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Postmarketing Surveillance Study of Atrovent® in Chronic Obstructive Airways Disease

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02236715
Enrollment
1039
Registered
2014-09-11
Start date
1999-09-30
Completion date
Unknown
Last updated
2014-09-11

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 Atrovent® unit dose vial 500 µg in the treatment of Chronic Obstructive Airways 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
30 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change in total severity of the clinical picture rated on a 4-point scaleafter 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
Assessment of tolerability by investigator on a 4-point scaleafter 4 weeks
Assessment of tolerability by patient on a 4-point scaleafter 4 weeks
Number of patients with adverse drug reactionsup to 4 weeks

Outcome results

None listed

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