- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02244216
Postmarketing Surveillance Study of Berotec® N 100 µg Metered-dose Inhaler in Chronic Obstructive Respiratory Tract Disease
September 18, 2014 updated by: Boehringer Ingelheim
Postmarketing Surveillance Study (as Per § 67 (6) AMG [German Drug Law]) of Berotec® N 100 µg Metered-dose Inhaler in Chronic Obstructive Respiratory Tract Disease
Study to obtain data about changing from the chlorofluorocarbon (CFC) - containing Berotec® 200 µg metered - dose inhaler to the CFC - free Berotec® N 100 µg metered - dose inhaler
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
2914
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
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patinet with chronic obstructive respiratory tract disease recruited at general practitioners, pneumologists, internists
Description
Inclusion Criteria:
- Patients were included in the study only if they had been treated with Berotec® 200 µg metered - dose inhaler before switching to the CFC-free Berotec® N 100 µg metered - dose inhaler
Exclusion Criteria:
• Contraindications listed in the Instructions for Use/Summary of Product Characteristics for Berotec® N 100 µg 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in the clinical picture of chronic obstructive airways disease on switching from Berotec® 200 µg to Berotec® N 100 µg
Time Frame: After 3 weeks of first drug administration
|
After 3 weeks of first drug administration
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Investigator assessment of efficacy on a 4-point scale
Time Frame: Up to 3 weeks after first drug administration
|
Up to 3 weeks after first drug administration
|
Patient assessment of efficacy on a 4-point scale
Time Frame: Up to 3 weeks after first drug administration
|
Up to 3 weeks after first drug administration
|
Patient assessment of tolerability on a 4-point scale
Time Frame: Up to 3 weeks after first drug administration
|
Up to 3 weeks after first drug administration
|
Investigator comparative overall assessment on a 4-point scale
Time Frame: After 3 weeks of first drug administration
|
After 3 weeks of first drug administration
|
Number of patients with adverse drug reactions
Time Frame: Up to 3 weeks after first drug administration
|
Up to 3 weeks after first drug administration
|
Number of patients who changed the concomitant medication
Time Frame: Up to 3 weeks after first drug administration
|
Up to 3 weeks after first drug administration
|
Number of patients who continued treatment
Time Frame: Up to 3 weeks after first drug administration
|
Up to 3 weeks after first drug administration
|
Number of patients who premature withdrew from the treatment
Time Frame: Up to 3 weeks after first drug administration
|
Up to 3 weeks after first drug administration
|
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, 2000
Primary Completion (ACTUAL)
June 1, 2000
Study Registration Dates
First Submitted
September 18, 2014
First Submitted That Met QC Criteria
September 18, 2014
First Posted (ESTIMATE)
September 19, 2014
Study Record Updates
Last Update Posted (ESTIMATE)
September 19, 2014
Last Update Submitted That Met QC Criteria
September 18, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Lung Diseases
- Lung Diseases, Obstructive
- Pulmonary Disease, Chronic Obstructive
- Respiratory Tract Diseases
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System 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
- Fenoterol
Other Study ID Numbers
- 260.3178
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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