Postmarketing Surveillance Study to Assess Handling and Patient Satisfaction on Berodual® Respimat® Solution for Inhalation in Patients With Chronic Obstructive Pulmonary Disease

NCT02231320 | Completed

• 1 other identifier: 215.1367
• Study Type: observational
• Target: 236
• Locations: 0 countries
• Sites: N/A

Brief Summary

New perceptions about handling and patient satisfaction of the everyday use of Berodual® Respimat® in patients with chronic obstructive lung disease (COLD). Moreover, further knowledge should be attained about the tolerability of Berodual® Respimat®

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (2)

• Number of patients with adverse events

  up to 8 weeks

• Number of patients who premature discontinued therapy with Berodual® Respimat®

  up to 8 weeks

Secondary Outcomes (1)

• Assessment of patient satisfaction with regard to handling of Berodual® Respimat® inhaler

  up to 8 weeks

Study Arms (1)

Chronic Obstructive Pulmonary Disease patients

Drug: Berodual® Respimat® - inhaler

Interventions

Berodual® Respimat® - inhaler DRUG

Chronic Obstructive Pulmonary Disease patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with diagnosis of chronic obstructive pulmonary disease recruited at pneumologists in practice

You may qualify if:

• Male and female patients aged at least 18 years who were suffering from symptoms of a COLD (naive or pre-treated) could be included in the PMS

You may not qualify if:

• Patients who meet one or more of the general or specific contraindications mentioned in the Summary of Product Characteristics (SmPC) are excluded from the Postmarketing Surveillance (PMS)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2014
• First Posted: September 4, 2014
• Study Start: December 1, 2005
• Primary Completion: June 1, 2006
• Last Updated: September 4, 2014

Record last verified: 2014-09