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)

Launched by BOEHRINGER INGELHEIM · Jun 24, 2014

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Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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