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

GlaxoSmithKline251 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

251

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Doctor's questionnaireOTHER

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 fileOTHER

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

Eligibility

Sex: ALLMin age: 35 Years

Medical Language ↔ Plain English

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

Locations (26)

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

...and 16 more locations

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Up to 12 months

Secondary Outcomes

Number of physician reported reasons for blood eosinophil test selection

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

Time frame: Up to 12 months

Number of physician reported reasons for drug selection

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

Time frame: Up to 12 months

Number of subjects with use of other diagnostic measures

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.

Time frame: Up to 12 months

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

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

Time frame: Up to 12 months

Number of subjects with a history of respiratory medication

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

Time frame: Up to 12 months

Number of subjects receiving current medication

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

Time frame: Up to 12 months

Number of subjects receiving COPD maintenance treatment

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

Time frame: Up to 12 months

Number of subjects receiving immunosuppressive treatment

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

Time frame: Up to 12 months

Number of subjects receiving allergic treatment

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

Time frame: Up to 12 months

Number of subjects receiving oral corticosteroids (OCS) for exacerbations

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

Time frame: Up to 12 months

Number of subjects with use of antibiotics

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

Time frame: Up to 12 months

Number of subjects receiving any COPD medication

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

Time frame: Up to 12 months

Number of subjects with history of exacerbations

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

Time frame: Up to 12 months

Number of subjects with hospitalization for COPD

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

Time frame: Up to 12 months

Number of subjects with emergency room visits related to COPD

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

Time frame: Up to 12 months

Number of subjects with concomitant diseases

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

Time frame: Up to 12 months

Data from ClinicalTrials.gov

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