Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Boehringer Ingelheim
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Diagnosis of bronchial asthma according to the ATS (American Thoracic Society)
Age: 18 - 65 years
Screening FEV1: 40 - 80 % of predicted normal. Predicted normal values will be based on the guidelines for standardised function testing of the European Community for Coal and Steel
Airway obstruction reversibility: increase in FEV1 12% from baseline and ≥ 200 ml from baseline at 30 minutes after 2 puffs of Berodual® MDI
Current non-smoker or ex-smoker (with a smoking history of ≤ 10 pack-years) with cessation of smoking ≥ 1 year prior to the screening visit
Male or female patients
Ability to be trained in proper use of MDI and RESPIMAT® devices
Ability to perform technically satisfactory pulmonary function tests
No hospital admission for an exacerbation and stable dosage of all pulmonary medication in the last four weeks (except for long acting β2 agonists)
Willingness and ability to sign informed consent form prior to participation in the trial
You may not be if
Patients with significant disease other than asthma, e.g. history of clinically significant cardiovascular, renal, neurological, hepatic or endocrine dysfunction. A clinically 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 which may influence the results of the study or the ability of the patient to participate in and complete the study
History of myocardial infarction within the last year
Tuberculosis with indication for treatment
History of cancer within the last five years, excluding treated basal cell carcinoma
Patients who have undergone thoracotomy for pulmonary resection of more than one bullae, or with subsequent impaired thoracic muscle performance leading to unsatisfactory lung function testing
Current psychiatric disorders
History of life threatening pulmonary obstruction, cystic fibrosis or bronchiectasis
An upper or lower respiratory tract infection in the four weeks prior to the screening visit (= Visit 1) or during the 2-week run-in period
Patients with clinically significant abnormal baseline haematology, blood chemistry or urinalysis, if the abnormality defines a disease listed as an exclusion criterion
Patients with AST/ALT (aspartate amino transferase/alanine amino transferase) (SGOT/SGPT (serum glutamic oxaloacetic transaminase/serum glutamic pyruvic transaminase)) \> 200%, bilirubin \> 150% (except isolated bilirubin increase due to Gilbert's Syndrome), or creatinine \> 125% of the upper limit of the normal range
Intolerance to aerosolised fenoterol- or ipratropium-containing products, and/or hypersensitivity to any of the MDI ingredients
Patients using oral corticosteroid medication at unstable (i.e. less than 4 weeks on a stable dose) or at a dose in excess of the equivalent of 10 mg prednisone per day or 20 mg every other day
Beta-blocker medication
Patients who have taken an investigational drug one month or six half-lives (whichever is greater) prior to the screening visit
History of drug abuse and/or alcoholism
Pregnant or nursing women and women of childbearing potential or less than 2 years postmenopausal, who are not using medically approved means of contraception (oral contraceptives, intra-uterine devices or surgical Sterilisation)
Previous participation in this study
Patients who need more than 8 puffs of salbutamol (100 µg per puff) rescue medication on 3 or more consecutive days during the run-in period
Severe bronchial asthma with frequent nocturnal asthma attacks or acute exacerbations induced by recurrent bronchial infections several times per year
Patients with known hypersensitivity to anticholinergic drugs
Patients with known symptomatic prostatic hypertrophy or bladder neck obstruction
Patients with known narrow-angle glaucoma
Patients who did not fill in at least 80% of the diary in the run-in period for both, medication taken and peak expiratory flow rate (PEFR) measurements are considered not compliant
Clareo Health | Safety and Efficacy of Berodual® Respimat® Compared to Berodual® MDI (Metered Dose Inhaler) in Asthma Patients
