Asthma, Pulmonary Disease, Chronic Obstructive
Conditions
Brief summary
The primary objective of this study was to investigate patients acceptability / preference of Berodual® Respimat® inhaler as compared to the conventional Berodual® Metered Aerosol (MA) inhaler. Ease of handling and assembling the Respimat® inhaler at home under real life conditions was also evaluated.
Interventions
DRUGBerodual® Respimat®
DRUGBerodual® MA HFA
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient's assessment of inhaler preference | Day 98 | patient preference questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rating of willingness to continue using inhaler | Day 98 | patient preference questionnaire |
| Post-dose PEFRpm (Peak expiratory flow rate) | 30 minutes post-dose up to day 98 | — |
| Rating of inhaler satisfaction | Day 49 and 98 | patient satisfaction questionnaire |
| Use of rescue medication | up to day 98 | — |
| Daytime and night-time symptom scores | up to day 98 | — |
| Retention of inhaler technique | day 49 and 98 (after 7 weeks of treatment) | proficiency questionnaire |
Outcome results
None listed