Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2026-02-21 @ 10:01 PM
Study NCT ID:
NCT02173795
Status:
COMPLETED
Last Update Posted:
2014-07-14
First Post:
2014-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Berodual® Respimat® Versus Berodual® Metered Aerosol (MA) Inhaler in Patients With Asthma, Chronic Obstructive Pulmonary Disease, or Mixed Condition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 245}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'lastUpdateSubmitDate': '2014-07-11', 'studyFirstSubmitDate': '2014-06-24', 'studyFirstSubmitQcDate': '2014-06-24', 'lastUpdatePostDateStruct': {'date': '2014-07-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Patient's assessment of inhaler preference", 'timeFrame': 'Day 98', 'description': 'patient preference questionnaire'}], 'secondaryOutcomes': [{'measure': 'Rating of inhaler satisfaction', 'timeFrame': 'Day 49 and 98', 'description': 'patient satisfaction questionnaire'}, {'measure': 'Rating of willingness to continue using inhaler', 'timeFrame': 'Day 98', 'description': 'patient preference questionnaire'}, {'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)', 'description': 'proficiency questionnaire'}, {'measure': 'Use of rescue medication', 'timeFrame': 'up to day 98'}, {'measure': 'Daytime and night-time symptom scores', 'timeFrame': 'up to day 98'}]}, 'conditionsModule': {'conditions': ['Pulmonary Disease, Chronic Obstructive', 'Asthma']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of chronic obstructive pulmonary disease, asthma, or mixed conditions for a minimum of 6 months\n* Male or female patients 18 years of age or older\n* 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\n* 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\n* 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)\n\nExclusion Criteria:\n\n* 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\n* Patients with a recent history (i.e., six months - or less) of myocardial infarction\n* 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\n* Patients who regularly use oxygen therapy\n* Patients with known active tuberculosis\n* Patients with a history of cancer within the last five years. Patients with treated basal cell carcinoma are allowed\n* Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis\n* 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\n* 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\n* Patients hospitalized or having had visits to the emergency room in the past six weeks before run-in period\n* 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)\n* Patients with known hypersensitivity to anticholinergic drugs or any other components of the trial medication including excipients\n* Patients medically treated for prostatic hyperplasia or bladder neck obstruction\n* Patients with known narrow-angle glaucoma or raised intra-ocular pressure\n* Patients who are being treated with beta-blocker medications Note: beta1-blocker eye medications for treatment of non-narrow angle glaucoma are allowed\n* 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\n* Patients on inhaled or short-acting beta-adrenergics other than the study medication\n* Patients on inhaled or short-acting beta-anticholinergics other than the study medication\n* Patients taking monoamine oxidase inhibitors\n* Patients taking tricyclic antidepressants\n* 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)\n* Patients with a history of and/or active significant alcohol or drug abuse\n* Patients who have taken an investigational drug within one month or six half-lives (whichever is greater) prior to the screening visit (Visit 1)\n* Patients who have already been enrolled and randomised to a treatment group in this study"}, 'identificationModule': {'nctId': 'NCT02173795', 'briefTitle': 'Berodual® Respimat® Versus Berodual® Metered Aerosol (MA) Inhaler in Patients With Asthma, Chronic Obstructive Pulmonary Disease, or Mixed Condition', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': "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'", 'orgStudyIdInfo': {'id': '215.1357'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Berodual® Respimat® - Berodual® MA HFA', 'description': 'randomized sequence\n\n1. Berodual® Respimat® (20 µg ipratropium bromide + 50 µg fenoterol hydrobromide per actuation for 49 days)\n2. Berodual® MA HFA (20 µg ipratropium bromide + 50 µg fenoterol hydrobromide per puff for 49 days)', 'interventionNames': ['Drug: Berodual® Respimat®', 'Drug: Berodual® MA HFA']}], 'interventions': [{'name': 'Berodual® Respimat®', 'type': 'DRUG', 'armGroupLabels': ['Berodual® Respimat® - Berodual® MA HFA']}, {'name': 'Berodual® MA HFA', 'type': 'DRUG', 'armGroupLabels': ['Berodual® Respimat® - Berodual® MA HFA']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}