Postmarketing Surveillance Study of Atrovent® in Chronic Obstructive Airways Disease

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

Postmarketing Surveillance Study (as Per §67(6)AMG[German Drug Law]) of Atrovent® Unit Dose Vial 500 µg in Chronic Obstructive Airways Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02236715
• Other study ID #: 244.2493
• Status: Completed
• Phase: N/A
• First received: September 10, 2014
• Last updated: September 10, 2014
• Start date: September 1999

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 Atrovent® unit dose vial 500 µg in the treatment of Chronic Obstructive Airways Disease under conditions of daily practice

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1039
• Est. primary completion date: February 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

• Primarily patients of both gender, older than 30 years, who suffer from chronic obstructive airways disease

• Only patients who had not been treated with Atrovent® within the last year were to be considered for inclusion

Exclusion Criteria:

• Contraindication listed in the instructions for use/summary of product characteristics for Atrovent® unit dose vial 500 µg

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Atrovent®

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 total severity of the clinical picture rated on a 4-point scale		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	Assessment of tolerability by investigator on a 4-point scale		after 4 weeks	No
Secondary	Assessment of tolerability by patient on a 4-point scale		after 4 weeks	No
Secondary	Number of patients with adverse drug reactions		up to 4 weeks	No

External Links

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