An observational study in Chronic Obstructive Pulmonary Disease (COPD), sponsored by Barcelona Institute for Global Health. Recruiting at 3 sites in 3 countries. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2024-05-20.
Sponsored by Barcelona Institute for Global Health · Observational
This work is a multicentric prospective cohort study designed to improve chronic obstructive pulmonary disease (COPD) treatment and management. The study involves 150 patients diagnosed with COPD who are at risk of exacerbations. These patients are recruited from three tertiary hospitals in Spain, Germany, and Italy. The study will last 18 months, with a 12-month follow-up duration for each patient. The primary objective of this study is to develop and test Artificial Intelligence (AI)-based models that can predict moderate-to-severe COPD exacerbations early on. This will be done by analyzing daily-life data collected from unobtrusive sensors that monitor patients' psycho-physiological and environmental signals. By accurately predicting exacerbations, the study aims to support clinicians in providing more precise, optimized, and personalized treatment to COPD patients. A secondary objective is to train and test AI-based models to estimate the 12-month dynamics of health-related quality of life (HRQoL) in COPD patients. This will involve analyzing data related to the patients' functional exercise capacity, dyspnea (difficulty breathing), and health-related quality of life, as measured by the Clinical COPD Questionnaire (CCQ) score and the COPD Assessment Test (CAT) score.
5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.
This study's planned enrollment of 150 is close to the median of 158 across 1,497 observational studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Barcelona Institute for Global Health is the lead sponsor of 24 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
This study targets COPD patients at risk of moderate-to-severe exacerbations. Participants will be recruited from three European tertiary care hospitals: Hospital del Mar in Barcelona, Spain; the Pulmonary Research Institute in Grosshansdorf, Germany; and Azienda Ospedaliera Universitaria Pisana in Pisa, Italy. Recruitment sources include research registers, hospital records, and referrals.
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.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
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.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will be equipped with unobtrusive devices for a duration of 12 months. Throughout this period, they will attend scheduled visits every three months following the baseline visit. These assessments will focus on determining the frequency of exacerbations, evaluating exercise capacity, measuring the severity of dyspnea, and assessing health-related quality of life. The data gathered from the sensors embedded in these unobtrusive devices will be instrumental in developing AI-based models. These models aim to accurately predict COPD exacerbations and effectively estimate the progression of the previously mentioned health outcome.
Occurrence of moderate-to-severe COPD exacerbations
Occurrence of moderate-to-severe COPD exacerbations at months 3, 6, 9, and 12, through medical records
Time frame: Months 3, 6, 9, and 12
Changes in the health-related quality of life
Health-related quality of life at baseline, months 3, 6, 9, and 12, using the Clinical COPD Questionnaire (CCQ) and the COPD Assessment Test (CAT). The CCQ score ranges from 0 to 6, and the CAT score ranges from 0 to 40. Both questionnaires use higher scores to indicate a more severe impact of COPD on a patient's life.
Time frame: Baseline, Month 3, 6, 9 and 12
Changes in the functional exercise capacity
Changes in the functional exercise capacity at baseline, month 3, 6, 9 and 12, as measured by the Six-minute walking distance
Time frame: Baseline, Month 3, 6, 9 and 12
Changes in the dyspnoea severity grade
Changes in the dyspnoea severity grade at baseline, month 3, 6, 9, and 12, as measured by the modified Medical Research Council (MRC) Dyspnoea scale. The mMRC Dyspnoea scale ranges from 0 to 4, with higher scores indicating more severe dyspnea.
Time frame: Baseline, Month 3, 6, 9 and 12
Started May 2024 (actual). Primary completion is estimated for Jul 2024, 2 months after the start.
Of 466 non-industry observational studies under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 64. This study's planned 2 months is below that.
Counting every sponsor, half of 586 studies reached it within 26 months; a quarter within 14 and three quarters within 58.
How these figures are worked out, and which studies are left out of them.
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Pulmonary Disease, Chronic Obstructive →
Barcelona Institute for Global Health