Berodual® Respimat® Versus Berodual® Metered Aerosol (MA) Inhaler in Patients With Asthma, Chronic Obstructive Pulmonary Disease, or Mixed Condition
Primary Purpose
Pulmonary Disease, Chronic Obstructive, Asthma
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Berodual® Respimat®
Berodual® MA HFA
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Berodual® Respimat® - Berodual® MA HFA
Arm Description
randomized sequence Berodual® Respimat® (20 µg ipratropium bromide + 50 µg fenoterol hydrobromide per actuation for 49 days) Berodual® MA HFA (20 µg ipratropium bromide + 50 µg fenoterol hydrobromide per puff for 49 days)
Outcomes
Primary Outcome Measures
Patient's assessment of inhaler preference
patient preference questionnaire
Secondary Outcome Measures
Rating of inhaler satisfaction
patient satisfaction questionnaire
Rating of willingness to continue using inhaler
patient preference questionnaire
Post-dose PEFRpm (Peak expiratory flow rate)
Retention of inhaler technique
proficiency questionnaire
Use of rescue medication
Daytime and night-time symptom scores
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02173795
Brief Title
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
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
June 2003 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive, Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
245 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Berodual® Respimat® - Berodual® MA HFA
Arm Type
Experimental
Arm Description
randomized sequence
Berodual® Respimat® (20 µg ipratropium bromide + 50 µg fenoterol hydrobromide per actuation for 49 days)
Berodual® MA HFA (20 µg ipratropium bromide + 50 µg fenoterol hydrobromide per puff for 49 days)
Intervention Type
Drug
Intervention Name(s)
Berodual® Respimat®
Intervention Type
Drug
Intervention Name(s)
Berodual® MA HFA
Primary Outcome Measure Information:
Title
Patient's assessment of inhaler preference
Description
patient preference questionnaire
Time Frame
Day 98
Secondary Outcome Measure Information:
Title
Rating of inhaler satisfaction
Description
patient satisfaction questionnaire
Time Frame
Day 49 and 98
Title
Rating of willingness to continue using inhaler
Description
patient preference questionnaire
Time Frame
Day 98
Title
Post-dose PEFRpm (Peak expiratory flow rate)
Time Frame
30 minutes post-dose up to day 98
Title
Retention of inhaler technique
Description
proficiency questionnaire
Time Frame
day 49 and 98 (after 7 weeks of treatment)
Title
Use of rescue medication
Time Frame
up to day 98
Title
Daytime and night-time symptom scores
Time Frame
up to day 98
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/215/215.1357_U03-1912.pdf
Description
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Berodual® Respimat® Versus Berodual® Metered Aerosol (MA) Inhaler in Patients With Asthma, Chronic Obstructive Pulmonary Disease, or Mixed Condition
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