Postmarketing Surveillance Study to Assess Handling and Patient Satisfaction on Berodual® Respimat® Solution for Inhalation in Patients With Chronic Obstructive Pulmonary Disease

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: Berodual® Respimat® - inhaler

• Registration Number: NCT02231320
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

New perceptions about handling and patient satisfaction of the everyday use of Berodual® Respimat® in patients with chronic obstructive lung disease (COLD). Moreover, further knowledge should be attained about the tolerability of Berodual® Respimat®

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12
• Primary Completion: 2006-06
• Status Verified: 2014-09
• Study First Submitted: 2014-09-02
• Study First Submitted QC: 2014-09-02
• Last Update Submitted: 2014-09-02
• Study First Posted: 2014-09-04
• Last Update Posted: 2014-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 236

Inclusion Criteria

• Male and female patients aged at least 18 years who were suffering from symptoms of a COLD (naive or pre-treated) could be included in the PMS

Exclusion Criteria

• Patients who meet one or more of the general or specific contraindications mentioned in the Summary of Product Characteristics (SmPC) are excluded from the Postmarketing Surveillance (PMS)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chronic Obstructive Pulmonary Disease patients	Berodual® Respimat® - inhaler	-

Primary Outcome Measures

Name	Time	Method
Number of patients with adverse events	up to 8 weeks
Number of patients who premature discontinued therapy with Berodual® Respimat®	up to 8 weeks

Secondary Outcome Measures

Name	Time	Method
Assessment of patient satisfaction with regard to handling of Berodual® Respimat® inhaler	up to 8 weeks	by means of patient satisfaction and preference questionnaire (PASAPQ)