An observational study in Pulmonary Disease, Chronic Obstructive, sponsored by GlaxoSmithKline. Completed at 26 sites in Germany. Open to participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2019-01-15.
Sponsored by GlaxoSmithKline · Observational
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 276 studies in Pulmonary Disease, Chronic Obstructive by GlaxoSmithKline — 7 open to participants now, 8 under way, 5 of them phase 3. Pulmonary Disease, Chronic Obstructive · GlaxoSmithKline.
Among the 276 studies in Pulmonary Disease, Chronic Obstructive by GlaxoSmithKline, this one is the 33rd largest by enrollment of the 40 observational ones that give a count, is one of 12 that started in 2018, is one of 40 observational ones, and was the 249th registered.
5,522 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 857 are open to participants now.
Browse Pulmonary Disease, Chronic Obstructive studies →7 of the 276 studies in Pulmonary Disease, Chronic Obstructive by GlaxoSmithKline are open now, in 12 countries. Recruiting first, the newest first:
GlaxoSmithKline · Sites in United States, Argentina
Ages 40–80
GlaxoSmithKline · Sites in United States, Japan
Ages 40–80
GlaxoSmithKline · Sites in United Kingdom
Ages 18–55 · Healthy volunteers
GlaxoSmithKline · Sites in United States, Australia, Bulgaria and 10 more countries
Ages 40–75
GlaxoSmithKline · Sites in United States, Argentina, Australia and 13 more countries
Ages 40–80
By country, each count listing its studies:
Of the 557 Pulmonary Disease, Chronic Obstructive studies recruiting now, 306 (55%) set no upper age limit and 82 (15%) stop at 75 or younger; 29 take children under 18; 89 take healthy volunteers.
This study: 35 Years and older · all sexes.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
276 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 84 · Phase 2 47 · Phase 3 65 · Phase 4 38
First in 2000; this study’s year is marked. 12 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 251 is above the median of 159 across 1,498 observational studies indexed under Pulmonary Disease, Chronic Obstructive.
Median enrollment 101 across the 236 interventional studies, 1,248 across the 40 observational. Of the 264 that completed or were terminated, 141 (53%) have results posted.
This tab as a report to print or save as PDF → With an account.
GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 117 are open to participants now.
Of its 265 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
2 of the studies in Pulmonary Disease, Chronic Obstructive by GlaxoSmithKline that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06154837GlaxoSmithKlineA Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease | 2026-12-16 |
| NCT07789899GlaxoSmithKlineA Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Two GSK3862995B Formulations in Healthy Participants | 2027-09-07 |
Add all 2 to your calendar (.ics) → With an account.
Among the 276 studies in Pulmonary Disease, Chronic Obstructive by GlaxoSmithKline, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For participating centers (Sample 1: 30 lung specialists from Germany)
For subjects (Sample 2: 250 subjects from these 30 doctors from sample 1)
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Data from approximately 250 subjects with COPD under supervision of lung specialists enrolled in the study will be analyzed.
Other: Subject file
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.
All subject-based data will be obtained by retrospective evaluation of subject files available at the treating lung specialist.
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.
Time frame: 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.
Time frame: Up to 12 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 12 months
Number of subjects receiving current medication
Number of subjects receiving current medication will be analyzed using data from subject files.
Time frame: 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.
Time frame: Up to 12 months
Number of subjects receiving immunosuppressive treatment
Number of subjects receiving immunosuppressive treatment will be analyzed using data from subject files.
Time frame: Up to 12 months
Number of subjects receiving allergic treatment
Number of subjects receiving allergic treatment will be analyzed using data from subject files.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 12 months
Number of subjects with concomitant diseases
Number of subjects with concomitant diseases will be analyzed using data from subject files.
Time frame: Up to 12 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Apr 2018 to primary completion in Aug 2018, 4 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pulmonary Disease, Chronic Obstructive →