EUCTR2013-003043-36-BG进行中（未招募）不适用
A multicentre, randomised, double-blind, active-controlled, 3-way cross-over study to evaluate the efficacy and safety of a free combination of 3 doses of CHF 5259 (glycopyrrolate) plus Foster® 100/6µg (fixed combination of beclomethasone dipropionate plus formoterol) in a metered dose inhaler for the treatment of patients with uncontrolled asthma under medium doses of inhaled corticosteroids plus long-acting ß2-agonists - TRISKE
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
- 220
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 written informed consent obtained prior to any study-related procedures.
- •2.Male or female patients aged =18.
- •3.Patients with uncontrolled asthma on medium doses of ICS+LABA (>500-1000 µg daily dose BDP non-extrafine or equivalent plus formoterol 24 µg or salmeterol 100 µg) at a stable dose for at least 4 weeks prior to screening.
- •Drug*Medium daily dose
- •BDP non-extrafine >500-1000 µg
- •BDP extrafine >250-500 µg
- •Budesonide >400-800 µg
- •Ciclesonide >160-320 µg
- •Fluticasone >250-500 µg
- •Mometasone =400 µg-<800 µg
- •4.Patients with a pre-bronchodilator FEV1 =40% and <80% of their predicted normal value, after appropriate washout from bronchodilators, at screening and at the end of the run-in period.
- •5.Patients with a positive response to the reversibility test at screening within 30 minutes after administration of 400 µg of salbutamol pMDI, defined as ?FEV1 =12% and =200mL over baseline.
- •Note: In case the reversibility threshold is not met, the test can be performed once before randomisation.
- •6.Patients with uncontrolled asthma evidenced by a score at the Asthma Control Questionnaire© (ACQ) =1.5 (criterion must be met at screening and at the end of the run-in period).
- •7.Patients with a co-operative attitude and ability to be trained to correctly use the pMDI.
- •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 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 70
排除标准
- •1.Inability to carry out pulmonary lung function testing, to comply with study procedures or with study treatment intake.
- •2.History of near fatal asthma or of a past hospitalisation for asthma in intensive care unit or of frequent exacerbations which, in the judgement of the investigator, may place the patient at undue risk.
- •3.Hospitalisation, emergency room admission or use of systemic corticosteroids for asthma exacerbation in the 4 weeks prior to screening visit and during the run-in period.
- •4.Lower respiratory tract infection in the 4 weeks before the screening visit or during the run-in period.
- •5.Patients who are in therapy for gastroesophageal reflux disease (GERD) and/or patients with a medical history of GERD that leads to asthma symptoms.
- •6.Patients with a seasonal worsening of asthma and who cannot complete the study outside the relevant allergen season.
- •7.History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency, or any other significant lung disease which may interfere with data evaluation.
- •8.Patients who suffer from COPD as defined by the current GOLD guidelines.
- •9.Current smokers or ex-smokers with total cumulative exposure equal or more than 10 pack-years and /or having stopped smoking one year or less prior to screening visit.
- •10.Any change in dose, schedule, formulation of ICS + LABAs in the 4 weeks prior to screening visit.
- •11.Patients used to be or being treated with inhaled long-acting antimuscarinic drugs.
- •12.Patients being treated with anti-IgE antibodies
- •13.Pregnant or lactating women and all women physiologically capable of becoming pregnant (i.e. women of childbearing potential) UNLESS are using one or more reliable methods of contraception
- •14.Patients who have received an investigational drug within 2 months before screening visit.
- •15.Patients who have clinically significant cardiovascular condition according to investigator’s judgement
- •16.An abnormal and clinically significant 12-lead ECG that results in active medical problem which may impact the safety of the patient according to investigator’s judgement.
- •17.Patients whose electrocardiogram (12-lead ECG) shows QTcF >450 ms for males or QTcF >470 ms for females at screening or at randomisation visits.
- •18.Medical diagnosis of narrow-angle glaucoma, clinically relevant prostatic hypertrophy or bladder neck obstruction that, in the opinion of the investigator, would prevent use of anticholinergic agents.
- •19.Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration and, in the judgment of the investigator, would make the patient inappropriate for entry into this study, place the patients at undue risk or potentially compromise the results or interpretation of the study.
- •20.Patients having received a live-attenuated virus vaccination within two weeks prior to screening or during the run-in (inactivated influenza vaccination is acceptable provided it is not administered less than 48 hours prior to screening).
- •21.Patients mentally or legally incapacitated.
- •22.Patients with a history of alcohol or drug abuse.
- •23.Patients with known intolerance/hypersensitivity or contra-indication to treatment with ß2-agonists, inhaled corticosteroids, anti-cholinergics or propellant gases/excipients.
- •24.Patients with major surgery in the 3 months prior to screening visit and/or planned surgery during the
研究者
相似试验
进行中（未招募）
不适用
A research study to evaluate the effect of 3 different doses of a new medicine (glycopyrrolate) administered in combination with a licenced medicine (Foster®) in patients with uncontrolled asthmauncontrolled asthmaMedDRA version: 17.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2013-003043-36-DECHIESI FARMACEUTICI S.p.A220
进行中（未招募）
不适用
A clinical trial to assess the most efficacious dose of bronchodilator, Glycopyrrolate, to add to the existing treatment (Foster®, Beclomethasone + Formoterol) for the development of a new triple therapy in a single aerosol for the treatment of patients suffering from severe COPD.Chronic Obstructive Pulmonary DiseaseEUCTR2011-003588-31-PLChiesi Farmaceutici S.p.A.180
进行中（未招募）
不适用
A clinical trial to assess the most efficacious dose of bronchodilator, Glycopyrrolate, to add to the existing treatment (Foster, Beclomethasone + Formoterol) for the development of a new triple therapy in a single aerosol for the treatment of patients suffering from severe COPD.Chronic Obstructive Pumlonary DiseaseMedDRA version: 14.1Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2011-003588-31-ITCHIESI180
进行中（未招募）
不适用
A research study to evaluate the effect of 3 different doses of a new medicine (glycopyrrolate) administered in combination with a licenced medicine (Foster®) in patients with uncontrolled asthmauncontrolled asthmaMedDRA version: 16.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2013-003043-36-GBCHIESI FARMACEUTICI S.p.A220
进行中（未招募）
不适用
A clinical trial to assess the most efficacious dose of bronchodilator, Glycopyrrolate, to add to the existing treatment (Foster®, Beclomethasone + Formoterol) for the development of a new triple therapy in a single aerosol for the treatment of patients suffering from severe COPD.Chronic Obstructive Pulmonary DiseaseEUCTR2011-003588-31-HUChiesi Farmaceutici S.p.A.180