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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

Use of Diagnostic Measures (Including Blood Eosinophil Counts) and Their Impact on Lung Specialists' Treatment Decisions in Patients With COPD in Germany

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03465332
• Other study ID #: 207733
• Status: Completed
• Start date: April 19, 2018
• Est. completion date: August 30, 2018

Study information

• Verified date: January 2019
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 251
• Est. completion date: August 30, 2018
• Est. primary completion date: August 30, 2018
• Gender: All
• Age group: 35 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Locations

Country	Name	City	State
Germany	GSK Investigational Site	Beelitz	Brandenburg
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Bruchsal	Baden-Wuerttemberg
Germany	GSK Investigational Site	Cottbus	Brandenburg
Germany	GSK Investigational Site	Frankfurt	Hessen
Germany	GSK Investigational Site	Fuerstenwalde	Brandenburg
Germany	GSK Investigational Site	Garmisch-Partenirchen	Bayern
Germany	GSK Investigational Site	Guetersloh	Nordrhein-Westfalen
Germany	GSK Investigational Site	Halberstadt	Sachsen-Anhalt
Germany	GSK Investigational Site	Halle	Sachsen-Anhalt
Germany	GSK Investigational Site	Hettstedt	Sachsen-Anhalt
Germany	GSK Investigational Site	Koblenz	Rheinland-Pfalz
Germany	GSK Investigational Site	Kyritz	Brandenburg
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Lutherstadt Wittenberg	Sachsen-Anhalt
Germany	GSK Investigational Site	Menden	Nordrhein-Westfalen
Germany	GSK Investigational Site	Nuernberg	Bayern
Germany	GSK Investigational Site	Potsdam	Brandenburg
Germany	GSK Investigational Site	Rostock	Mecklenburg-Vorpommern
Germany	GSK Investigational Site	Schleswig	Schleswig-Holstein
Germany	GSK Investigational Site	Ulm	Baden-Wuerttemberg
Germany	GSK Investigational Site	Warendorf	Nordrhein-Westfalen
Germany	GSK Investigational Site	Wiesbaden	Hessen

Sponsors (2)

Lead Sponsor	Collaborator
GlaxoSmithKline	Institut Dr. Schauerte (IDS)

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	Up to 12 months
Secondary	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.	Up to 12 months
Secondary	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.	Up to 12 months
Secondary	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.	Up to 12 months
Secondary	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.	Up to 12 months
Secondary	Number of subjects receiving current medication	Number of subjects receiving current medication will be analyzed using data from subject files.	Up to 12 months
Secondary	Number of subjects receiving COPD maintenance treatment	Number of subjects receiving COPD maintenance treatment will be analyzed using data from subject files.	Up to 12 months
Secondary	Number of subjects receiving immunosuppressive treatment	Number of subjects receiving immunosuppressive treatment will be analyzed using data from subject files.	Up to 12 months
Secondary	Number of subjects receiving allergic treatment	Number of subjects receiving allergic treatment will be analyzed using data from subject files.	Up to 12 months
Secondary	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.	Up to 12 months
Secondary	Number of subjects with use of antibiotics	Number of subjects with use of antibiotics will be analyzed using data from subject files.	Up to 12 months
Secondary	Number of subjects receiving any COPD medication	Number of subjects receiving any COPD medication will be analyzed using data from subject files.	Up to 12 months
Secondary	Number of subjects with history of exacerbations	Number of subjects with history of exacerbations will be analyzed using data from subject files.	Up to 12 months
Secondary	Number of subjects with hospitalization for COPD	Number of subjects with hospitalization for COPD will be analyzed using data from subject files.	Up to 12 months
Secondary	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.	Up to 12 months
Secondary	Number of subjects with concomitant diseases	Number of subjects with concomitant diseases will be analyzed using data from subject files.	Up to 12 months