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NCT02231320 Clinical Trial

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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:
Berodual® Respimat® 20/50 Microgram/Dose Solution for Inhalation: Assessment of Handling and Patient Satisfaction

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02231320
Other study ID # 215.1367
Secondary ID
Status Completed
Phase N/A
First received September 2, 2014
Last updated September 2, 2014
Start date December 2005

Study information
Verified date September 2014
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Observational

Clinical Trial 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®

Recruitment information / eligibility
Status Completed
Enrollment 236
Est. completion date
Est. primary completion date June 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Berodual® Respimat® - inhaler

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Boehringer Ingelheim

Outcome
Type Measure Description Time frame Safety issue
Primary Number of patients with adverse events up to 8 weeks No
Primary Number of patients who premature discontinued therapy with Berodual® Respimat® up to 8 weeks No
Secondary Assessment of patient satisfaction with regard to handling of Berodual® Respimat® inhaler by means of patient satisfaction and preference questionnaire (PASAPQ) up to 8 weeks No
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