Berodual® Respimat® Solution for Inhalation in Patients With Chronic Obstructive Airways Disease

Boehringer Ingelheim2,006 enrolled

Overview

Tolerability, efficacy and handling of Berodual® Respimat® 20/50µg/dose solution for inhalation in patients with chronic obstructive airways disease in daily practice

Study Type

OBSERVATIONAL

Enrollment

2,006

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Berodual® Respimat® solution for inhalationDRUG

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Men and women presenting with the symptoms of chronic obstructive airways disease were given Berodual® Respimat® 20/50µg/dose solution for inhalation only where this was considered necessary in medical terms * Patients who have not been treated prior to the post-marketing surveillance study as well as patients who have been treated with Berodual® metered dose inhaler (MDI) or other respiratory medications prior to the Post-Marketing Surveillance Study could be included Exclusion Criteria: * Patients presenting with the general and specific contraindications listed in the Patient Information Leaflet and the Basic Product Information

Outcomes

Primary Outcomes

Change in overall severity of clinical picture rated on 3-point scale

Time frame: up to 12 weeks

Change in breathlessness rated on a 4-point scale

Time frame: up to 12 weeks

Change in restriction of activity due to breathlessness rated on a 4-point scale

Time frame: up to 12 weeks

Change in number of awakening due to nocturnal breathlessness rated on 4-point scale

Time frame: up to 12 weeks

Global assessment of efficacy by the patients rated on 5-point scale

Time frame: after 4, 8 and 12 weeks

Global assessment of efficacy by the investigator rated on 5-point scale

Time frame: after 4, 8 and 12 weeks

Number of patients with adverse drug reactions

Time frame: up to 12 weeks

Assessment of tolerability on a 5-point scale

Time frame: after 4, 8 and 12 weeks

Data from ClinicalTrials.gov

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