berodual® respimat® versus berodual® metered aerosol (ma) inhaler in patients with asthma, chronic obstructive pulmonary disease, or mixed condition

Conditions: Pulmonary Disease, Chronic Obstructive; Asthma

Summary: 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.


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