Postmarketing Surveillance Study of Atrovent® Inhalation Solution in Chronic Obstructive Pulmonary Disease

N/ACompletedNCT02238197

Boehringer Ingelheim477 enrolled

Overview

To obtain further information on the tolerability and efficacy of Atrovent® 500µg/2ml inhalation solution in the treatment of Chronic Obstructive Pulmonary Disease under conditions of daily practice

Study Type

OBSERVATIONAL

Enrollment

477

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Atrovent® Inhalation SolutionDRUG

Eligibility

Sex: ALLMin age: 13 YearsMax age: 89 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients of both genders, older than 40 years,who suffer from chronic obstructive Pulmonary 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® 500µg/2ml Inhalation Solution * Patients who exhibited adverse drug reactions

Outcomes

Primary Outcomes

Change in total severity of the clinical picture rated on a 4-point scale

Time frame: Up to 4 weeks after first study drug administration

Investigator assessment of improvement of the clinical picture of the course on a 6-point symptoms profile

Time frame: up to 4 weeks after first study drug administration

Secondary Outcomes

Assessment of efficacy by investigator on a 4-point scale

Time frame: Up to 4 weeks after first study drug administration

Assessment of efficacy by patient on a 4-point scale

Time frame: Up to 4 weeks after first study drug administration

Assessment of tolerability by investigator on a 4-point scale

Time frame: Up to 4 weeks after first study drug administration

Assessment of tolerability by patient on a 4-point scale

Time frame: Up to 4 weeks after first study drug administration

Number of patients with adverse drug reactions

Time frame: Up to 4 weeks after first study drug administration

Data from ClinicalTrials.gov

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NCT02238197 - Postmarketing Surveillance Study of Atrovent® Inhalation Solution in Chronic Obstructive Pulmonary Disease | Crick | Crick