- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02238171
Postmarketing Surveillance Study of Atrovent® Inhalets in Chronic Obstructive Pulmonary Disease
September 11, 2014 updated by: Boehringer Ingelheim
Postmarketing Surveillance Study (as Per §67(6)AMG [German Drug Law]) of Atrovent® Inhalets in Chronic Obstructive Pulmonary Disease
To obtain further information on the tolerability and efficacy of Atrovent® inhalets in the treatment of Chronic Obstructive Pulmonary Disease under conditions of daily practice
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
346
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
40 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:
- Patients of both gender, older than 40 years, who suffer from chronic obstructive Pulmonary 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® Inhalets
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
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Chronic Obstructive Pulmonary Disease
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Investigator assessment of improvement of the clinical picture rated on a 6-point symptom profile
Time Frame: Up to 4 weeks after first drug administration
|
Up to 4 weeks after first drug administration
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Assessment of efficacy by investigator on a 4-point scale
Time Frame: Up to 4 weeks after first drug administration
|
Up to 4 weeks after first drug administration
|
Assessment of efficacy by patient on a 4-point scale
Time Frame: Up to 4 weeks after first drug administration
|
Up to 4 weeks after first drug administration
|
Assessment of tolerability by investigator on a 4-point scale
Time Frame: Up to 4 weeks after first drug administration
|
Up to 4 weeks after first drug administration
|
Assessment of tolerability by patient on a 4-point scale
Time Frame: Up to 4 weeks after first drug administration
|
Up to 4 weeks after first drug administration
|
Number of patients with adverse drug reactions
Time Frame: Up to 4 weeks after first drug administration
|
Up to 4 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)
December 1, 2000
Study Completion
December 7, 2022
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
- 244.2497
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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