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

NCT02238184 | Completed

• 1 other identifier: 244.2499
• Study Type: observational
• Target: 105
• Locations: 0 countries
• Sites: N/A

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

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Assessment of efficacy by investigator 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 tolerability by patient 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

Study Arms (2)

Chronic Obstructive Pulmonary Disease

patients receiving Atrovent®

Drug: Atrovent®

Cronic Obstructive Pulmonary Disease

patients receiving Ventilat®

Drug: Ventilat®

Interventions

Atrovent® DRUG

Chronic Obstructive Pulmonary Disease

Ventilat® DRUG

Cronic Obstructive Pulmonary Disease

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic obstructive airways disease recruited by registered pneumologists

You may qualify if:

• Patients of both genders older than 40 years, who suffer from moderate or severe Chronic Obstructive Pulmonary Disease
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Ipratropium; oxitropium

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2014
• First Posted: September 12, 2014
• Study Start: January 1, 2001
• Primary Completion: September 1, 2001
• Last Updated: September 12, 2014

Record last verified: 2014-09