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Post-marketing Surveillance of Ventilat® in Long-term Therapy in Chronic Obstructive Pulmonary Disease

Completed
Conditions
Pulmonary Disease, Chronic Obstructive
Interventions
Registration Number
NCT02233907
Lead Sponsor
Boehringer Ingelheim
Brief Summary

Study to obtain further information on the tolerability and efficacy of Ventilat® metered dose inhaler in long-term treatment of Chronic Obstructive Pulmonary Disease under conditions of daily practice

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
595
Inclusion Criteria
  • Patients of both genders older than 40 years, who suffer from Chronic Obstructive Pulmonary Disease
  • Only patients who have not been treated with Ventilat® within the last year are to be considered for inclusion
Exclusion Criteria
  • Contraindications listed in the Instructions for Use/Summary of Product Characteristics for Ventilat® metered dose inhaler

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Chronic obstructive pulmonary disease patientsVentilat® - metered dose inhaler-
Primary Outcome Measures
NameTimeMethod
Change in the clinical pictureup to 12 months
Secondary Outcome Measures
NameTimeMethod
Assessment of efficacy by patient on a 4-point scaleafter 12 months
Assessment of efficacy by investigator on a 4-point scaleafter 12 months
Assessment of tolerability by investigator on a 4-point scaleafter 12 months
Assessment of tolerability by patient on a 4-point scaleafter 12 months
Number of patients with adverse drug reactionsup to 12 months
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