An observational study in Pulmonary Disease, Chronic Obstructive, sponsored by GlaxoSmithKline. Completed at 26 sites in Germany. Open to participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2019-01-15.
Sponsored by GlaxoSmithKline · Observational
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.
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.
For participating centers (Sample 1: 30 lung specialists from Germany)
For subjects (Sample 2: 250 COPD subjects from these 30 doctors from sample 1)
Exclusion Criteria:
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
Data from approximately 250 subjects with COPD under supervision of lung specialists enrolled in the study will be analyzed.
Other: Subject file
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.
All subject-based data will be obtained by retrospective evaluation of subject files available at the treating lung specialist.
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
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
Plan to share: No
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This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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GlaxoSmithKline