- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02238145
Postmarketing Surveillance Study of Atrovent® Inhaletten® in Chronic Obstructive Airways Disease
September 11, 2014 updated by: Boehringer Ingelheim
Postmarketing Surveillance Study (as Per § 67 (6) AMG [German Drug Law] of Atrovent® Inhaletten® in Chronic Obstructive Airways Disease
To obtain further information on the tolerability and efficacy of Atrovent® inhaletten® in the treatment of chronic obstructive airways disease under conditions of daily practice
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
660
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
30 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with chronic obstructive airways disease recruited at general practitioners, pneumologists, internists
Description
Inclusion Criteria:
- Primarily patients of both gender, older than 30 years,who suffer from chronic obstructive airways disease
- Only patients who had not been treated with Atrovent® within the last year were to be considered for inclusion
Exclusion Criteria:
- Contraindications listed in the Instructions for Use/Summary of Product Characteristics for Atrovent® Inhaletten®
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 Airways Disease
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Investigator assessment of improvement in the clinical picture of the course on a 6-point symptoms profile
Time Frame: Up to 4 weeks after first study drug administration
|
Up to 4 weeks after first study drug administration
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Investigator assessment of tolerability on a 4-point scale
Time Frame: Up to 4 weeks after first study drug administration
|
Up to 4 weeks after first study drug administration
|
Investigator assessment of efficacy on a 4-point scale
Time Frame: Up to 4 weeks after first study drug administration
|
Up to 4 weeks after first study drug administration
|
Number of patients with adverse drug reactions
Time Frame: Up to 4 weeks after first study drug administration
|
Up to 4 weeks after first study drug administration
|
Number of patients who withdrew from the study
Time Frame: Up to 4 weeks after first study drug administration
|
Up to 4 weeks after first study drug administration
|
Number of patients who changed the concomitant medication
Time Frame: Up to 4 weeks after first study drug administration
|
Up to 4 weeks after first study drug administration
|
Number of patients who continued treatment
Time Frame: Up to 4 weeks after first study drug administration
|
Up to 4 weeks after first study drug administration
|
Patient assessment of tolerability on a 4-point scale
Time Frame: Up to 4 weeks after first study drug administration
|
Up to 4 weeks after first study drug administration
|
Patient assessment of efficacy on a 4-point scale
Time Frame: Up to 4 weeks after first study drug administration
|
Up to 4 weeks after first study 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
January 1, 1999
Primary Completion (Actual)
November 1, 1999
Study Registration Dates
First Submitted
September 11, 2014
First Submitted That Met QC Criteria
September 11, 2014
First Posted (Estimate)
September 12, 2014
Study Record Updates
Last Update Posted (Estimate)
September 12, 2014
Last Update Submitted That Met QC Criteria
September 11, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Lung Diseases
- Lung Diseases, Obstructive
- Pulmonary Disease, Chronic Obstructive
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Antagonists
- Cholinergic Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Ipratropium
Other Study ID Numbers
- 244.2492
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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