EUCTR2019-002238-35-PL进行中（未招募）1 期
A SINGLE-DOSE, UNCONTROLLED, OPEN LABEL, NON-RANDOMIZED,CLINICAL PHARMACOLOGY STUDY OF CHF 5993 100/6/12.5 µg PMDI (FIXED COMBINATIONOF BECLOMETASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE PLUS GLYCOPYRRONIUM BROMIDE) IN ASTHMATIC ADOLESCENT PATIENTS AND ADULT PATIENTS
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
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. Patient’s and / or patient legal representative’s/parents’ (where applicable) written informed consent obtained prior to any study related procedure.
- •2. Ability to understand the study procedures, the risks involved, and ability to be trained to use the pMDI device correctly with AIM™ (Aerosol Inhalation Monitor) Vitalograph®.
- •3. Male and female adolescents, aged = 12 and < 18 years or male and female adults, aged = 18 and < 65 years.
- •4. Body mass index (BMI) within the range of 18.0 to 30.0 kg/m2 inclusive.
- •5. A diagnosis of asthma as defined in the GINA guidelines (updated 2019) 6 months before the screening visit.
- •6. Male/female adolescent and adult patients with controlled asthma according to GINA guidelines (updated 2019) to allow a wash out period from inhaled BDP of 2 days before study treatment visit.
- •7. Male/female adolescents and adults with controlled asthma on regular treatment with medium doses of ICS according to GINA guideline alone or in fixed dose combinations with LABA and using short-acting inhaled ß2-agonists as a reliever. Inhaled Corticosteroid Adults and adolescents
- •8. Adolescents and adults with a forced expiratory volume in one second (FEV1)> 70% of predicted values (% pred) after withholding short acting ß2-agonist treatment for a minimum of 6h prior to screening or 24 hours in case of long acting ß2-agonist.
- •9. Non-smokers or ex-smokers who smoked < 5 pack years (packyears= the number of cigarette packs per day, times the number of years) and stopped smoking > 1 year prior to screening.
- •10. Good physical and mental status, determined on the basis of the medical history and a general clinical examination, at screening and at Visit 1 before dosing.
- •11. Female patients of non-childbearing potential (WONCBP) defined as physiologically incapable of becoming pregnant (i.e. post-menopausal or permanently sterile) and female patients of childbearing potential (WOCBP) fulfilling one of the following
- •a. WOCBP with fertile male partners: they and/or their partner must be willing to use a highly effective birth control method from the signature of the informed consent and until the follow-up visit or
- •b. WOCBP with non-fertile male partners (contraception is not required in this case).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 40
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Blood donation (equal or more than 450 ml) or blood loss, less than 2 months prior to screening or prior to Visit 1.
- •2. Abnormal haemoglobin level defined as < 12,0 g/dl in females and < 14,0 g/dl in males.
- •3. For females only: pregnant and lactating female patients, confirmed by a positive serum pregnancy test at screening or urine pregnancy test at Visit 1 before dosing.
- •4. Diagnosis of COPD, in adult patients, as defined by the current GOLD guidelines (2019 Report).
- •5. Positive to HIV1 or HIV2 or positive results for Hepatitis which
- •indicates acute or chronic Hepatitis B (i.e. positive HB surface antigen HBsAg, positive HB core antibody anti-HBc) or Hepatitis C (positive HCV antibody).
- •6. Unsuitable veins for repeated venepuncture.
- •7. Documented history of alcohol abuse within 12 months prior to screening.
- •8. Documented history of drug abuse within 12 months prior to screening, or positive urine drug test performed at screening or before dosing.
- •9. Patients who have a positive urine test for cotinine at screening or before dosing.
- •10. Clinically relevant abnormal laboratory values, suggesting an unknown disease and requiring further clinical investigation.
- •11. Clinically relevant and uncontrolled cardiac, hepatic, renal, gastrointestinal, endocrine, metabolic, neurologic, or psychiatric disorder that may interfere with successful completion of this protocol.
- •12. Known intolerance/hypersensitivity to any of the excipients/components contained in any of the formulations used in the trial.
- •13. Patients with medical diagnosis of narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that in the opinion of the investigator would prevent use of an anticholinergic.
- •14. Abnormal 12-lead digitized Electrocardiogram (12-lead ECG) parameter (i.e.: QRS > 120 msec and/or PR > 210 msec and/or HR < 40 bpm and/or HR > 110 bpm and/or QTcF > 450 ms for males or QTcF > 470 ms for females, considering the average from triplicate) or 12-lead ECG evaluated as abnormal clinically significant by the investigator, at screening.
- •15. Abnormal Blood Pressure (i.e.: Diastolic Blood Pressure > 90 mmHg and/or Systolic Blood Pressure > 140 mmHg, considering the average from triplicate) at screening.
- •16. Participation in another clinical trial with an investigational drug in the 30 days or 5 half-lives of that investigational drug (whichever is longer) preceding the administration of the study drug; a longer and more appropriate time could be considered by the principal investigator based on the elimination half-life and/or
- •long-term toxicity of the previous investigational drug.
- •17. Patients taking enzyme-inducing drugs, enzyme-inhibiting drugs, biologic drugs or any drug known to have a well-defined potential for hepatotoxicity (e.g. isoniazide, nimesulide, ketoconazole) in the 3 months before screening or Visit 1.
- •18. Patients who have a high caffeine intake (> 5 caffeinated beverages e.g., coffee, tea, cola per day).
- •19. Patients who have had a lower respiratory tract infection (LRTI) within 4 weeks prior to screening or Visit 1.
- •20. Patients who are night shift workers with night shifts within 8 weeks prior to screening or Visit 1 and during the study.
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