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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02238184
• Other study ID #: 244.2499
• Status: Completed
• Phase: N/A
• First received: September 11, 2014
• Last updated: September 11, 2014
• Start date: January 2001

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. primary completion date: September 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Intervention

Drug:
• Atrovent®

• Ventilat®

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 overall severity of the clinical picture rated on a 4-point scale		Up to 6 months after first study drug administration	No
Primary	Investigator assessment of improvement of thec linical picture rated on a 6-point symptom profile		Up to 6 months after first study drug administration	No
Secondary	Assessment of efficacy by investigator on a 4-point scale		Up to 6 months after first study drug administration	No
Secondary	Assessment of efficacy by patient on a 4-point scale		Up to 6 months after first study drug administration	No
Secondary	Assessment of tolerability by investigator on a 4-point scale		Up to 6 months after first study drug administration	No
Secondary	Assessment of tolerability by patient on a 4-point scale		Up to 6 months after first study drug administration	No
Secondary	Number of patients with adverse drug reactions		Up to 6 months after first study drug administration	No

External Links

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