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Post-marketing Surveillance of Ventilat® Metered Dose Inhaler in Chronic Obstructive Bronchitis

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02233920
Enrollment
716
Registered
2014-09-09
Start date
2000-01-31
Completion date
Unknown
Last updated
2014-09-09

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

Study to obtain further information on the tolerability and efficacy of Ventilat® metered-dose inhaler in the treatment of Chronic Obstructive bronchitis 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

* Primarily Patients of both genders older than 40 years, who suffer from Chronic Obstructive bronchitis * Only patients who have not been treated with an anticholinergic within the last year are to be considered for inclusion

Exclusion criteria

•Contraindications listed in the Instructions for Use/Summary of Product Characteristics for Ventilat® metered dose inhaler

Design outcomes

Primary

MeasureTime frame
Change in the clinical pictureafter 4 weeks

Secondary

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

Outcome results

None listed

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