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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Fenoterol; Fenoterol, ipratropium drug combination; Ipratropium

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