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

Postmarketing Surveillance Study (as Per § 67 (6) AMG [German Drug Law] of Atrovent® Inhaletten® in Chronic Obstructive Airways Disease

To obtain further information on the tolerability and efficacy of Atrovent® inhaletten® in the treatment of chronic obstructive airways disease under conditions of daily practice

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Drug: Atrovent® Inhaletten

• Study Type: Observational
• Enrollment (Actual): 660

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic obstructive airways disease recruited at general practitioners, pneumologists, internists

Description

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:

- Contraindications listed in the Instructions for Use/Summary of Product Characteristics for Atrovent® Inhaletten®

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Chronic Obstructive Airways Disease	Drug: Atrovent® Inhaletten

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Investigator assessment of tolerability on a 4-point scale	Up to 4 weeks after first study drug administration
Investigator 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
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
Number of patients who continued 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
Patient assessment of efficacy on a 4-point scale	Up to 4 weeks after first study drug administration

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: January 1, 1999
• Primary Completion (Actual): November 1, 1999

Study Registration Dates

• First Submitted: September 11, 2014
• First Submitted That Met QC Criteria: September 11, 2014
• First Posted (Estimate): September 12, 2014

Study Record Updates

• Last Update Posted (Estimate): September 12, 2014
• Last Update Submitted That Met QC Criteria: September 11, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Ipratropium
• Other Study ID Numbers: 244.2492