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OpenTrials
Completed

NCT Number: NCT02238184

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

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

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Key information

Conditions

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

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atrovent®

Drug

Ventilat®

Drug

Primary outcomes

  1. Change in overall severity of the clinical picture rated on a 4-point scale

    Time frame: Up to 6 months after first study drug administration

  2. Investigator assessment of improvement of thec linical picture rated on a 6-point symptom profile

    Time frame: Up to 6 months after first study drug administration

Secondary outcomes

  1. Assessment of efficacy by investigator on a 4-point scale

    Time frame: Up to 6 months after first study drug administration

  2. Assessment of efficacy by patient on a 4-point scale

    Time frame: Up to 6 months after first study drug administration

  3. Assessment of tolerability by investigator on a 4-point scale

    Time frame: Up to 6 months after first study drug administration

  4. Assessment of tolerability by patient on a 4-point scale

    Time frame: Up to 6 months after first study drug administration

  5. Number of patients with adverse drug reactions

    Time frame: Up to 6 months after first study drug administration

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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

Important dates

Study start
2001
Primary completion
2001
First posted
Sep 12, 2014
Registry last updated
Sep 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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