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

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ClinicalTrials.gov Identifier: NCT03465332
Recruitment Status : Recruiting
First Posted : March 14, 2018
Last Update Posted : August 7, 2018
Sponsor:
Collaborator:
Institut Dr. Schauerte (IDS)
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
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.

Condition or disease Intervention/treatment
Pulmonary Disease, Chronic Obstructive Other: Doctor's questionnaire Other: Subject file

Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Use of Diagnostic Measures (Including Blood Eosinophil Counts) and Their Impact on Lung Specialists' Treatment Decisions in Patients With COPD in Germany
Actual Study Start Date : April 19, 2018
Estimated Primary Completion Date : September 30, 2018
Estimated Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD

Group/Cohort Intervention/treatment
Lung specialist
Approximately 30 lung specialists in Germany with a sufficient number of COPD subjects under supervision will be enrolled in the study to document physician's attitudes on COPD diagnosis and therapy, and to document data on about 250 subjects with COPD.
Other: Doctor's questionnaire
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.

Subjects with COPD
Data from approximately 250 subjects with COPD under supervision of lung specialists enrolled in the study will be analyzed.
Other: Subject file
All subject-based data will be obtained by retrospective evaluation of subject files available at the treating lung specialist.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Approximately 30 lung specialists (up to 50) in Germany with sufficient number of COPD subjects under supervision in a hospital or office based setting will be enrolled in the study. Data from the survey of lung specialists and retrospective medical data of 250 subjects with COPD under supervision of the 30 lung specialists (up to 50) enrolled in the study will be included in the analysis.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03465332


Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

Locations
Germany
GSK Investigational Site Completed
Bruchsal, Baden-Wuerttemberg, Germany, 76646
GSK Investigational Site Recruiting
Ulm, Baden-Wuerttemberg, Germany, 89073
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Garmisch-Partenirchen, Bayern, Germany, 82467
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Not yet recruiting
Nuernberg, Bayern, Germany, 90489
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Not yet recruiting
Beelitz, Brandenburg, Germany, 14547
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Cottbus, Brandenburg, Germany, 03050
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Completed
Fuerstenwalde, Brandenburg, Germany, 15517
GSK Investigational Site Recruiting
Kyritz, Brandenburg, Germany, 16866
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Potsdam, Brandenburg, Germany, 14467
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Frankfurt, Hessen, Germany, 60389
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Not yet recruiting
Wiesbaden, Hessen, Germany, 65183
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Completed
Rostock, Mecklenburg-Vorpommern, Germany, 18107
GSK Investigational Site Recruiting
Guetersloh, Nordrhein-Westfalen, Germany, 33330
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Menden, Nordrhein-Westfalen, Germany, 58706
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Warendorf, Nordrhein-Westfalen, Germany, 48231
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Koblenz, Rheinland-Pfalz, Germany, 56068
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Halberstadt, Sachsen-Anhalt, Germany, 38820
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Halle, Sachsen-Anhalt, Germany, 06108
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Hettstedt, Sachsen-Anhalt, Germany, 06333
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Lutherstadt Wittenberg, Sachsen-Anhalt, Germany, 06886
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Leipzig, Sachsen, Germany, 04103
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Leipzig, Sachsen, Germany, 04157
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Not yet recruiting
Leipzig, Sachsen, Germany, 04357
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Completed
Schleswig, Schleswig-Holstein, Germany, 24837
GSK Investigational Site Recruiting
Schleswig, Schleswig-Holstein, Germany, 24837
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Berlin, Germany, 10625
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Berlin, Germany, 13057
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Sponsors and Collaborators
GlaxoSmithKline
Institut Dr. Schauerte (IDS)
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03465332     History of Changes
Other Study ID Numbers: 207733
First Posted: March 14, 2018    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by GlaxoSmithKline:
blood eosinophil count
COPD
diagnostic test
doctor's questionnaire
Lung specialist

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes