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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02231320
Enrollment
236
Registered
2014-09-04
Start date
2005-12-31
Completion date
Unknown
Last updated
2014-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Disease, Chronic Obstructive

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®

Interventions

Sponsors

Boehringer Ingelheim
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
Number of patients with adverse eventsup to 8 weeks
Number of patients who premature discontinued therapy with Berodual® Respimat®up to 8 weeks

Secondary

MeasureTime frameDescription
Assessment of patient satisfaction with regard to handling of Berodual® Respimat® inhalerup to 8 weeksby means of patient satisfaction and preference questionnaire (PASAPQ)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026