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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02232594
Other study ID # 215.1358
Secondary ID
Status Completed
Phase N/A
First received September 4, 2014
Last updated September 4, 2014
Start date January 2000

Study information

Verified date September 2014
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Observational

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 834
Est. completion date
Est. primary completion date December 2000
Accepts healthy volunteers No
Gender Both
Age group 40 Years and older
Eligibility Inclusion Criteria:

- Patients of either sex over 40 years with the symptoms of a chronic obstructive airways disease

- Only patients which have not been treated with Berodual® within the last year should be included

Exclusion Criteria:

- Contraindications listed in the Instructions for Use/Summary of Product Characteristics for Berodual® metered-dose inhaler

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Drug:
Berodual®


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Boehringer Ingelheim

Outcome

Type Measure Description Time frame Safety issue
Primary Overall severity of the clinical picture rated on a 4- point scale after 3 and 6 weeks No
Secondary Assessment of efficacy by investigator on a 4-point scale after 3 and 6 weeks No
Secondary Assessment of efficacy by patient on a 4-point scale after 3 and 6 weeks No
Secondary Assessment of tolerability by investigator on a 4-point scale after 3 and 6 weeks No
Secondary Assessment of tolerability by patient on a 4-point scale after 3 and 6 weeks No
Secondary Number of patients with adverse drug reactions up to 6 weeks No
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