Post-marketing Surveillance of Atrovent® in Chronic Obstructive Pulmonary Disease

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: Atrovent® - inhalets

• Registration Number: NCT02233881
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Study to obtain further information on the tolerability and efficacy of Atrovent® inhalets in the treatment of Chronic Obstructive Pulmonary Disease under conditions of daily practice

Detailed Description

Not available

Study Timeline

• Study Start: 2001-01
• Primary Completion: 2001-11
• Status Verified: 2014-09
• Study First Submitted: 2014-09-08
• Study First Submitted QC: 2014-09-08
• Last Update Submitted: 2014-09-08
• Study First Posted: 2014-09-09
• Last Update Posted: 2014-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4222

Inclusion Criteria

• Patients of both gender older than 40 years, who suffer from Chronic Obstructive Pulmonary Disease
• Only patients who have not been treated with Atrovent® within the last year are to be considered for inclusion

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chronic obstructive pulmonary disease patients	Atrovent® - inhalets	-

Primary Outcome Measures

Name	Time	Method
Change in the clinical picture	after 4 weeks

Secondary Outcome Measures

Name	Time	Method
Assessment of efficacy by investigator on a 4-point scale	after 4 weeks
Assessment of efficacy by patient on a 4-point scale	after 4 weeks
Number of patients with adverse drug reactions	up to 4 weeks
Assessment of tolerability by patient on a 4-point scale	after 4 weeks
Assessment of tolerability by investigator on a 4-point scale	after 4 weeks