Clinical trial NCT02173795: Berodual® Respimat® Versus Berodual® Metered Aerosol (MA) Inhaler in Patients With Asthma, Chronic Obstructive Pulmonary Disease, or Mixed Condition
Official title: Berodual® Respimat® Inhaler Versus Berodual® MA Using HFA (Hydrofluoroalkane) 134a as Propellant in Adult Patients With Asthma, Chronic Obstructive Pulmonary Disease, or Mixed Conditions, an Open-label, Crossover Trial Over a 7-week Treatment Period With Each Formulation: ' A Study to Compare Patient Preference'
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Disease, Chronic Obstructive
Asthma
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-06-25
Enrollment: 245
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Patient's assessment of inhaler preference
timeFrame: Day 98
Secondary outcomes:
measure: Rating of inhaler satisfaction
timeFrame: Day 49 and 98
measure: Rating of willingness to continue using inhaler
timeFrame: Day 98
measure: Post-dose PEFRpm (Peak expiratory flow rate)
timeFrame: 30 minutes post-dose up to day 98
measure: Retention of inhaler technique
timeFrame: day 49 and 98 (after 7 weeks of treatment)
measure: Use of rescue medication
timeFrame: up to day 98
measure: Daytime and night-time symptom scores
timeFrame: up to day 98
Other outcomes:
Locations:
Study officials:
References: