EUCTR2009-010267-17-DE进行中（未招募）不适用
IN-VIVO DEPOSITION MEASUREMENT OF BECLOMETASONE AND FORMOTEROL AFTER INHALATION OF A SINGLE DOSE OF THE COMBINATION BDP PLUS FORMOTEROL NEXT (TM) DPI IN HEALTHY VOLUNTEERS, ASTHMATIC AND COPD PATIENTS
适应症
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
- •Inclusion criteria
- •Healthy volunteers:
- •1.Males and females without childbearing potential aged 21-65 years;
- •2.Ability to use the NEXT(TM)DPI;
- •3.Body Mass Index (BMI) between 18.0 and 28.0 kg/m2;
- •4.Non- or ex-smokers who smoked < 5 pack years (pack-years = the number of cigarette packs per day times the number of years e.g. < 20 cigarettes per day for 5 years and 40 cigarettes per day for 2.5 years) and stopped smoking > 1 year;
- •5.Good physical and mental status, determined on the basis of the medical history and a general clinical examination;
- •6.Normal blood pressure and heart rate (100 = SBP = 150; 45 = DBP =90; 40 = HR = 100);
- •7.Electrocardiogram (ECG) (12 lead) with computerized protocol interpretation considered as normal (120 ms = PR = 220 ms, QRS = 120 ms, QTc = 450 ms). Minor deviations are acceptable provided the at they are not judged clinically significant by the investigator.
- •8.Results of laboratory tests within the normal ranges. Minor deviations are acceptable provided that they are not judged clinically significant by the investigator.
- •9.Understanding of the study and agreement to give written informed consent before the first selection procedure
- •Patients with Asthma:
- •1.Males and females (without childbearing potential) asthma patients aged 21-65 years;
- •2.Ability to use the NEXT(TM)DPI;
- •3.Body Mass Index (BMI) between 18.0 and 28.0 kg/m2;
- •4.Non- or ex-smokers who smoked < 5 pack years (e.g. < 20 cigarettes per day for 5 years and 40 cigarettes per day for 2.5 years) and stopped smoking > 1 year;
- •5.Normal blood pressure and heart rate (100 = SBP = 150; 45 = DBP =90; 40 = HR = 100);
- •6.ECG (12 lead) with computerized protocol interpretation considered as normal (120 ms = PR = 220 ms, QRS = 120 ms, QTc = 450 ms). Minor deviations are acceptable provided that they are not judged clinically significant by the investigator.
- •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 [2]) 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 15 minutes after inhalation of 200 µg 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.Understanding of the study and agreement to give written informed consent before the first selection procedure.
- •Patients with COPD:
- •1.Males and females without childbearing potential aged 40 – 70 years
- •2.Ability to use the NEXT(TM)DPI;
- •3.Body Mass Index (BMI) between 18.0 and 30.0 kg/m2;
- •4.Normal blood pressure and heart rate (100 = SBP = 150; 45 = DBP =90; 40 = HR = 100);
- •5.ECG (12 lead) with computerized protocol interpretation considered as normal (120 ms = PR = 220 ms, QRS= 120 ms, QTc= 450 ms). Minor deviations are acceptable provided that they are not judged clinically significant by the investigator;
- •6.Stable COPD within the past 4 weeks;
- •7.Post bronchodilator FEV1 between 30% and 50% predicted values (30% = FEV1 < 50%) documented at screening visit ;
- •8.Post bronchodilator FEV1/Forced Vital Capacity (FEV1/FVC) ? 0.70 (absolute value) documented at screening visit;
排除标准
- •Exclusion criteria
- •All subjects:
- •1.Blood donation (equal or more than 450 ml) or blood loss less than 8 weeks before inhalation of the study medication;
- •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 1). 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 another clinical trial less than 8 weeks prior to inhalation of the study medication; participation in study using radioactive material within 1 calendar year;
- •10.Known sensitivity to Formoterol or Beclometasone or any of the excipients contained in any of the formulations used in the trial;
- •11.Enzyme-inducing or inhibiting drugs taken within 2 months before the inhalation of the study medication.
- •12.Concomitant severe diseases or diseases which are contra indications for the use of inhaled ß2-agonist or steroids;
- •13.Use of any prescription drug for which concomitant beta-agonist or steroid administration are contraindicated;
- •14.History of significant sensitivity, allergy or intolerance to study drug formulation ingredients;
- •15.Recent relevant infectious disease (less than two months);
- •16.Flu vaccination within 4 weeks prior to the screening visit;
- •17.Other vaccination within 4 weeks prior to the screening visit;
- •18.Subjects unlikely to comply with the study protocol or unable to understand the nature and scope of the study but also the possible benefits or unwanted effects of the study treatments;
- •Additional exclusion criteria for healthy volunteers
- •1.Lung function measurements outside normal limits (Normal values: FEV1/FVC > 0.70 (absolute value) and FEV1 and FVC > 80% for the European Community for Coal and Steel 1993 predicted values) or other standard values for healthy volunteers;
- •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 2 l/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 exceedi
研究者
相似试验
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 patientsThe study is focused on asthma bronchiale and chronic obstructive pulmonary disease (COPD)MedDRA version: 8.1Level: PTClassification code 10003553Term: AsthmaEUCTR2006-005557-30-DEChiesi Farmaceutici S.p.A.
已完成
1 期
Lung Deposition of the BDP/Formoterol Combination Administered Via the NEXT DPI in Healthy, Asthmatic and COPD PatientsPulmonary Disease, Chronic ObstructiveAsthmaNCT01176747Chiesi Farmaceutici S.p.A.28
招募中
3 期
Comparison of aqueous and aerosol beclomethasone sprays in nasal polypsIRCT20171030037093N32Esfahan University of Medical Sciences70
进行中（未招募）
1 期
EFFICACY AND SAFETY OF BECLOMETHASONE DIPROPIONATE GASTRO-RESISTANT, PROLONGED RELEASE TABLETS (CHF 1514) COMPARED WITH ORAL PREDNISONE, IN A 8-WEEK TREATMENT PERIOD, IN PATIENTS WITH ACTIVE ULCERATIVE COLITIS. AN INTERNATIONAL, MUTICENTRE, RANDOMISED, DOUBLE BLIND, PARALLEL GROUP STUDY - Beta studylcerative Colitis extending proximally beyond the rectum with bleeding, verified by endoscopic examinationMedDRA version: 9.1Level: LLTClassification code 10045365Term: Ulcerative colitisEUCTR2006-004230-32-PLChiesi Farmaceutici SpA300
招募中
2 期
Effects of Betamethasone In Total Knee ArthroplastyIRCT20200627047934N1Islamic Azad University30