Skip to main content
OpenTrials
Completed

NCT Number: NCT03465332

Use of Diagnostic Measures in Chronic Obstructive Pulmonary Disease (COPD) in Routine Practice and Their Impact on Treatment Decisions

This study will evaluate the diagnostic measures (including blood eosinophil counts) commonly used by lung specialist's in routine clinical care of subjects with COPD in Germany and how these diagnostic tests influence the physician's treatment decisions. The study will be conducted in three parts. In the first part, lung specialist's, who will not participate in the survey, will develop doctor's questionnaire. The second part is an interventional cross-sectional study, wherein approximately 30 lung specialists will be enrolled and data on their perspective on diagnosis and treatment of COPD subjects will be collected via the revised doctor's questionnaire. The third part is a retrospective non-interventional study where each doctor will collect retrospective data from selected subjects with COPD from the time of informed consent up to 12 months before. The retrospective data will be collected from subject files of approximately 250 subjects with COPD.

Completed

Looking for future studies?

Notify Me

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

35 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site, Bruchsal, Baden-Wurttemberg, Germany

Loading trial locations.

Who can participate

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

Inclusion criteria

For participating centers (Sample 1: 30 lung specialists from Germany)

  • More than 10 years of experience in respiratory medicine
  • At least 500 subjects under supervision in hospital- or office-based setting: a) Focus on obstructive lung diseases. b) Board certification. c) Informed consent to participate in this study and to share files of consenting subjects.

For subjects (Sample 2: 250 COPD subjects from these 30 doctors from sample 1)

  • Written informed consent to use his/her data.
  • Age >=40 years
  • Pack years >10, current or former smoking
  • Duration of COPD: >=1 year since COPD diagnosis record in subject files (also confirmed by spirometry)
  • No concurrent asthma diagnosis
  • At least one year of documented disease history at participating study doctors and have to be under the care of the before mentioned physician during this time because of COPD.

Exclusion criteria

  • Subjects who are pregnant and breastfeeding (in the last 12 months)
  • Subjects currently participating in any interventional study
  • Subjects with severe comorbidities which would have influence on the COPD therapy

Treatment and study plan

Doctor's questionnaire

Other

The survey of physicians will be performed using doctor's questionnaire, which will be developed by lung specialists who are not participating in the survey.

Subject file

Other

All subject-based data will be obtained by retrospective evaluation of subject files available at the treating lung specialist.

Primary outcomes

  1. Number of physicians with usage of diagnostic tests in routine clinical practice

    Time frame: Up to 12 months

    The data on diagnostic test including blood eosinophil count commonly used by lung specialists in routine clinical practice will be obtained from doctor's questionnaire.

  2. Number of physician reported rationale for choice of diagnostic test

    Time frame: Up to 12 months

    The reasons for choice of diagnostic test will be determined from doctor's questionnaires and from medical chart review.

Secondary outcomes

  1. Number of physician reported reasons for blood eosinophil test selection

    Time frame: Up to 12 months

    The reasons blood eosinophil test selection will be analyzed using data from doctor's questionnaires.

  2. Number of physician reported reasons for drug selection

    Time frame: Up to 12 months

    The selection of drugs by lung specialists for subjects with COPD will be analyzed using information obtained from medical chart review.

  3. Number of subjects with use of other diagnostic measures

    Time frame: Up to 12 months

    Number of subjects with use of other diagnostic measures such as spirometry, X-ray, thoracic computer tomography and specific blood tests will be analyzed using data from subject files.

  4. Number of subjects with use of patient reported outcome (PRO) assessment

    Time frame: Up to 12 months

    Number of subjects with use of questionnaires like COPD assessment test (CAT) and dyspnea assessment will be analyzed using data from subject files.

  5. Number of subjects with a history of respiratory medication

    Time frame: Up to 12 months

    Number of subjects with a history of respiratory medication will be analyzed using data from subject files.

  6. Number of subjects receiving current medication

    Time frame: Up to 12 months

    Number of subjects receiving current medication will be analyzed using data from subject files.

  7. Number of subjects receiving COPD maintenance treatment

    Time frame: Up to 12 months

    Number of subjects receiving COPD maintenance treatment will be analyzed using data from subject files.

  8. Number of subjects receiving immunosuppressive treatment

    Time frame: Up to 12 months

    Number of subjects receiving immunosuppressive treatment will be analyzed using data from subject files.

  9. Number of subjects receiving allergic treatment

    Time frame: Up to 12 months

    Number of subjects receiving allergic treatment will be analyzed using data from subject files.

  10. Number of subjects receiving oral corticosteroids (OCS) for exacerbations

    Time frame: Up to 12 months

    Number of subjects with maintenance and rescue use of OCS for exacerbations will be analyzed using data from subject files.

  11. Number of subjects with use of antibiotics

    Time frame: Up to 12 months

    Number of subjects with use of antibiotics will be analyzed using data from subject files.

  12. Number of subjects receiving any COPD medication

    Time frame: Up to 12 months

    Number of subjects receiving any COPD medication will be analyzed using data from subject files.

  13. Number of subjects with history of exacerbations

    Time frame: Up to 12 months

    Number of subjects with history of exacerbations will be analyzed using data from subject files.

  14. Number of subjects with hospitalization for COPD

    Time frame: Up to 12 months

    Number of subjects with hospitalization for COPD will be analyzed using data from subject files.

  15. Number of subjects with emergency room visits related to COPD

    Time frame: Up to 12 months

    Number of subjects with emergency room visits related to COPD will be analyzed using data from subject files.

  16. Number of subjects with concomitant diseases

    Time frame: Up to 12 months

    Number of subjects with concomitant diseases will be analyzed using data from subject files.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Collaborators

  • Institut Dr. Schauerte (IDS)

Registry information

Official study title

Use of Diagnostic Measures (Including Blood Eosinophil Counts) and Their Impact on Lung Specialists' Treatment Decisions in Patients With COPD in Germany

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 14, 2018
Registry last updated
Jan 15, 2019

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.