Postmarketing Surveillance Study of Anticholinergics - Prescribing Pattern and Therapeutic Long Term Value in Patients Suffering From Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD)

September 11, 2014 updated by: Boehringer Ingelheim

Postmarketing Surveillance Study (as Per §67(6 )AMG [German Drug Law]) of Anticholinergics - Prescribing Pattern and Therapeutic Long Term Value in Patients Suffering From Moderate or Severe Chronic Obstructive Pulmonary Disease

To obtain further information on the prescribing pattern and therapeutic long term value in patients suffering from moderate or severs Chronic Obstructive Pulmonary Disease under conditions of daily practice

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

105

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 by registered pneumologists

Description

Inclusion Criteria:

  • Patients of both genders older than 40 years, who suffer from moderate or severe Chronic Obstructive Pulmonary Disease

  • Only patients who showed following diagnosis parameters were to be considered for inclusion

    • FEV1 (Forced expiratory volume in 1 second) and FEV1/VC (vital capacity) <70%
    • Reversibility FEV1 <12% in the last 6 months
    • Smoker or Ex-smoker (>10 Pack years)
    • Asthma to be excluded

Exclusion Criteria:

• Contraindications listed in the Instructions for Use/Summary of Product Characteristics

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 Pulmonary Disease
patients receiving Atrovent®
Drug: Atrovent®
Cronic Obstructive Pulmonary Disease
patients receiving Ventilat®
Drug: Ventilat®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in overall severity of the clinical picture rated on a 4-point scale
Time Frame: Up to 6 months after first study drug administration
Up to 6 months after first study drug administration
Investigator assessment of improvement of thec linical picture rated on a 6-point symptom profile
Time Frame: Up to 6 months after first study drug administration
Up to 6 months after first study drug administration

Secondary Outcome Measures

Outcome Measure
Time Frame
Assessment of efficacy by investigator on a 4-point scale
Time Frame: Up to 6 months after first study drug administration
Up to 6 months after first study drug administration
Assessment of efficacy by patient on a 4-point scale
Time Frame: Up to 6 months after first study drug administration
Up to 6 months after first study drug administration
Assessment of tolerability by investigator on a 4-point scale
Time Frame: Up to 6 months after first study drug administration
Up to 6 months after first study drug administration
Assessment of tolerability by patient on a 4-point scale
Time Frame: Up to 6 months after first study drug administration
Up to 6 months after first study drug administration
Number of patients with adverse drug reactions
Time Frame: Up to 6 months after first study drug administration
Up to 6 months after first study drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

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, 2001

Primary Completion (Actual)

September 1, 2001

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

Other Study ID Numbers

  • 244.2499

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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