7.written informed consent
- •Patients with Asthma:
- •1.Age 21 - 70
- •2.Ability to properly use the pMDI
- •3.Body Mass Index (BMI) between 18.0 and 30 kg/m2
- •4.Normal blood pressure and heart rate (supine SBP 100-150 mmHg, supine
- •DBP 50-90 mmHg, heart rate 50-90 bpm).
- •5.Electrocardiogram (12 lead) with computerized protocol interpretation
- •considered as normal (120 ms=PR=220ms, QRS=120ms, QTc=450ms).
- •6.Patients with moderate persistent or severe persistent Asthma according
- •to the GINA Classification of Asthma Severity by Daily Medication Regimen
- •and Response to Treatment.
- •7.FEV1 = 30% and < 80% of predicted for the patient’s normal value
- •(according to the predicted value for spirometric function, European Coal
- •and Steel Community values) measured at least 8 hours after the last
- •use of short-acting ß2-agonist bronchodilators or short-acting
- •anticholinergics, 72 hours after the last use of long-acting ß2- agonist
- •bronchodilators and 72 hours after the last use of long-acting
- •anticholinergics.
- •8.Reversibility of FEV1 = 12% and at least 200 ml of the initial value 30
- •minutes after inhalation of 200 mcg Salbutamol within the screening period
- •9.In good health on the basis of a medical history, physical examination,
- •clinical laboratory studies and ECG with the exception of Asthma
- •10.Non-smokers or ex-smokers with a smoking history of less than 5 pack-
- •years (e.g. < 20 cigarettes per day for 5 years or 40 cigarettes per day for
- •2.5 years) and stopped smoking at least 1 year ago.
- •11.written informed consent
- •Patients with COPD:
- •1.Age 40 - 70
- •2.Ability to properly use the pMDI
- •3.Body weight resulting in a Body Mass Index (BMI) between 18.0 and 30
- •4.Normal blood pressure and heart rate (supine SBP 100-150 mmHg, supine
- •DBP 50- 90 mmHg, heart rate 50-90 bpm).
- •5.Electrocardiogram (12 lead) with computerized protocol interpretation
- •considered as normal (120 ms=PR=220ms, QRS=120ms, QTc=450ms).
- •6.Stable COPD
- •7.Decreased FEV1 between 30% and 50% predicted values (30% =FEV1 <
- •50%) measured at least 8 hours after the last use of short-acting ß2-
- •agonist bronchodilators or short-acting anticholinergics, 72 hours after the
- •last use of long-acting ß2-agonist bronchodilators and 72 hours after the
- 另有 5 项未显示
排除标准
- •All subjects:
- •1.Blood donation (equal or more than 450 ml) or blood loss less than 8
- •weeks before the first intake of study drug
- •2.Positive HIV1 or HIV2 serology
- •3.Positive results from the Hepatitis serology which indicates acute or
- •chronic Hepatitis B or Hepatitis C
- •4.Unsuitable veins for repeated venipuncture
- •5.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
- •6.History of substance abuse or drug abuse within 12 months or with a
- •positive urine drug screen
- •7.Clinically relevant abnormal laboratory values suggesting an unknown
- •disease and requiring further clinical investigation
- •8.Clinically significant and uncontrolled cardiac, hepatic, renal,
- •gastrointestinal, endocrine, metabolic, neurologic, or psychiatric disorder
- •that may interfere with successful completion of this protocol
- •9.Participation in an investigational drug study within 30 days prior to Visit 1
- •or current participation in another investigational drug study
- •10.Known sensitivity to Formoterol or Beclomethasone or any of the
- •excipients contained in any of the formulations used in the trial.
- •11.Concomitant severe diseases or diseases which are contra indications for
- •the use of inhaled ?2-agonist or steroids.
- •12.Use of any prescription drug for which concomitant beta-agonist or steroid
- •administration are contraindicated.
- •13.History of significant sensitivity, allergy or intolerance to study drug
- •formulation ingredients.
- •14.Recent relevant infectious disease (less than two months)
- •15.Flu vaccination within 4 weeks prior to the screening visit
- •16.Other vaccination within 4 weeks prior to the screening visit
- •Additional exclusion criteria for patients with Asthma:
- •1.Use of systemic steroids 4 weeks prior to inclusion (injectable depot
- •steroids 6 weeks) or more than 3 periods during the last 6 months
- •2.Life-threatening/unstable respiratory status including upper or lower
- •respiratory tract infection, within the previous 30 days
- •3.Requirement of continuous supplemental oxygen therapy; the use of
- •supplemental oxygen not exceeding 2l/min, at night time only and/or only
- •during exercise is allowed
- •4.Change in dose or type of any medications for asthma within 4 weeks
- •prior to the screening visit
- •5.Asthma exacerbation within the 4 weeks prior to inclusion
- •Additional exclusion criteria for patients with COPD:
- •1.Use of systemic steroids 4 weeks prior to inclusion (injectable depot
- •steroids 6 weeks) or more than 3 periods during the last 6 months
- •2.Life-threatening/unstable respiratory status including upper or lower
- •respiratory tract infection, within the previous 30 days
- •3.Requirement of continuous supplemental oxygen therapy; the use of
- •supplemental oxygen not exceeding 2l/min, at night time only and/or only
- •during exercise is allowed
- •4.Change in dose or type of any medications for COPD within 4 weeks prior
- 另有 3 项未显示
研究者
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