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

January 11, 2019 updated by: GlaxoSmithKline

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
251

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10625
        • GSK Investigational Site
      • Berlin, Germany, 13057
        • GSK Investigational Site
    • Baden-Wuerttemberg
      • Bruchsal, Baden-Wuerttemberg, Germany, 76646
        • GSK Investigational Site
      • Ulm, Baden-Wuerttemberg, Germany, 89073
        • GSK Investigational Site
    • Bayern
      • Garmisch-Partenirchen, Bayern, Germany, 82467
        • GSK Investigational Site
      • Nuernberg, Bayern, Germany, 90489
        • GSK Investigational Site
    • Brandenburg
      • Beelitz, Brandenburg, Germany, 14547
        • GSK Investigational Site
      • Cottbus, Brandenburg, Germany, 03050
        • GSK Investigational Site
      • Fuerstenwalde, Brandenburg, Germany, 15517
        • GSK Investigational Site
      • Kyritz, Brandenburg, Germany, 16866
        • GSK Investigational Site
      • Potsdam, Brandenburg, Germany, 14467
        • GSK Investigational Site
    • Hessen
      • Frankfurt, Hessen, Germany, 60389
        • GSK Investigational Site
      • Wiesbaden, Hessen, Germany, 65183
        • GSK Investigational Site
    • Mecklenburg-Vorpommern
      • Rostock, Mecklenburg-Vorpommern, Germany, 18107
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Guetersloh, Nordrhein-Westfalen, Germany, 33330
        • GSK Investigational Site
      • Menden, Nordrhein-Westfalen, Germany, 58706
        • GSK Investigational Site
      • Warendorf, Nordrhein-Westfalen, Germany, 48231
        • GSK Investigational Site
    • Rheinland-Pfalz
      • Koblenz, Rheinland-Pfalz, Germany, 56068
        • GSK Investigational Site
    • Sachsen
      • Leipzig, Sachsen, Germany, 04357
        • GSK Investigational Site
      • Leipzig, Sachsen, Germany, 04103
        • GSK Investigational Site
      • Leipzig, Sachsen, Germany, 04157
        • GSK Investigational Site
    • Sachsen-Anhalt
      • Halberstadt, Sachsen-Anhalt, Germany, 38820
        • GSK Investigational Site
      • Halle, Sachsen-Anhalt, Germany, 06108
        • GSK Investigational Site
      • Hettstedt, Sachsen-Anhalt, Germany, 06333
        • GSK Investigational Site
      • Lutherstadt Wittenberg, Sachsen-Anhalt, Germany, 06886
        • GSK Investigational Site
    • Schleswig-Holstein
      • Schleswig, Schleswig-Holstein, Germany, 24837
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Lung specialist
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
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.
Subjects with COPD
Data from approximately 250 subjects with COPD under supervision of lung specialists enrolled in the study will be analyzed.
Other: Subject file
All subject-based data will be obtained by retrospective evaluation of subject files available at the treating lung specialist.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of physicians with usage of diagnostic tests in routine clinical practice
Time Frame: Up to 12 months
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
Number of physician reported rationale for choice of diagnostic test
Time Frame: Up to 12 months
The reasons for choice of diagnostic test will be determined from doctor's questionnaires and from medical chart review.
Up to 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of physician reported reasons for blood eosinophil test selection
Time Frame: Up to 12 months
The reasons blood eosinophil test selection will be analyzed using data from doctor's questionnaires.
Up to 12 months
Number of physician reported reasons for drug selection
Time Frame: Up to 12 months
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
Number of subjects with use of other diagnostic measures
Time Frame: Up to 12 months
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
Number of subjects with use of patient reported outcome (PRO) assessment
Time Frame: Up to 12 months
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
Number of subjects with a history of respiratory medication
Time Frame: Up to 12 months
Number of subjects with a history of respiratory medication will be analyzed using data from subject files.
Up to 12 months
Number of subjects receiving current medication
Time Frame: Up to 12 months
Number of subjects receiving current medication will be analyzed using data from subject files.
Up to 12 months
Number of subjects receiving COPD maintenance treatment
Time Frame: Up to 12 months
Number of subjects receiving COPD maintenance treatment will be analyzed using data from subject files.
Up to 12 months
Number of subjects receiving immunosuppressive treatment
Time Frame: Up to 12 months
Number of subjects receiving immunosuppressive treatment will be analyzed using data from subject files.
Up to 12 months
Number of subjects receiving allergic treatment
Time Frame: Up to 12 months
Number of subjects receiving allergic treatment will be analyzed using data from subject files.
Up to 12 months
Number of subjects receiving oral corticosteroids (OCS) for exacerbations
Time Frame: Up to 12 months
Number of subjects with maintenance and rescue use of OCS for exacerbations will be analyzed using data from subject files.
Up to 12 months
Number of subjects with use of antibiotics
Time Frame: Up to 12 months
Number of subjects with use of antibiotics will be analyzed using data from subject files.
Up to 12 months
Number of subjects receiving any COPD medication
Time Frame: Up to 12 months
Number of subjects receiving any COPD medication will be analyzed using data from subject files.
Up to 12 months
Number of subjects with history of exacerbations
Time Frame: Up to 12 months
Number of subjects with history of exacerbations will be analyzed using data from subject files.
Up to 12 months
Number of subjects with hospitalization for COPD
Time Frame: Up to 12 months
Number of subjects with hospitalization for COPD will be analyzed using data from subject files.
Up to 12 months
Number of subjects with emergency room visits related to COPD
Time Frame: Up to 12 months
Number of subjects with emergency room visits related to COPD will be analyzed using data from subject files.
Up to 12 months
Number of subjects with concomitant diseases
Time Frame: Up to 12 months
Number of subjects with concomitant diseases will be analyzed using data from subject files.
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GlaxoSmithKline

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Institut Dr. Schauerte (IDS)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 19, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 8, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 14, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 15, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 207733

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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