Skip to content

Postmarketing Surveillance Study of Berodual® Metered-dose Inhaler in Chronic Obstructive Respiratory Tract Disease

Postmarketing Surveillance Study (as Per § 67 (6) AMG [German Drug Law]) of Berodual® Metered-dose Inhaler in Chronic Obstructive Respiratory Tract Disease

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02232594
Enrollment
834
Registered
2014-09-05
Start date
2000-01-31
Completion date
Unknown
Last updated
2014-09-05

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

The aim of this postmarketing surveillance is to obtain further information about the tolerability and efficacy of Berodual® metered-dose inhaler in the treatment of chronic obstructive respiratory tract disease under conditions of daily practice

Interventions

Sponsors

Boehringer Ingelheim
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

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

Inclusion criteria

* Patients of either sex over 40 years with the symptoms of a chronic obstructive airways disease * Only patients which have not been treated with Berodual® within the last year should be included

Exclusion criteria

* Contraindications listed in the Instructions for Use/Summary of Product Characteristics for Berodual® metered-dose inhaler

Design outcomes

Primary

MeasureTime frame
Overall severity of the clinical picture rated on a 4- point scaleafter 3 and 6 weeks

Secondary

MeasureTime frame
Assessment of tolerability by investigator on a 4-point scaleafter 3 and 6 weeks
Assessment of tolerability by patient on a 4-point scaleafter 3 and 6 weeks
Assessment of efficacy by investigator on a 4-point scaleafter 3 and 6 weeks
Assessment of efficacy by patient on a 4-point scaleafter 3 and 6 weeks
Number of patients with adverse drug reactionsup to 6 weeks

Outcome results

None listed

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