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

NCT ID: NCT03465332

Last Updated: 2019-01-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 251 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-04-19
• Study Completion Date: 2018-08-30

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

Doctor's questionnaire

Intervention Type: 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.

Subjects with COPD

Data from approximately 250 subjects with COPD under supervision of lung specialists enrolled in the study will be analyzed.

Subject file

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Subject file

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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Dr. Schauerte (IDS)

UNKNOWN

Sponsor Role: collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)

Locations

GSK Investigational Site

Bruchsal, Baden-Wurttemberg, Germany

GSK Investigational Site

Ulm, Baden-Wurttemberg, Germany

GSK Investigational Site

Garmisch-Partenirchen, Bavaria, Germany

GSK Investigational Site

Nuremberg, Bavaria, Germany

GSK Investigational Site

Beelitz, Brandenburg, Germany

GSK Investigational Site

Cottbus, Brandenburg, Germany

GSK Investigational Site

Fürstenwalde, Brandenburg, Germany

GSK Investigational Site

Kyritz, Brandenburg, Germany

GSK Investigational Site

Potsdam, Brandenburg, Germany

GSK Investigational Site

Frankfurt am Main, Hesse, Germany

GSK Investigational Site

Wiesbaden, Hesse, Germany

GSK Investigational Site

Rostock, Mecklenburg-Vorpommern, Germany

GSK Investigational Site

Gütersloh, North Rhine-Westphalia, Germany

GSK Investigational Site

Menden, North Rhine-Westphalia, Germany

GSK Investigational Site

Warendorf, North Rhine-Westphalia, Germany

GSK Investigational Site

Koblenz, Rhineland-Palatinate, Germany

GSK Investigational Site

Leipzig, Saxony, Germany

GSK Investigational Site

Leipzig, Saxony, Germany

GSK Investigational Site

Leipzig, Saxony, Germany

GSK Investigational Site

Halberstadt, Saxony-Anhalt, Germany

GSK Investigational Site

Halle, Saxony-Anhalt, Germany

GSK Investigational Site

Hettstedt, Saxony-Anhalt, Germany

GSK Investigational Site

Wittenberg, Saxony-Anhalt, Germany

GSK Investigational Site

Schleswig, Schleswig-Holstein, Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Berlin, , Germany

Countries

Germany

Other Identifiers

207733

Identifier Type: -

Identifier Source: org_study_id