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

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: Ventilat®; Drug: Atrovent®

• Registration Number: NCT02238184
• Lead Sponsor: Boehringer Ingelheim

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

Detailed Description

Not available

Study Timeline

• Study Start: 2001-01
• Primary Completion: 2001-09
• Status Verified: 2014-09
• Study First Submitted: 2014-09-11
• Study First Submitted QC: 2014-09-11
• Last Update Submitted: 2014-09-11
• Study First Posted: 2014-09-12
• Last Update Posted: 2014-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cronic Obstructive Pulmonary Disease	Ventilat®	patients receiving Ventilat®
Chronic Obstructive Pulmonary Disease	Atrovent®	patients receiving Atrovent®

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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