Clareo Health | Berodual® Respimat® Versus Berodual® Metered Aerosol (MA) Inhaler in Patients With Asthma, Chronic Obstructive Pulmonary Disease, or Mixed Condition
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Boehringer Ingelheim
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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)
You may not be if
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
