Postmarketing Surveillance Study of Anticholinergics - Prescribing Pattern and Therapeutic Long Term Value in Patients Suffering From Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD)

Postmarketing Surveillance Study (as Per §67(6 )AMG [German Drug Law]) of Anticholinergics - Prescribing Pattern and Therapeutic Long Term Value in Patients Suffering From Moderate or Severe Chronic Obstructive Pulmonary Disease

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02238184

Enrollment

105

Registered

2014-09-12

Start date

2001-01-31

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 prescribing pattern and therapeutic long term value in patients suffering from moderate or severs Chronic Obstructive Pulmonary Disease under conditions of daily practice

Interventions

DRUGAtrovent®

DRUGVentilat®

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients of both genders older than 40 years, who suffer from moderate or severe Chronic Obstructive Pulmonary Disease * Only patients who showed following diagnosis parameters were to be considered for inclusion * FEV1 (Forced expiratory volume in 1 second) and FEV1/VC (vital capacity) \<70% * Reversibility FEV1 \<12% in the last 6 months * Smoker or Ex-smoker (\>10 Pack years) * Asthma to be excluded

Exclusion criteria

• Contraindications listed in the Instructions for Use/Summary of Product Characteristics

Design outcomes

Primary

Measure	Time frame
Change in overall severity of the clinical picture rated on a 4-point scale	Up to 6 months after first study drug administration
Investigator assessment of improvement of thec linical picture rated on a 6-point symptom profile	Up to 6 months after first study drug administration

Secondary

Measure	Time frame
Assessment of tolerability by investigator on a 4-point scale	Up to 6 months after first study drug administration
Assessment of efficacy by investigator on a 4-point scale	Up to 6 months after first study drug administration
Number of patients with adverse drug reactions	Up to 6 months after first study drug administration
Assessment of tolerability by patient on a 4-point scale	Up to 6 months after first study drug administration
Assessment of efficacy by patient on a 4-point scale	Up to 6 months after first study drug administration

Outcome results

None listed

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