EUCTR2016-003672-47-GB进行中（未招募）1 期
A single dose, randomised, double blind, double dummy, placebo controlled, 3-way crossover clinical study, comparing the onset of relief from methacholine-induced bronchoconstriction with CHF1535 100/6 µg NEXThaler® versus CHF1535 100/6 µg pMDI in asthmatic 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
- 60
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
- •- Patient's written informed consent obtained prior to any study-related procedure;
- •- Male or female aged between 18 and 60 years inclusive;
- •- Ability to understand the study procedures and to be trained to use the inhalers correctly;
- •- Non- or ex-smokers who smoked < 5 pack years;
- •- Diagnosis of asthma for a minimum of 6 months;
- •- Pre-bronchodilator FEV1 = 65% of the predicted normal value and at
- •least 1.5 L;
- •- A positive response to methacholine challenge test and return to = 85% of baseline value after salbutamol intake;
- •- Previous treatment with low-medium doses of ICS or ICS plus
- •LABA (as per current GINA guidelines) for at least two months at stable doses;
- •- Applicable to WOCBP only: willing to use highly effective birth control method (if applicable), non-lactating and non-pregnant.
- •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 60
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Clinically relevant and uncontrolled concomitant diseases or disorders that may interfere with successful completion of this protocol in the investigator's opinion;
- •- Any clinically relevant abnormal laboratory value suggesting an unknown disease and requiring further clinical investigation or which may impact the safety of the subject or the evaluation of the result of the study according to the Investigator's judgment;
- •- History of unstable cardiac disease, myocardial infarction or stroke
- •within 3 months prior to screening;
- •- Patients with known aortic aneurism;
- •- Uncontrolled hypertension or clinically relevant abnormal pulse rate;
- •- Abnormal and clinically relevant 12-lead electrocardiogram (ECG);
- •- Intake of non-permitted concomitant medications in the predefined period prior to screening or prior to randomisation or the subject is expected to take non-permitted concomitant medications during the study;
- •- Occurrence of asthma exacerbation or respiratory tract infection within 4 weeks
- •before screening or prior to randomization;
- •- Significant seasonal variation in asthma, expected during study
- •participation;
- •- History of near fatal asthma or of past hospitalisation for asthma in
- •Intensive Care unit;
- •- Diagnosis of Chronic Obstructive Lung Disease (COPD), history of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency, diagnosis of restrictive lung disease;
- •- History of hypersensitivity to any of the excipients contained in the
- •formulation used for drug administration and for other procedures in the trial;
- •- Acute bronchoconstriction induced by methacholine challenge test at
- •screening not well controlled with SABA according to investigator's opinion;
- •- Heavy caffeine drinker;
- •- Documented history of alcohol and/or drug abuse within 12 months
- •prior to screening.
研究者
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