Postmarketing Surveillance of Atrovent® in Chronic Obstructive Pulmonary Disease

Completed

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

• Registration Number: NCT02238158
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 1999-09
• Primary Completion: 2001-04
• Status Verified: 2014-09
• Study First Submitted: 2014-09-11
• Study First Submitted QC: 2014-09-11
• Last Update Submitted: 2014-09-11
• Study First Posted: 2014-09-12
• Last Update Posted: 2014-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 595

Inclusion Criteria

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

Exclusion Criteria

• Contraindications listed in the Instructions for Use/Summary of Product Characteristics for Atrovent® Inhalets

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chronic Obstructive Pulmonary Disease	Atrovent® inhalets	-

Primary Outcome Measures

Name	Time	Method
Investigator assessment of improvement of the clinical picture rated on a 6-point symptom profile	Up to 12 months after first study drug administration

Secondary Outcome Measures

Name	Time	Method
Assessment of tolerability by patient on a 4-point scale	Up to 12 months after first study drug administration
Number of patients with adverse drug reactions	Up to 12 months after first study drug administration
Assessment of tolerability by investigator on a 4-point scale	Up to 12 months after first study drug administration
Assessment of efficacy by investigator on a 4-point scale	Up to 12 months after first study drug administration
Assessment of efficacy by patient on a 4-point scale	Up to 12 months after first study drug administration