Postmarketing Surveillance Study of Atrovent® Inhalets in Chronic Obstructive Airways Disease

Completed

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

• Registration Number: NCT02238132
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

To obtain further information on the tolerability of Atrovent® inhalets in the treatment of Chronic Obstructive Airways Disease under conditions of daily practice

Detailed Description

Not available

Study Timeline

• Study Start: 1998-12
• Primary Completion: 1999-11
• 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: 374

Inclusion Criteria

• Primarily, Patients with chronic obstructive airways disease
• Only patients who had not been treated with Atrovent® in 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 Airways Disease	ATROVENT® inhalets	-

Primary Outcome Measures

Name	Time	Method
Investigator assessment of improvement in the clinical picture of the course on a 6-point symptoms profile	Up to 4 weeks after first study drug administration

Secondary Outcome Measures

Name	Time	Method
Investigator assessment of efficacy on a 4-point scale	Up to 4 weeks after first study drug administration
Investigator assessment of tolerability on a 4-point scale	Up to 4 weeks after first study drug administration
Number of patients who continued the treatment	Up to 4 weeks after first study drug administration
Patient assessment of tolerability on a 4-point scale	Up to 4 weeks after first study drug administration
Number of patients who withdrew from the study	Up to 4 weeks after first study drug administration
Number of patients who changed the concomitant medication	Up to 4 weeks after first study drug administration
Patient assessment of efficacy on a 4-point scale	Up to 4 weeks after first study drug administration
Number of patients with adverse drug reactions	Up to 4 weeks after first study drug administration