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

Berodual® Respimat® 20/50 Microgram/Dose Solution for Inhalation: Assessment of Handling and Patient Satisfaction in Comparison to a Powder Inhaler

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02231346
Enrollment
150
Registered
2014-09-04
Start date
2005-10-31
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® compared to a powder inhaler 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 * Patients who are suffering from symptoms of a chronic obstructive lung disease (COLD) can be included in the PMS. To reduce influences caused by the use of a variety of different powder inhaler, only patients who are already regularly using Diskus® powder inhaler should be included, as the Diskus® as well as the Berodual® Respimat® are multiple dose devices * During the PMS the Diskus® therapy is to be continued

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 4 weeks
Number of patients who prematurely discontinued therapy with Berodual® Respimat®up to 4 weeks

Secondary

MeasureTime frameDescription
Assessment of patient satisfaction with regard to handling of Berodual® Respimat® inhalerup to 4 weeksby means of a patient satisfaction and preference questionnaire (PASAPQ)
Assessment of patient satisfaction with regard to handling of Diskus® inhalerBaselineby means of patient satisfaction and preference questionnaire (PASAPQ)

Outcome results

None listed

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