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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Other: Subject file; Other: Doctor's questionnaire

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT03465332

207733

Details and patient eligibility

About

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.

Enrollment: 251 patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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

Trial design

251 participants in 2 patient groups

Lung specialist

Description:

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.

Treatment:

Other: Doctor's questionnaire

Subjects with COPD

Description:

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

Treatment:

Other: Subject file