berodual® respimat® vs metered dose inhaler in patients with chronic obstructive pulmonary disease

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: study to compare the effect of 'natural' as opposed to 'optimal' technique on the percentage of the dose received from the respimat® inhaler and metered dose inhaler


Eligibility criteria:
inclusion criteria: * all patients must have a diagnosis of copd and must meet the following spirometric criteria: * patients must have relatively stable, mild to severe airway obstruction with an forced expiratory volulme in one second (fev1) ≤70% of predicted normal and fev1 ≤70% of forced vital capacity (fvc). predicted normal values calculated according to evolutionary conserved chromosome segments (eccs) * patients who have frequent exacerbations which could be expected to interfere with the patient's ability to participate in the study should be excluded * male or non-pregnant/non-lactating female patients aged ≥18 years * patients must demonstrate poor mdi technique prior to the start of the study. presence of any of the following will be considered poor technique: * failure to co-ordinate "firing" of an mdi with inhalation * too fast an inhalation rate (\> 30 litres/minute (l/min)) * presence of "cold freon" effect (mdi spray hitting the back of the throat that caused the patient to stop inhaling) * all patients must sign an informed consent form prior to participation in the study, i.e. prior to pre-study washout of their usual pulmonary medications * current or ex-smokers with a smoking history of \>10 pack years exclusion criteria: * patients with significant diseases other than copd 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 clinically relevant abnormal baseline haematology, blood chemistry or urinalysis, if the abnormality defines a disease listed as an exclusion criterion will be excluded * patients with a recent history (i.e. six months or less) of myocardial infarction * patients with any unstable or life-threatening cardiac arrhythmia or who have been hospitalised for heart failure within the past year * patients who regularly use daytime oxygen therapy for more than 1 hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen * 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 bronchiectasis * patients who have undergone thoracotomy with pulmonary resection. patients with a history of thoracotomy for other reasons should be evaluated as per exclusion 1 * patients with any upper respiratory infection in the past 14 days prior to the screening visit or during the baseline period * patients who are currently in a pulmonary rehabilitation programme or who have completed a pulmonary rehabilitation programme in the six weeks prior to the screening visit * patients with known hypersensitivity to β2-agonists, anticholinergic drugs or any excipients of the active or placebo berodual® * patients with known narrow-angle glaucoma * patients who are being treated with antihistamines (h1 receptor antagonists) * patients using oral corticosteroid medication at unstable doses (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 who are being treated with monamine oxidase inhibitors or tricyclic antidepressants * pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e. oral or injectable eg depo-provera or noristerat contraceptives, intrauterine devices, diaphragm (plus spermicide) or subdermal implants eg: norplant®) * patients with, in the opinion of the investigator, a history of and/or active significant alcohol or drug abuse * patients who have taken an investigational drug within four months or six half lives (whichever is the greater) prior to screening visit and/or the administration of radiolabelled dosage forms within the three months prior to the screening visit * radiation exposure from clinical studies, including that from the present study and diagnostic x-rays but excluding background radiation, exceeding 5 millisievert (msv) in the last 12 months or 10 msv in the last five years. no patient whose occupational exposure is monitored will participate in the study precautions: as with other anticholinergic drugs, berodual® should be used with caution in patients with prostatic hyperplasia or bladder neck obstruction.