Last updated: 01/08/2021 09:40:08
Use of diagnostic measures in chronic obstructive pulmonary disease (COPD) in routine practice and their impact on treatment decisions
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Use of diagnostic measures (including blood eosinophil counts) and their impact on lung specialists’ treatment decisions in patients with COPD in Germany
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of physicians with usage of diagnostic tests in routine clinical practice
Timeframe: Up to 12 months
Number of physician reported rationale for choice of diagnostic test
Timeframe: Up to 12 months
Secondary outcomes:
Number of physician reported reasons for blood eosinophil test selection
Timeframe: Up to 12 months
Number of physician reported reasons for drug selection
Timeframe: Up to 12 months
Number of subjects with use of other diagnostic measures
Timeframe: Up to 12 months
Number of subjects with use of patient reported outcome (PRO) assessment
Timeframe: Up to 12 months
Number of subjects with a history of respiratory medication
Timeframe: Up to 12 months
Number of subjects receiving current medication
Timeframe: Up to 12 months
Number of subjects receiving COPD maintenance treatment
Timeframe: Up to 12 months
Number of subjects receiving immunosuppressive treatment
Timeframe: Up to 12 months
Number of subjects receiving allergic treatment
Timeframe: Up to 12 months
Number of subjects receiving oral corticosteroids (OCS) for exacerbations
Timeframe: Up to 12 months
Number of subjects with use of antibiotics
Timeframe: Up to 12 months
Number of subjects receiving any COPD medication
Timeframe: Up to 12 months
Number of subjects with history of exacerbations
Timeframe: Up to 12 months
Number of subjects with hospitalization for COPD
Timeframe: Up to 12 months
Number of subjects with emergency room visits related to COPD
Timeframe: Up to 12 months
Number of subjects with concomitant diseases
Timeframe: Up to 12 months
Interventions:
Other: Doctor's questionnaire
Other: Subject file
Enrollment:
251
Observational study model:
Cohort
Primary completion date:
2018-30-08
Time perspective:
Cross-Sectional
Clinical publications:
Not applicable
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
fluticasone furoate, fluticasone furoate/vilanterol/umeclidinium bromide, umeclidinium bromide, vilanterol
Collaborators
Institut Dr. Schauerte (IDS)
Study date(s)
April 2018 to August 2018
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
35+ years
Accepts healthy volunteers
Not applicable
- For participating centers (Sample 1: 30 lung specialists from Germany)
- More than 10 years of experience in respiratory medicine
- Subjects who are pregnant and breastfeeding (in the last 12 months)
- Subjects currently participating in any interventional study
Inclusion and exclusion 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
Trial location(s)
Location
GSK Investigational Site
Bruchsal, Baden-Wuerttemberg, Germany, 76646
Status
Study Complete
Location
GSK Investigational Site
Fuerstenwalde, Brandenburg, Germany, 15517
Status
Study Complete
Location
GSK Investigational Site
Garmisch-Partenirchen, Bayern, Germany, 82467
Status
Study Complete
Location
GSK Investigational Site
Guetersloh, Nordrhein-Westfalen, Germany, 33330
Status
Study Complete
Location
GSK Investigational Site
Halberstadt, Sachsen-Anhalt, Germany, 38820
Status
Study Complete
Location
GSK Investigational Site
Hettstedt, Sachsen-Anhalt, Germany, 06333
Status
Study Complete
Location
GSK Investigational Site
Koblenz, Rheinland-Pfalz, Germany, 56068
Status
Study Complete
Location
GSK Investigational Site
Lutherstadt Wittenberg, Sachsen-Anhalt, Germany, 06886
Status
Study Complete
Location
GSK Investigational Site
Menden, Nordrhein-Westfalen, Germany, 58706
Status
Study Complete
Location
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, Germany, 18107
Status
Study Complete
Location
GSK Investigational Site
Schleswig, Schleswig-Holstein, Germany, 24837
Status
Study Complete
Location
GSK Investigational Site
Ulm, Baden-Wuerttemberg, Germany, 89073
Status
Study Complete
Location
GSK Investigational Site
Warendorf, Nordrhein-Westfalen, Germany, 48231
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Protocol
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
2018-30-08
Actual study completion date
2018-30-08
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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