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Postmarketing Surveillance Study of Atrovent® Inhalation Solution in Chronic Obstructive Pulmonary Disease

Postmarketing Surveillance Study (as Per §67 (6) AMG [German Drug Law]) of Atrovent® 500µg/2ml Inhalation Solution in Chronic Obstructive Pulmonary Disease

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02238197
Enrollment
477
Registered
2014-09-12
Start date
2001-02-28
Completion date
Unknown
Last updated
2014-09-12

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

To obtain further information on the tolerability and efficacy of Atrovent® 500µg/2ml inhalation solution in the treatment of Chronic Obstructive Pulmonary Disease under conditions of daily practice

Interventions

DRUGAtrovent® Inhalation Solution

Sponsors

Boehringer Ingelheim
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
13 Years to 89 Years
Healthy volunteers
No

Inclusion criteria

* Patients of both genders, older than 40 years,who suffer from chronic obstructive Pulmonary 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® 500µg/2ml Inhalation Solution * Patients who exhibited adverse drug reactions

Design outcomes

Primary

MeasureTime frame
Investigator assessment of improvement of the clinical picture of the course on a 6-point symptoms profileup to 4 weeks after first study drug administration
Change in total severity of the clinical picture rated on a 4-point scaleUp to 4 weeks after first study drug administration

Secondary

MeasureTime frame
Assessment of tolerability by investigator on a 4-point scaleUp to 4 weeks after first study drug administration
Assessment of efficacy by investigator on a 4-point scaleUp to 4 weeks after first study drug administration
Number of patients with adverse drug reactionsUp to 4 weeks after first study drug administration
Assessment of tolerability by patient on a 4-point scaleUp to 4 weeks after first study drug administration
Assessment of efficacy by patient on a 4-point scaleUp to 4 weeks after first study drug administration

Outcome results

None listed

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