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

NCT03465332 | Completed

• 1 other identifier: 207733
• Study Type: observational
• Target: 251
• Locations: 1 country
• Sites: 26

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

Keywords

blood eosinophil count; COPD; diagnostic test; doctor's questionnaire; Lung specialist

Outcome Measures

Primary Outcomes (2)

• Number of physicians with usage of diagnostic tests in routine clinical practice

  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.

  Up to 12 months

• Number of physician reported rationale for choice of diagnostic test

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

  Up to 12 months

Secondary Outcomes (16)

• Number of physician reported reasons for blood eosinophil test selection

  Up to 12 months

• Number of physician reported reasons for drug selection

  Up to 12 months

• Number of subjects with use of other diagnostic measures

  Up to 12 months

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

  Up to 12 months

• Number of subjects with a history of respiratory medication

  Up to 12 months

Study Arms (2)

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

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

Interventions

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.

Lung specialist

Subject file OTHER

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

Subjects with COPD

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead
• Institut Dr. Schauerte (IDS): collaborator

Study Sites (26)

GSK Investigational Site

Bruchsal, Baden-Wurttemberg, 76646, Germany

Location

GSK Investigational Site

Ulm, Baden-Wurttemberg, 89073, Germany

Location

GSK Investigational Site

Garmisch-Partenirchen, Bavaria, 82467, Germany

Location

GSK Investigational Site

Nuremberg, Bavaria, 90489, Germany

Location

GSK Investigational Site

Beelitz, Brandenburg, 14547, Germany

Location

GSK Investigational Site

Cottbus, Brandenburg, 03050, Germany

Location

GSK Investigational Site

Fürstenwalde, Brandenburg, 15517, Germany

Location

GSK Investigational Site

Kyritz, Brandenburg, 16866, Germany

Location

GSK Investigational Site

Potsdam, Brandenburg, 14467, Germany

Location

GSK Investigational Site

Frankfurt am Main, Hesse, 60389, Germany

Location

GSK Investigational Site

Wiesbaden, Hesse, 65183, Germany

Location

GSK Investigational Site

Rostock, Mecklenburg-Vorpommern, 18107, Germany

Location

GSK Investigational Site

Gütersloh, North Rhine-Westphalia, 33330, Germany

Location

GSK Investigational Site

Menden, North Rhine-Westphalia, 58706, Germany

Location

GSK Investigational Site

Warendorf, North Rhine-Westphalia, 48231, Germany

Location

GSK Investigational Site

Koblenz, Rhineland-Palatinate, 56068, Germany

Location

GSK Investigational Site

Leipzig, Saxony, 04103, Germany

Location

GSK Investigational Site

Leipzig, Saxony, 04157, Germany

Location

GSK Investigational Site

Leipzig, Saxony, 04357, Germany

Location

GSK Investigational Site

Halberstadt, Saxony-Anhalt, 38820, Germany

Location

GSK Investigational Site

Halle, Saxony-Anhalt, 06108, Germany

Location

GSK Investigational Site

Hettstedt, Saxony-Anhalt, 06333, Germany

Location

GSK Investigational Site

Wittenberg, Saxony-Anhalt, 06886, Germany

Location

GSK Investigational Site

Schleswig, Schleswig-Holstein, 24837, Germany

Location

GSK Investigational Site

Berlin, 10625, Germany

Location

GSK Investigational Site

Berlin, 13057, Germany

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

• GSK Clinical Trials

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

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: March 8, 2018
• First Posted: March 14, 2018
• Study Start: April 19, 2018
• Primary Completion: August 30, 2018
• Study Completion: August 30, 2018
• Last Updated: January 15, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (26)