Pulmonary Disease, Chronic ObstructiveNCT03465332
Use of Diagnostic Measures in Chronic Obstructive Pulmonary Disease (COPD) in Routine Practice and Their Impact on Treatment Decisions
An observational study of Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 26 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Doctor's questionnaire and Subject file
- How many people
- 251 participants
- Where
- 26 sitesGermany
- Study dates
- 19 Apr 2018to 30 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
- 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 locations and contacts
26 sites in 1 country.
26 sites in 1 country
Germany26 sites
GSK Investigational Site
Beelitz, Brandenburg, 14547
GSK Investigational Site
Berlin, 10625
GSK Investigational Site
Berlin, 13057
GSK Investigational Site
Bruchsal, Baden-Wurttemberg, 76646
GSK Investigational Site
Cottbus, Brandenburg, 03050
GSK Investigational Site
Frankfurt am Main, Hesse, 60389
GSK Investigational Site
Fürstenwalde, Brandenburg, 15517
GSK Investigational Site
Garmisch-Partenirchen, Bavaria, 82467
GSK Investigational Site
Gütersloh, North Rhine-Westphalia, 33330
GSK Investigational Site
Halberstadt, Saxony-Anhalt, 38820
GSK Investigational Site
Halle, Saxony-Anhalt, 06108
GSK Investigational Site
Hettstedt, Saxony-Anhalt, 06333
GSK Investigational Site
Koblenz, Rhineland-Palatinate, 56068
GSK Investigational Site
Kyritz, Brandenburg, 16866
GSK Investigational Site
Leipzig, Saxony, 04103
GSK Investigational Site
Leipzig, Saxony, 04157
GSK Investigational Site
Leipzig, Saxony, 04357
GSK Investigational Site
Menden, North Rhine-Westphalia, 58706
GSK Investigational Site
Nuremberg, Bavaria, 90489
GSK Investigational Site
Potsdam, Brandenburg, 14467
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, 18107
GSK Investigational Site
Schleswig, Schleswig-Holstein, 24837
GSK Investigational Site
Ulm, Baden-Wurttemberg, 89073
GSK Investigational Site
Warendorf, North Rhine-Westphalia, 48231
GSK Investigational Site
Wiesbaden, Hesse, 65183
GSK Investigational Site
Wittenberg, Saxony-Anhalt, 06886
About this study
Official title: 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.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Doctor's questionnaire, Subject file
- Keywords
- blood eosinophil count, COPD, diagnostic test, doctor's questionnaire, Lung specialist
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doctor's questionnaireOther
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 fileOther
All subject-based data will be obtained by retrospective evaluation of subject files available at the treating lung specialist.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Doctor's questionnaire | |
| Subjects with COPD | Data from approximately 250 subjects with COPD under supervision of lung specialists enrolled in the study will be analyzed. Receives: Other: Subject file |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 12 months
Secondary outcomes (16)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 12 months
Number of subjects receiving current medication
Number of subjects receiving current medication will be analyzed using data from subject files.
Measured: 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.
Measured: Up to 12 months
Number of subjects receiving immunosuppressive treatment
Number of subjects receiving immunosuppressive treatment will be analyzed using data from subject files.
Measured: Up to 12 months
Number of subjects receiving allergic treatment
Number of subjects receiving allergic treatment will be analyzed using data from subject files.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 12 months
Number of subjects with concomitant diseases
Number of subjects with concomitant diseases will be analyzed using data from subject files.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start19 Apr 2018
- Primary completion30 Aug 2018
- Study completion30 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institut Dr. Schauerte (IDS)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKlineGSK Clinical Trials, Study director, GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03465332
- Sponsor's protocol ID
- 207733
- Status last verified
- Jan 2019
- First submitted
- 8 Mar 2018
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Diagnostic Measures (Including Blood Eosinophil Counts) and Their Impact on Lung Specialists' Treatment Decisions in Patients With COPD in Germany
- ClinicalTrials.gov ID
- NCT03465332
- Acronym / sponsor ID
- 207733
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- blood eosinophil count, COPD, diagnostic test, doctor's questionnaire, Lung specialist
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 251 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- Institut Dr. Schauerte (IDS)
- Study start
- 19 Apr 2018 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 14 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lung specialist | – | Other: Doctor's questionnaireApproximately 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. |
| Subjects with COPD | – | Other: Subject fileData from approximately 250 subjects with COPD under supervision of lung specialists enrolled in the study will be analyzed. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doctor's questionnaireThe survey of physicians will be performed using doctor's questionnaire, which will be developed by lung specialists who are not participating in the survey. | Other | Lung specialist |
| Subject fileAll subject-based data will be obtained by retrospective evaluation of subject files available at the treating lung specialist. | Other | Subjects with COPD |
Primary outcome
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.
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.
16 secondary outcomes
Number of physician reported reasons for blood eosinophil test selection
Time frame: Up to 12 months
Number of physician reported reasons for drug selection
Time frame: 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 patient reported outcome (PRO) assessment
Time frame: Up to 12 months
Number of subjects with a history of respiratory medication
Time frame: Up to 12 months
Number of subjects receiving current medication
Time frame: Up to 12 months
Number of subjects receiving COPD maintenance treatment
Time frame: Up to 12 months
Number of subjects receiving immunosuppressive treatment
Time frame: Up to 12 months
Number of subjects receiving allergic treatment
Time frame: Up to 12 months
Number of subjects receiving oral corticosteroids (OCS) for exacerbations
Time frame: Up to 12 months
Number of subjects with use of antibiotics
Time frame: Up to 12 months
Number of subjects receiving any COPD medication
Time frame: Up to 12 months
Number of subjects with history of exacerbations
Time frame: Up to 12 months
Number of subjects with hospitalization for COPD
Time frame: Up to 12 months
Number of subjects with emergency room visits related to COPD
Time frame: Up to 12 months
Number of subjects with concomitant diseases
Time frame: Up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
GSK Clinical Trials study director
GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 26 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of physicians with usage of diagnostic tests in routine clinical practice (time frame: Up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2019.