- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02231437
Post-marketing Surveillance of Berodual® Metered-dose Inhaler in the Treatment of Chronic Obstructive Respiratory Tract Disease
September 1, 2014 updated by: Boehringer Ingelheim
Post-marketing Surveillance (in Accordance With § 67,6 AMG) of Berodual® Metered-dose Inhaler in the Treatment of Chronic Obstructive Respiratory Tract Disease
The aim of this post-marketing surveillance is to obtain further information about the tolerability of Berodual® metered-dose inhaler in the treatment of chronic obstructive respiratory tract disease under conditions of daily practice
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
3488
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
6 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
general practitioners, pneumologists and internists
Description
Inclusion Criteria:
- Patients with diagnosis of Chronic obstructive respiratory tract disease
- Patients of either sex, including children over 6 years
Exclusion Criteria:
- Contraindications listed in the Instructions of Use/Summary of Product Characteristics of Berodual® metered-dose inhaler
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
chronic obstructive respiratory tract disease patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall severity of the clinical picture rated on a 4-point scale
Time Frame: after 3 and 6 weeks
|
after 3 and 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of patients with adverse drug reactions
Time Frame: up to 6 weeks
|
up to 6 weeks
|
Changes in dyspnea and/or asthma attacks rated on a 4-point scale
Time Frame: after 3 and 6 weeks
|
after 3 and 6 weeks
|
Number of dyspnea episodes rated on a 4-point scale
Time Frame: after 3 and 6 weeks
|
after 3 and 6 weeks
|
Number of awakenings due to night-time dyspnea rated on a 4-point scale
Time Frame: after 3 and 6 weeks
|
after 3 and 6 weeks
|
Assessment of tolerability on a 4-point scale
Time Frame: after 3 and 6 weeks
|
after 3 and 6 weeks
|
Changes in pathological auscultation findings rated on a 3-point scale
Time Frame: after 3 and 6 weeks
|
after 3 and 6 weeks
|
Changes in concomitant medication
Time Frame: up to 6 weeks
|
up to 6 weeks
|
Assessment of efficacy on a 4-point scale
Time Frame: after 3 and 6 weeks
|
after 3 and 6 weeks
|
Assessment of morning coughing with expectoration on a 4-point scale
Time Frame: after 3 and 6 weeks
|
after 3 and 6 weeks
|
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
January 1, 1999
Primary Completion (Actual)
November 1, 1999
Study Registration Dates
First Submitted
September 1, 2014
First Submitted That Met QC Criteria
September 1, 2014
First Posted (Estimate)
September 4, 2014
Study Record Updates
Last Update Posted (Estimate)
September 4, 2014
Last Update Submitted That Met QC Criteria
September 1, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 215.1352
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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