Berodual® Respimat® Versus Berodual® Metered Aerosol (MA) Inhaler in Patients With Asthma, Chronic Obstructive Pulmonary Disease, or Mixed Condition

Launched by BOEHRINGER INGELHEIM · Jun 24, 2014

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Eligibility criteria

• Inclusion Criteria:
• • 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)
• Exclusion Criteria:
• • 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