MedPath

Postmarketing Surveillance Study of Atrovent® in Chronic Obstructive Airways Disease

Completed
Conditions
Pulmonary Disease, Chronic Obstructive
Interventions
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

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
GroupInterventionDescription
Chronic Obstructive Airways DiseaseAtrovent®-
Primary Outcome Measures
NameTimeMethod
Change in total severity of the clinical picture rated on a 4-point scaleafter 4 weeks
Secondary Outcome Measures
NameTimeMethod
Assessment of efficacy by patient on a 4-point scaleafter 4 weeks
Assessment of tolerability by patient on a 4-point scaleafter 4 weeks
Number of patients with adverse drug reactionsup to 4 weeks
Assessment of efficacy by investigator on a 4-point scaleafter 4 weeks
Assessment of tolerability by investigator on a 4-point scaleafter 4 weeks
© Copyright 2025. All Rights Reserved by MedPath