Comparison of Safety and Efficacy of Berodual® Administered Via the Respimat® Device With That Administered Via the Metered Dose Inhaler (MDI) in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Boehringer Ingelheim
Age
40–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age \>= 40 years
Diagnosis of COPD according the following criteria:
* screening FEV1\<= 65% predicted
* Screening FEV1/FVC \<= 70%
Smoking history \> 10 pack-years (a pack-year is 20 cigarettes per day for one year or equivalent
Able to be trained in the proper use of MDI and Respimat®
Able to be trained in the performance of technically satisfactory pulmonary function tests
All patients must be willing and able to sign informed consent in accordance with Good clinical Practice (GCP) and local legislation
You may not be if
History of cardiovascular, renal, neurologic, liver or endocrine dysfunction (e.g. hyperthyreosis) if they are clinically significant. A clinically significant disease is defined as one 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 or the study or the patient's ability to participate in the study
Patients with a recent (\<= one year) history of myocardial infarction
Tuberculosis with indication for treatment
History of cancer within the last five years (excluding basal carcinoma)
Patients who have undergone thoracotomy
Current psychiatric disorders
History of life-threatening pulmonary obstruction, cystic fibrosis or bronchiectasis
An upper and lower respiratory tract infection in the four weeks prior to the screening visit
Patients with known symptomatic prostatic hypertrophy or bladder neck obstruction
Patients with known narrow-angle glaucoma or raised intra-ocular pressure
Patients with clinically significant abnormal baseline haematology, blood chemistry or urinalysis, if the abnormality defines a disease listed as an exclusion criterion
Patients with:
* Serum glutamic oxalo-acetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT) \>200% of the upper limit of the normal range
* Bilirubin \>150% of the upper limit of the normal range
* Creatinine \>125% of the upper limit of the normal range
Patients who are on chronic oxygen therapy
Intolerance to aerosolised ipratropium- or fenoterol-containing products, or hypersensitivity to any of the MDI ingredients
Oral corticosteroid mediation at dose greater than 10 mg prednisolone per day or equivalent
Beta-blocker medication
Changes in the pulmonary therapeutic plan within the last four weeks prior to the screening visit (not including withholding of medication before the screening visit)
Concomitant or recent (within the last month) use of investigational drugs
History of drug abuse and/or alcoholism
Pregnant or nursing women and women of child-bearing potential not using a medically approved means of contraception
Previous participation in this study (i.e. having been allocated a randomized treatment number)
Patients with a history of asthma, allergic rhinitis or atopy or who have blood eosinophil count above 600/mm3 (a repeat eosinophil count will not be conducted in these patients) and those patients on antihistamines, anti-leukotrienes, sodium cromoglycate or nedocromil sodium
Patients who are unable to comply with the medication restrictions specified in section 4.2 or who cannot use an MDI without a spacer
Clareo Health | Comparison of Safety and Efficacy of Berodual® Administered Via the Respimat® Device With That Administered Via the Metered Dose Inhaler (MDI) in Patients With Chronic Obstructive Pulmonary Disease (COPD)
