Postmarketing Surveillance Study of Berotec® N 100 µg Metered-dose Inhaler in Chronic Obstructive Respiratory Tract Disease

September 18, 2014 updated by: Boehringer Ingelheim

Postmarketing Surveillance Study (as Per § 67 (6) AMG [German Drug Law]) of Berotec® N 100 µg Metered-dose Inhaler in Chronic Obstructive Respiratory Tract Disease

Study to obtain data about changing from the chlorofluorocarbon (CFC) - containing Berotec® 200 µg metered - dose inhaler to the CFC - free Berotec® N 100 µg metered - dose inhaler

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2914

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patinet with chronic obstructive respiratory tract disease recruited at general practitioners, pneumologists, internists

Description

Inclusion Criteria:

  • Patients were included in the study only if they had been treated with Berotec® 200 µg metered - dose inhaler before switching to the CFC-free Berotec® N 100 µg metered - dose inhaler

Exclusion Criteria:

• Contraindications listed in the Instructions for Use/Summary of Product Characteristics for Berotec® N 100 µg 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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Chronic Obstructive Respiratory Tract Disease
Drug: Berotec® N 100 µg Metered-dose Inhaler

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in the clinical picture of chronic obstructive airways disease on switching from Berotec® 200 µg to Berotec® N 100 µg
Time Frame: After 3 weeks of first drug administration
After 3 weeks of first drug administration

Secondary Outcome Measures

Outcome Measure
Time Frame
Investigator assessment of efficacy on a 4-point scale
Time Frame: Up to 3 weeks after first drug administration
Up to 3 weeks after first drug administration
Patient assessment of efficacy on a 4-point scale
Time Frame: Up to 3 weeks after first drug administration
Up to 3 weeks after first drug administration
Patient assessment of tolerability on a 4-point scale
Time Frame: Up to 3 weeks after first drug administration
Up to 3 weeks after first drug administration
Investigator comparative overall assessment on a 4-point scale
Time Frame: After 3 weeks of first drug administration
After 3 weeks of first drug administration
Number of patients with adverse drug reactions
Time Frame: Up to 3 weeks after first drug administration
Up to 3 weeks after first drug administration
Number of patients who changed the concomitant medication
Time Frame: Up to 3 weeks after first drug administration
Up to 3 weeks after first drug administration
Number of patients who continued treatment
Time Frame: Up to 3 weeks after first drug administration
Up to 3 weeks after first drug administration
Number of patients who premature withdrew from the treatment
Time Frame: Up to 3 weeks after first drug administration
Up to 3 weeks after first 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

April 1, 2000

Primary Completion (ACTUAL)

June 1, 2000

Study Registration Dates

First Submitted

September 18, 2014

First Submitted That Met QC Criteria

September 18, 2014

First Posted (ESTIMATE)

September 19, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

September 19, 2014

Last Update Submitted That Met QC Criteria

September 18, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 260.3178

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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