Postmarketing Surveillance Study of Berodual® Metered-dose Inhaler in Chronic Obstructive Airways Disease

September 1, 2014 updated by: Boehringer Ingelheim

Postmarketing Surveillance Study (as Per § 67 (6) AMG [German Drug Law]) of Berodual® Metered-dose Inhaler in Chronic Obstructive Airways Disease

The aim of this postmarketing surveillance is to obtain further information about the tolerability and efficacy 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)

713

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

Patients with diagnosis of chronic obstructive respiratory tract disease

Description

Inclusion Criteria:

  • Patients of either sex, including children over 6 years
  • Chronic obstructive respiratory tract disease. Every doctor was asked to include in this study the first patients coming after each other, who were treated for the first time with Berodual® metered dose inhaler (MDI)

Exclusion Criteria:

  • Contraindications listed in the Instructions for 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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
chronic obstructive respiratory tract disease patients
Drug: Drug: Berodual®

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 morning coughing with expectoration 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

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, 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

  • 215.1353

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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