NCT02173795已完成3 期
Berodual® Respimat® Inhaler Versus Berodual® MA Using HFA (Hydrofluoroalkane) 134a as Propellant in Adult Patients With Asthma, Chronic Obstructive Pulmonary Disease, or Mixed Conditions, an Open-label, Crossover Trial Over a 7-week Treatment Period With Each Formulation: ' A Study to Compare Patient Preference'
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 245
- 主要终点
- Patient's assessment of inhaler preference
研究概览
简要总结
The primary objective of this study was to investigate patients acceptability / preference of Berodual® Respimat® inhaler as compared to the conventional Berodual® Metered Aerosol (MA) inhaler. Ease of handling and assembling the Respimat® inhaler at home under real life conditions was also evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of chronic obstructive pulmonary disease, asthma, or mixed conditions for a minimum of 6 months
- •Male or female patients 18 years of age or older
- •Patients who use at least 2 puffs t.i.d. of Berodual® MA HFA on regular use or at least 4 weeks prior to study
- •Patients should be able to perform all study related tests including using a peak flow meter, to perform acceptable PEFR measurements, and should be able to maintain records (Patient Daily Diary Cards) during the study period as required in the protocol
- •All patients must sign and Informed Consent Form prior to participation in the trial, i.e., prior to the run-in period in accordance with International Conference on Harmonisation (ICH) Good Clinical Practice (GCP)
排除标准
- •Patients with significant disease other than chronic airways obstruction (CAO) will be excluded. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study
- •Patients with a recent history (i.e., six months - or less) of myocardial infarction
- •Patients with any cardiac arrhythmia requiring drug therapy or who have been hospitalized for heart failure within the past three years, including patients with hypertrophic cardiomyopathy and tachyarrhythmia
- •Patients who regularly use oxygen therapy
- •Patients with known active tuberculosis
- •Patients with a history of cancer within the last five years. Patients with treated basal cell carcinoma are allowed
- •Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis
- •Patients who have undergone thoracotomy with pulmonary resection. Patients with history of thoracotomy for other reasons should be evaluated as per exclusion criterion No. 1
- •Patients with any upper or lower respiratory infection in the past six weeks prior to the screening visit (Visit 1) or during the run-in period
- •Patients hospitalized or having had visits to the emergency room in the past six weeks before run-in period
- •Patients who are currently in a pulmonary rehabilitation programme that will not be maintained throughout the duration of the study or who have completed a pulmonary rehabilitation programme in the six weeks prior to the screening visit (Visit 1)
- •Patients with known hypersensitivity to anticholinergic drugs or any other components of the trial medication including excipients
- •Patients medically treated for prostatic hyperplasia or bladder neck obstruction
- •Patients with known narrow-angle glaucoma or raised intra-ocular pressure
- •Patients who are being treated with beta-blocker medications Note: beta1-blocker eye medications for treatment of non-narrow angle glaucoma are allowed
- •Patients using oral corticosteroid medication at unstable dose (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisolone per day or 20 mg every other day
- •Patients on inhaled or short-acting beta-adrenergics other than the study medication
- •Patients on inhaled or short-acting beta-anticholinergics other than the study medication
- •Patients taking monoamine oxidase inhibitors
- •Patients taking tricyclic antidepressants
- •Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception for the previous three months (i.e., oral contraceptives, intrauterine inhalers, diaphragm or subdermal implants)
- •Patients with a history of and/or active significant alcohol or drug abuse
- •Patients who have taken an investigational drug within one month or six half-lives (whichever is greater) prior to the screening visit (Visit 1)
- •Patients who have already been enrolled and randomised to a treatment group in this study
研究组 & 干预措施
Berodual® Respimat® - Berodual® MA HFA
Experimental
randomized sequence
- Berodual® Respimat® (20 µg ipratropium bromide + 50 µg fenoterol hydrobromide per actuation for 49 days)
- Berodual® MA HFA (20 µg ipratropium bromide + 50 µg fenoterol hydrobromide per puff for 49 days)
干预措施: Berodual® Respimat® (Drug)
Berodual® Respimat® - Berodual® MA HFA
Experimental
randomized sequence
- Berodual® Respimat® (20 µg ipratropium bromide + 50 µg fenoterol hydrobromide per actuation for 49 days)
- Berodual® MA HFA (20 µg ipratropium bromide + 50 µg fenoterol hydrobromide per puff for 49 days)
干预措施: Berodual® MA HFA (Drug)
结局指标
主要结局
Patient's assessment of inhaler preference
时间窗: Day 98
patient preference questionnaire
次要结局
- Rating of inhaler satisfaction(Day 49 and 98)
- Post-dose PEFRpm (Peak expiratory flow rate)(30 minutes post-dose up to day 98)
- Daytime and night-time symptom scores(up to day 98)
- Use of rescue medication(up to day 98)
- Rating of willingness to continue using inhaler(Day 98)
- Retention of inhaler technique(day 49 and 98 (after 7 weeks of treatment))
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