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

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: Berodual® Respimat® solution for inhalation

• Registration Number: NCT02231359
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Primary Completion: 2004-09
• 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: 2006

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
chronic obstructive airways disease patients	Berodual® Respimat® solution for inhalation	-

Primary Outcome Measures

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