Post-marketing Surveillance of Berodual® Metered-dose Inhaler in the Treatment of Chronic Obstructive Respiratory Tract Disease

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

Post-marketing Surveillance (in Accordance With § 67,6 AMG) of Berodual® Metered-dose Inhaler in the Treatment of Chronic Obstructive Respiratory Tract Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02231437
• Other study ID #: 215.1352
• Status: Completed
• Phase: Phase 4
• First received: September 1, 2014
• Last updated: September 1, 2014
• Start date: January 1999

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 post-marketing surveillance is to obtain further information about the tolerability 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: 3488
• Est. primary completion date: November 1999
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years and older

Eligibility

Inclusion Criteria:

• Patients with diagnosis of Chronic obstructive respiratory tract disease

• Patients of either sex, including children over 6 years

Exclusion Criteria:

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Disease
• Pulmonary Disease, Chronic Obstructive
• Respiratory Tract Diseases

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	Changes in dyspnea and/or asthma attacks rated on a 4-point scale		after 3 and 6 weeks	No
Secondary	Number of dyspnea episodes rated on a 4-point scale		after 3 and 6 weeks	No
Secondary	Number of awakenings due to night-time dyspnea rated on a 4-point scale		after 3 and 6 weeks	No
Secondary	Assessment of morning coughing with expectoration on a 4-point scale		after 3 and 6 weeks	No
Secondary	Assessment of tolerability on a 4-point scale		after 3 and 6 weeks	No
Secondary	Number of patients with adverse drug reactions		up to 6 weeks	No
Secondary	Changes in pathological auscultation findings rated on a 3-point scale		after 3 and 6 weeks	No
Secondary	Changes in concomitant medication		up to 6 weeks	No
Secondary	Assessment of efficacy on a 4-point scale		after 3 and 6 weeks	No

External Links

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