An observational study in Pulmonary Disease, Chronic Obstructive, sponsored by GlaxoSmithKline. Completed at 4 sites in Spain. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2019-01-29.
Sponsored by GlaxoSmithKline · Observational
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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 31st largest by enrollment of the 40 observational ones that give a count, is one of 18 that started in 2017, is one of 40 observational ones, and was the 247th 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: 40 Years and older · all sexes · no healthy volunteers.
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. 18 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 341 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.
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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 observational study is designed to more specifically describe the burden of the disease and the use of healthcare resources of subjects with eosinophilic COPD that may be eligible in the future for a biologic treatment. Subjects who attend a routine follow-up visit and fulfill the inclusion/exclusion criteria defined provide a signed informed consent will be invited by the investigator to participate in this study. Subjects will be recruited in hospital Pulmonology Services across Spain. It is planned to include approximately 20 centers. To select the final participating centers, a feasibility study has been carried out in approximately 50 potential participating centers. It has been estimated that each investigator will include 18 subjects during the 4-month inclusion period. Total 354 subjects will be required: 250 subjects with an eosinophil level >=150 cells per microliter and 104 subjects with an eosinophil level \<150 cells per microliter. The study inclusion period will be 4 months (expected to be from November 2017 to March 2018) and the retrospective data collection period will be 12 months prior to the inclusion visit.
Subjects who attend a routine follow-up visit and who fulfill inclusion/exclusion criteria will be invited by the investigator to participate in the study. The study inclusion period will be four months (from November 2017 to March 2018) and the retrospective data collection period will be 12 months prior to the inclusion visit.
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.
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.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
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.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Subjects with a COPD diagnosis confirmed with a post-bronchodilator Forced Expiratory Volume in 1 second/Forced Vital capacity \<70% recorded at any time in the medical record who have a qualifying peripheral blood eosinophil test recorded in the 3 months prior to the inclusion visit attend to a routine follow-up visit during the inclusion period, fulfill the inclusion/exclusion criteria and provide informed consent to participate, will be included in this study.
Number of subjects requiring COPD maintenance treatment and rescue medication
Subjects currently exposed to inhaled triple maintenance therapy, defined as at least one overlapping prescription of an inhaled corticosteroid (ICS) with a long-acting beta2-agonist (LABA) and with a long-acting muscarinic antagonist (LAMA) in 2 or 3 inhaler devices, without more than 30 days of separation between prescriptions along with rescue medication use will be analyzed.
Time frame: 12 months prior to the inclusion visit
Number of subjects with moderate and severe exacerbations
Subjects who have experienced \>=2 moderate exacerbations or \>=1 severe exacerbation in the 12 months prior to the inclusion visit. Moderate exacerbation is defined as an exacerbation requiring antibiotics and/or oral corticosteroids or requiring an emergency visit \<24 hours (without hospitalization). Severe exacerbation is defined as an exacerbation requiring hospitalization.
Time frame: 12 months prior to the inclusion visit
Number of subjects with COPD-related scheduled and unscheduled primary and secondary care visits
Subjects with COPD-related scheduled and unscheduled primary and secondary care visits will be analyzed.
Time frame: 12 months prior to the inclusion visit
Number of subjects with COPD-related emergency visits to primary care and hospital
Subjects with COPD-related emergency visits to primary care and hospital will be analyzed.
Time frame: 12 months prior to the inclusion visit
Number of subjects with COPD-related hospitalizations
Subjects with COPD-related hospitalizations will be analyzed.
Time frame: 12 months prior to the inclusion visit
Number of days of hospitalizations
The number of days of hospitalization for subjects will be analyzed.
Time frame: 12 months prior to the inclusion visit
Number of subjects with COPD-related complementary tests
Subjects with COPD-related complementary tests will be analyzed.
Time frame: 12 months prior to the inclusion visit
Number of subjects with COPD-related days-off work
Subjects with COPD-related days-off work will be analyzed.
Time frame: 12 months prior to the inclusion visit
Subjects age as a measure of sociodemographic characteristics
Age will be recorded for descriptive analysis of the sociodemographic characteristics of the subjects participating in the study. A threshold of \>=150 cells/microliter will be considered to determine a high level of eosinophil's, so only subjects meeting this criterion will be included in the analysis.
Time frame: 4 months (inclusion period)
Number of subjects with different gender
Gender will be recorded for descriptive analysis of the sociodemographic characteristics of the subjects participating in the study. A threshold of \>=150 cells/microliter will be considered to determine a high level of eosinophil's, so only subjects meeting this criterion will be included in the analysis.
Time frame: 4 months (inclusion period)
Number of subjects with different sociodemographic variables
Subjects with different educational level, employment status, monthly net income will be recorded for descriptive analysis of the sociodemographic characteristics of the subjects participating in the study A threshold of \>=150 cells/microliter will be considered to determine a high level of eosinophil's, so only subjects meeting this criterion will be included in the analysis.
Time frame: 4 months (inclusion period)
Number of subjects with abnormal clinical variables
Clinical variables comprising weight, height, body mass index (self-calculated), smoking history, Charlson comorbidity index, diagnosis of asthma will be assessed for abnormalities. A threshold of \>=150 cells/microliter will be considered to determine a high level of eosinophil's, so only subjects meeting this criterion will be included in the analysis.
Time frame: 4 months (inclusion period)
Number of subjects with abnormal COPD related variables
COPD variables comprising COPD diagnosis date, pulmonary function with bronchodilator test, modified Medical Research Council (mMRC) dyspnea scale, clinical phenotypes according to Spanish COPD Clinical Guidelines (GesEPOC) criteria will be assessed for abnormalities. A threshold of \>=150 cells/microliter will be considered to determine a high level of eosinophil's, so only subjects meeting this criterion will be included in the analysis.
Time frame: 12 months prior to the inclusion visit
Number of subjects with abnormal blood cell count
Peripheral blood eosinophil count, peripheral blood neutrophil count, peripheral blood leukocyte count, fibrinogen and red cell distribution width will be assessed for abnormalities.
Time frame: 12 months prior to the inclusion visit
COPD Assessment Test (CAT) score as a measure of Health Related Quality of Life (HRQoL)
The CAT questionnaire is a COPD-specific questionnaire that measures the impact of the disease on HRQoL and allows symptoms to be described. It consists of 8 items, which yield a score range from 0 to 40, 0 representing the lowest impact on HRQoL and 40 the maximum impact.
Time frame: 4 months (inclusion period)
EuroQOL five dimensions five level (EQ-5D-5L) score as a measure of HRQoL
The EQ-5D-5L is a preference-based generic HRQoL questionnaire, consisting on five health dimensions (mobility, personal care, daily activities, pain/discomfort and anxiety/depression), divided in five levels of severity (no problems, slight problems, moderate problems, severe problems and extreme problems). It included also a visual analogue scale (VAS) in which respondents are asked to evaluate their overall health status on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).
Time frame: 4 months (inclusion period)
Ran from Dec 2017 to primary completion in Oct 2018, 10 months.
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This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive →