Berodual® Respimat® Solution for Inhalation in Patients With Chronic Obstructive Airways Disease

September 2, 2014 updated by: Boehringer Ingelheim

Berodual® Respimat® 20/50µg/Dose Solution for Inhalation in Patients With Chronic Obstructive Airways Disease

Tolerability, efficacy and handling of Berodual® Respimat® 20/50µg/dose solution for inhalation in patients with chronic obstructive airways disease in daily practice

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2006

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with diagnosis chronic obstructive airways disease recruited at general practitioners, internal specialists and specialists in pneumology in practice

Description

Inclusion Criteria:

  • Men and women presenting with the symptoms of chronic obstructive airways disease were given Berodual® Respimat® 20/50µg/dose solution for inhalation only where this was considered necessary in medical terms
  • Patients who have not been treated prior to the post-marketing surveillance study as well as patients who have been treated with Berodual® metered dose inhaler (MDI) or other respiratory medications prior to the Post-Marketing Surveillance Study could be included

Exclusion Criteria:

  • Patients presenting with the general and specific contraindications listed in the Patient Information Leaflet and the Basic Product Information

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 patients
Drug: Berodual® Respimat® solution for inhalation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients with adverse drug reactions
Time Frame: up to 12 weeks
up to 12 weeks
Change in overall severity of clinical picture rated on 3-point scale
Time Frame: up to 12 weeks
up to 12 weeks
Change in breathlessness rated on a 4-point scale
Time Frame: up to 12 weeks
up to 12 weeks
Change in restriction of activity due to breathlessness rated on a 4-point scale
Time Frame: up to 12 weeks
up to 12 weeks
Change in number of awakening due to nocturnal breathlessness rated on 4-point scale
Time Frame: up to 12 weeks
up to 12 weeks
Global assessment of efficacy by the patients rated on 5-point scale
Time Frame: after 4, 8 and 12 weeks
after 4, 8 and 12 weeks
Global assessment of efficacy by the investigator rated on 5-point scale
Time Frame: after 4, 8 and 12 weeks
after 4, 8 and 12 weeks
Assessment of tolerability on a 5-point scale
Time Frame: after 4, 8 and 12 weeks
after 4, 8 and 12 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, 2004

Primary Completion (Actual)

September 1, 2004

Study Registration Dates

First Submitted

September 2, 2014

First Submitted That Met QC Criteria

September 2, 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 2, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 215.1363

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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