Postmarketing Surveillance Study of Atrovent® in Chronic Obstructive Airways Disease

Completed

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

• Registration Number: NCT02236715
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Study to obtain further information on the tolerability and efficacy of Atrovent® unit dose vial 500 µg in the treatment of Chronic Obstructive Airways Disease under conditions of daily practice

Detailed Description

Not available

Study Timeline

• Study Start: 1999-09
• Primary Completion: 2000-02
• Status Verified: 2014-09
• Study First Submitted: 2014-09-10
• Study First Submitted QC: 2014-09-10
• Last Update Submitted: 2014-09-10
• Study First Posted: 2014-09-11
• Last Update Posted: 2014-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1039

Inclusion Criteria

• Primarily patients of both gender, older than 30 years, who suffer from chronic obstructive airways disease
• Only patients who had not been treated with Atrovent® within the last year were to be considered for inclusion

Exclusion Criteria

• Contraindication listed in the instructions for use/summary of product characteristics for Atrovent® unit dose vial 500 µg

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chronic Obstructive Airways Disease	Atrovent®	-

Primary Outcome Measures

Name	Time	Method
Change in total severity of the clinical picture rated on a 4-point scale	after 4 weeks

Secondary Outcome Measures

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