Clinical trial NCT03465332: Use of Diagnostic Measures in Chronic Obstructive Pulmonary Disease (COPD) in Routine Practice and Their Impact on Treatment Decisions
Official title: Use of Diagnostic Measures (Including Blood Eosinophil Counts) and Their Impact on Lung Specialists' Treatment Decisions in Patients With COPD in Germany
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: blood eosinophil count
COPD
diagnostic test
doctor's questionnaire
Lung specialist
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: Institut Dr. Schauerte (IDS)
First posted: 2018-03-14
Enrollment: 251
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of physicians with usage of diagnostic tests in routine clinical practice
timeFrame: Up to 12 months
measure: Number of physician reported rationale for choice of diagnostic test
timeFrame: Up to 12 months
Secondary outcomes:
measure: Number of physician reported reasons for blood eosinophil test selection
timeFrame: Up to 12 months
measure: Number of physician reported reasons for drug selection
timeFrame: Up to 12 months
measure: Number of subjects with use of other diagnostic measures
timeFrame: Up to 12 months
measure: Number of subjects with use of patient reported outcome (PRO) assessment
timeFrame: Up to 12 months
measure: Number of subjects with a history of respiratory medication
timeFrame: Up to 12 months
measure: Number of subjects receiving current medication
timeFrame: Up to 12 months
measure: Number of subjects receiving COPD maintenance treatment
timeFrame: Up to 12 months
measure: Number of subjects receiving immunosuppressive treatment
timeFrame: Up to 12 months
measure: Number of subjects receiving allergic treatment
timeFrame: Up to 12 months
measure: Number of subjects receiving oral corticosteroids (OCS) for exacerbations
timeFrame: Up to 12 months
measure: Number of subjects with use of antibiotics
timeFrame: Up to 12 months
measure: Number of subjects receiving any COPD medication
timeFrame: Up to 12 months
measure: Number of subjects with history of exacerbations
timeFrame: Up to 12 months
measure: Number of subjects with hospitalization for COPD
timeFrame: Up to 12 months
measure: Number of subjects with emergency room visits related to COPD
timeFrame: Up to 12 months
measure: Number of subjects with concomitant diseases
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Bruchsal
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Ulm
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Garmisch-Partenirchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Nuernberg
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Beelitz
country: Germany
facility: GSK Investigational Site
state: Brandenburg
city: Cottbus
country: Germany
facility: GSK Investigational Site
state: Brandenburg
city: Fuerstenwalde
country: Germany
facility: GSK Investigational Site
state: Brandenburg
city: Kyritz
country: Germany
facility: GSK Investigational Site
state: Brandenburg
city: Potsdam
country: Germany
facility: GSK Investigational Site
state: Brandenburg
city: Frankfurt
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Wiesbaden
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Rostock
country: Germany
facility: GSK Investigational Site
state: Mecklenburg-Vorpommern
city: Guetersloh
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Menden
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Warendorf
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Koblenz
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Halberstadt
country: Germany
facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Halle
country: Germany
facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Hettstedt
country: Germany
facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Lutherstadt Wittenberg
country: Germany
facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Schleswig
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
affiliation: GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: