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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02233920
• Other study ID #: 54.564
• Status: Completed
• Phase: N/A
• First received: September 8, 2014
• Last updated: September 8, 2014
• Start date: January 2000

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 716
• Est. primary completion date: December 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bronchitis
• Bronchitis, Chronic
• Chronic Disease
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Ventilat® - metered dose inhaler

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the clinical picture		after 4 weeks	No
Secondary	Assessment of efficacy by investigator on a 4-point scale		after 4 weeks	No
Secondary	Assessment of efficacy by patient on a 4-point scale		after 4 weeks	No
Secondary	Number of patients with adverse drug reactions		up to 4 weeks	No
Secondary	Assessment of tolerability by investigator on a 4-point scale		after 4 weeks	No
Secondary	Assessment of patient by investigator on a 4-point scale		after 4 weeks	Yes

External Links

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