- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02182479
Safety and Efficacy of Berodual® Respimat® Compared to Berodual® MDI (Metered Dose Inhaler) in Asthma Patients
July 11, 2014 updated by: Boehringer Ingelheim
Comparison of the Safety and Efficacy of Berodual® Administered Via Respimat® Device (50 µg Fenoterol Hydrobromide/20 µg Ipratropium Bromide and 25 µg Fenoterol Hydrobromide/10 µg Ipratropium Bromide, 1 Puff q.i.d.) With That Administered Via the MDI (50 µg Fenoterol Hydrobromide/21 µg Ipratropium Bromide, 2 Puffs q.i.d.) in Asthma Patients Over a 12-week Period
Study to demonstrate that at least one of the two doses of Berodual® (50 µg fenoterol hydrobromide/20 µg ipratropium bromide and 25 µg fenoterol hydrobromide/10 µg ipratropium bromide, 1 puff q.i.d.) administered via Respimat® gives a bronchodilator response which is not inferior to that obtained from one dose of Berodual® (50 µg fenoterol hydrobromide/21 µg ipratropium bromide, 2 puffs q.i.d.) administered via MDI and that the safety profile is at least as good in asthma patients treated for 12 weeks.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
631
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis of bronchial asthma according to the ATS (American Thoracic Society)
- Age: 18 - 65 years
- Screening FEV1: 40 - 80 % of predicted normal. Predicted normal values will be based on the guidelines for standardised function testing of the European Community for Coal and Steel
- Airway obstruction reversibility: increase in FEV1 12% from baseline and ≥ 200 ml from baseline at 30 minutes after 2 puffs of Berodual® MDI
- Current non-smoker or ex-smoker (with a smoking history of ≤ 10 pack-years) with cessation of smoking ≥ 1 year prior to the screening visit
- Male or female patients
- Ability to be trained in proper use of MDI and RESPIMAT® devices
- Ability to perform technically satisfactory pulmonary function tests
- No hospital admission for an exacerbation and stable dosage of all pulmonary medication in the last four weeks (except for long acting β2 agonists)
- Willingness and ability to sign informed consent form prior to participation in the trial
Exclusion Criteria:
- Patients with significant disease other than asthma, e.g. history of clinically significant cardiovascular, renal, neurological, hepatic or endocrine dysfunction. A clinically 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 which may influence the results of the study or the ability of the patient to participate in and complete the study
- History of myocardial infarction within the last year
- Tuberculosis with indication for treatment
- History of cancer within the last five years, excluding treated basal cell carcinoma
- Patients who have undergone thoracotomy for pulmonary resection of more than one bullae, or with subsequent impaired thoracic muscle performance leading to unsatisfactory lung function testing
- Current psychiatric disorders
- History of life threatening pulmonary obstruction, cystic fibrosis or bronchiectasis
- An upper or lower respiratory tract infection in the four weeks prior to the screening visit (= Visit 1) or during the 2-week run-in period
- Patients with clinically significant abnormal baseline haematology, blood chemistry or urinalysis, if the abnormality defines a disease listed as an exclusion criterion
- Patients with AST/ALT (aspartate amino transferase/alanine amino transferase) (SGOT/SGPT (serum glutamic oxaloacetic transaminase/serum glutamic pyruvic transaminase)) > 200%, bilirubin > 150% (except isolated bilirubin increase due to Gilbert's Syndrome), or creatinine > 125% of the upper limit of the normal range
- Intolerance to aerosolised fenoterol- or ipratropium-containing products, and/or hypersensitivity to any of the MDI ingredients
- Patients using oral corticosteroid medication at unstable (i.e. less than 4 weeks on a stable dose) or at a dose in excess of the equivalent of 10 mg prednisone per day or 20 mg every other day
- Beta-blocker medication
- Patients who have taken an investigational drug one month or six half-lives (whichever is greater) prior to the screening visit
- History of drug abuse and/or alcoholism
- Pregnant or nursing women and women of childbearing potential or less than 2 years postmenopausal, who are not using medically approved means of contraception (oral contraceptives, intra-uterine devices or surgical Sterilisation)
- Previous participation in this study
- Patients who need more than 8 puffs of salbutamol (100 µg per puff) rescue medication on 3 or more consecutive days during the run-in period
- Severe bronchial asthma with frequent nocturnal asthma attacks or acute exacerbations induced by recurrent bronchial infections several times per year
- Patients with known hypersensitivity to anticholinergic drugs
- Patients with known symptomatic prostatic hypertrophy or bladder neck obstruction
- Patients with known narrow-angle glaucoma
- Patients who did not fill in at least 80% of the diary in the run-in period for both, medication taken and peak expiratory flow rate (PEFR) measurements are considered not compliant
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Berodual® via Respimat®, high dose
|
|
Experimental: Berodual® via Respimat®, low dose
|
|
Active Comparator: Berodual® via MDI, high dose
|
|
Placebo Comparator: Placebo via Respimat®
|
|
Placebo Comparator: Placebo via MDI
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in average FEV1 (Forced expiratory volume in one second) (AUC0-6 (Area under the curve))
Time Frame: Pre-dose and 5, 15, 30, 60, 90, 120, 180, 240, 300, 360 minutes post-dose on day 1, 29, 57 and 85
|
Pre-dose and 5, 15, 30, 60, 90, 120, 180, 240, 300, 360 minutes post-dose on day 1, 29, 57 and 85
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
FEV1max
Time Frame: Pre-dose and 5, 15, 30, 60, 90, 120, 180, 240, 300, 360 minutes post-dose on day 1, 29, 57 and 85
|
Pre-dose and 5, 15, 30, 60, 90, 120, 180, 240, 300, 360 minutes post-dose on day 1, 29, 57 and 85
|
Time to onset of therapeutic response
Time Frame: Days 1, 29, 57 and 85
|
Days 1, 29, 57 and 85
|
Duration of therapeutic response
Time Frame: Days 1, 29, 57 and 85
|
Days 1, 29, 57 and 85
|
Time to peak FEV1
Time Frame: Pre-dose and 5, 15, 30, 60, 90, 120, 180, 240, 300, 360 minutes post-dose on days 1, 29, 57 and 85
|
Pre-dose and 5, 15, 30, 60, 90, 120, 180, 240, 300, 360 minutes post-dose on days 1, 29, 57 and 85
|
Change in averaged weekly morning and evening pre-dose PEFR (peak expiratory flow rate)
Time Frame: up to day 85
|
up to day 85
|
Extent of use of rescue medication
Time Frame: up to day 85
|
up to day 85
|
Change in night-time and daytime symptom scores
Time Frame: up to day 85
|
up to day 85
|
Overall incidence of adverse events
Time Frame: up to day 85
|
up to day 85
|
Number of patients with clinically significant changes in Heart rate
Time Frame: Pre-dose and 15, 30, 60, 90, 120, 180, 240, 300, 360 minutes post-dose on days 1, 29, 57 and 85
|
Pre-dose and 15, 30, 60, 90, 120, 180, 240, 300, 360 minutes post-dose on days 1, 29, 57 and 85
|
Number of patients with clinically significant changes in Blood pressure
Time Frame: Pre-dose and 15, 30, 60, 90, 120, 180, 240, 300, 360 minutes post-dose on days 1, 29, 57 and 85
|
Pre-dose and 15, 30, 60, 90, 120, 180, 240, 300, 360 minutes post-dose on days 1, 29, 57 and 85
|
Number of patients with clinically significant changes from baseline in laboratory investigations
Time Frame: Baseline and day 85
|
Baseline and day 85
|
Incidence of paradoxical bronchoconstriction
Time Frame: up to day 85
|
up to day 85
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 1998
Primary Completion (Actual)
June 1, 1999
Study Completion
December 7, 2022
Study Registration Dates
First Submitted
July 2, 2014
First Submitted That Met QC Criteria
July 7, 2014
First Posted (Estimate)
July 8, 2014
Study Record Updates
Last Update Posted (Estimate)
July 14, 2014
Last Update Submitted That Met QC Criteria
July 11, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Asthma
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Antagonists
- Cholinergic Agents
- Adrenergic Agonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Reproductive Control Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Tocolytic Agents
- Sympathomimetics
- Ipratropium
- Fenoterol
- Fenoterol, ipratropium drug combination
Other Study ID Numbers
- 215.1104
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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