AsthmaNCT05589779
Relationship Between Cardiovascular Disease in Asthma and Eosinophil Subtypes and Biomarkers of Bronchial Remodeling.
An observational study of Asthma and Cardiovascular Diseases, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
Trial summary
To know the clinical and inflammatory characteristics of patients with asthma and associated cardiovascular disease. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Asthma, Cardiovascular Diseases
- What is being tested?
- Asthma and cardiovascular disease
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2023to 1 Aug 2024
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Asthmatic patients with and without cardiovascular disease
Who may be able to join
- Previous diagnosis of asthma
- Signed informed consent
Who cannot join
- Age under 18 years old
- Age over 99 years old
- Pneumological diseases other than asthma
- Active oncological diseases or with end of treatment <5 years
- Autoimmune or systemic inflammatory diseases
Trial locations and contacts
No sites are listed yet.
About this study
To know the clinical and inflammatory characteristics of patients with asthma and associated cardiovascular disease.
Read the detailed description
Recent studies have shown that asthma could be a risk factor for cardiovascular disease, especially in the female and late-onset subgroups. The two entities share several risk factors, such as chronic inflammation and bronchial remodeling. Eosinophilia, characteristic of asthma, has also been described as a predictor of cardiovascular mortality.
The aim of this study is to determine the clinical and inflammatory characteristics of patients with asthma and associated cardiovascular disease, as well as their relationship with eosinophil subtypes, biomarkers of chronic inflammation and bronchial remodeling.
- Conditions
- Asthma, Cardiovascular Diseases
- Being tested
- Asthma and cardiovascular disease
- Keywords
- Asthma, Cardiovascular Diseases, Chronic inflammation, Bronchial remodeling, Eosinophilia
- Medical subject headings
- Asthma, Cardiovascular Diseases, Eosinophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asthma and cardiovascular diseaseOther
To know the clinical and inflammatory characteristics of patients with asthma and associated cardiovascular disease, as well as their relationship with eosinophil subtypes, biomarkers of chronic inflammation and bronchial remodeling.
| Study group | Role | What they receive |
|---|---|---|
| With cardiovascular disease | Asthma patients with cardiovascular disease Receives: Other: Asthma and cardiovascular disease | |
| Without cardiovascular disease | Asthma patients without cardiovascular disease Receives: Other: Asthma and cardiovascular disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical characteristics of patients with asthma
Spirometry with bronchodilator testing
Measured: 1 year
Associated cardiovascular disease type
Cardiac infarction, stroke or peripheral artery disease
Measured: 1 year
Secondary outcomes (3)
Eosinophil subtypes
Eosinophil subtypes of patients with asthma and cardiovascular disease
Measured: 1 year
Biomarkers of chronic inflammation
Transforming growth factor-β, interleukin-5, interleukin-13, interleukin-25 and interleukin-3
Measured: 1 year
Bronchial remodeling
Bronchial remodeling of patients with asthma and cardiovascular disease measured by analysis of images obtained by thoracic CT scanning
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start1 Apr 2023 (estimated)
- Primary completion1 May 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05589779
- Sponsor's protocol ID
- IIBSP-ASM-2022-89
- Status last verified
- Oct 2022
- First submitted
- 10 Oct 2022
- Last updated
- 21 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Publications
Zhang B, Li ZF, An ZY, Zhang L, Wang JY, Hao MD, Jin YJ, Li D, Song AJ, Ren Q, Chen WB. Association Between Asthma and All-Cause Mortality and Cardiovascular Disease Morbidity and Mortality: A Meta-Analysis of Cohort Studies. Front Cardiovasc Med. 2022 Mar 17;9:861798. doi: 10.3389/fcvm.2022.861798. eCollection 2022.
PubMed 35369308Wang L, Gao S, Yu M, Sheng Z, Tan W. Association of asthma with coronary heart disease: A meta analysis of 11 trials. PLoS One. 2017 Jun 13;12(6):e0179335. doi: 10.1371/journal.pone.0179335. eCollection 2017.
PubMed 28609456Xu M, Xu J, Yang X. Asthma and risk of cardiovascular disease or all-cause mortality: a meta-analysis. Ann Saudi Med. 2017 Mar-Apr;37(2):99-105. doi: 10.5144/0256-4947.2017.99.
PubMed 28377538Liu H, Fu Y, Wang K. Asthma and risk of coronary heart disease: A meta-analysis of cohort studies. Ann Allergy Asthma Immunol. 2017 Jun;118(6):689-695. doi: 10.1016/j.anai.2017.03.012. Epub 2017 Apr 19.
PubMed 28433577Guite HF, Dundas R, Burney PG. Risk factors for death from asthma, chronic obstructive pulmonary disease, and cardiovascular disease after a hospital admission for asthma. Thorax. 1999 Apr;54(4):301-7. doi: 10.1136/thx.54.4.301.
PubMed 10092690Banno A, Reddy AT, Lakshmi SP, Reddy RC. Bidirectional interaction of airway epithelial remodeling and inflammation in asthma. Clin Sci (Lond). 2020 May 15;134(9):1063-1079. doi: 10.1042/CS20191309.
PubMed 32369100Lee HM, Liu MA, Barrett-Connor E, Wong ND. Association of lung function with coronary heart disease and cardiovascular disease outcomes in elderly: the Rancho Bernardo study. Respir Med. 2014 Dec;108(12):1779-85. doi: 10.1016/j.rmed.2014.09.016. Epub 2014 Oct 6.
PubMed 25448311Kannel WB, Hubert H, Lew EA. Vital capacity as a predictor of cardiovascular disease: the Framingham study. Am Heart J. 1983 Feb;105(2):311-5. doi: 10.1016/0002-8703(83)90532-x. No abstract available.
PubMed 6823813Schroeder EB, Welch VL, Couper D, Nieto FJ, Liao D, Rosamond WD, Heiss G. Lung function and incident coronary heart disease: the Atherosclerosis Risk in Communities Study. Am J Epidemiol. 2003 Dec 15;158(12):1171-81. doi: 10.1093/aje/kwg276.
PubMed 14652302Sin DD, Wu L, Man SF. The relationship between reduced lung function and cardiovascular mortality: a population-based study and a systematic review of the literature. Chest. 2005 Jun;127(6):1952-9. doi: 10.1378/chest.127.6.1952.
PubMed 15947307Rothenberg ME, Hogan SP. The eosinophil. Annu Rev Immunol. 2006;24:147-74. doi: 10.1146/annurev.immunol.24.021605.090720.
PubMed 16551246Januskevicius A, Jurkeviciute E, Janulaityte I, Kalinauskaite-Zukauske V, Miliauskas S, Malakauskas K. Blood Eosinophils Subtypes and Their Survivability in Asthma Patients. Cells. 2020 May 18;9(5):1248. doi: 10.3390/cells9051248.
PubMed 32443594Mesnil C, Raulier S, Paulissen G, Xiao X, Birrell MA, Pirottin D, Janss T, Starkl P, Ramery E, Henket M, Schleich FN, Radermecker M, Thielemans K, Gillet L, Thiry M, Belvisi MG, Louis R, Desmet C, Marichal T, Bureau F. Lung-resident eosinophils represent a distinct regulatory eosinophil subset. J Clin Invest. 2016 Sep 1;126(9):3279-95. doi: 10.1172/JCI85664. Epub 2016 Aug 22.
PubMed 27548519
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Cardiovascular Disease in Asthma and Eosinophil Subtypes and Biomarkers of Bronchial Remodeling.
- ClinicalTrials.gov ID
- NCT05589779
- Acronym / sponsor ID
- IIBSP-ASM-2022-89
- Conditions
- Asthma, Cardiovascular Diseases
- Keywords
- Asthma, Cardiovascular Diseases, Chronic inflammation, Bronchial remodeling, Eosinophilia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 21 Oct 2022 (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.
To know the clinical and inflammatory characteristics of patients with asthma and associated cardiovascular disease.
Detailed description
Recent studies have shown that asthma could be a risk factor for cardiovascular disease, especially in the female and late-onset subgroups. The two entities share several risk factors, such as chronic inflammation and bronchial remodeling. Eosinophilia, characteristic of asthma, has also been described as a predictor of cardiovascular mortality.
The aim of this study is to determine the clinical and inflammatory characteristics of patients with asthma and associated cardiovascular disease, as well as their relationship with eosinophil subtypes, biomarkers of chronic inflammation and bronchial remodeling.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With cardiovascular disease | – | Other: Asthma and cardiovascular diseaseAsthma patients with cardiovascular disease |
| Without cardiovascular disease | – | Other: Asthma and cardiovascular diseaseAsthma patients without cardiovascular disease |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Asthmatic patients with and without cardiovascular disease
Key inclusion criteria (2 listed)
- Previous diagnosis of asthma
- Signed informed consent
Key exclusion criteria (5 listed)
- Age under 18 years old
- Age over 99 years old
- Pneumological diseases other than asthma
- Active oncological diseases or with end of treatment <5 years
- Autoimmune or systemic inflammatory diseases
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 |
|---|---|---|
| Asthma and cardiovascular diseaseTo know the clinical and inflammatory characteristics of patients with asthma and associated cardiovascular disease, as well as their relationship with eosinophil subtypes, biomarkers of chronic inflammation and bronchial remodeling. | Other | With cardiovascular disease, Without cardiovascular disease |
Primary outcome
Clinical characteristics of patients with asthma
Time frame: 1 year
Spirometry with bronchodilator testing
Associated cardiovascular disease type
Time frame: 1 year
Cardiac infarction, stroke or peripheral artery disease
3 secondary outcomes
Eosinophil subtypes
Time frame: 1 year
Biomarkers of chronic inflammation
Time frame: 1 year
Bronchial remodeling
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2022.
- Results publication: PubMed 35369308Zhang B, Li ZF, An ZY, Zhang L, Wang JY, Hao MD, Jin YJ, Li D, Song AJ, Ren Q, Chen WB. Association Between Asthma and All-Cause Mortality and Cardiovascular Disease Morbidity and Mortality: A Meta-Analysis of Cohort Studies. Front Cardiovasc Med. 2022 Mar 17;9:861798. doi: 10.3389/fcvm.2022.861798. eCollection 2022.
- Results publication: PubMed 28609456Wang L, Gao S, Yu M, Sheng Z, Tan W. Association of asthma with coronary heart disease: A meta analysis of 11 trials. PLoS One. 2017 Jun 13;12(6):e0179335. doi: 10.1371/journal.pone.0179335. eCollection 2017.
- Results publication: PubMed 28377538Xu M, Xu J, Yang X. Asthma and risk of cardiovascular disease or all-cause mortality: a meta-analysis. Ann Saudi Med. 2017 Mar-Apr;37(2):99-105. doi: 10.5144/0256-4947.2017.99.
- Results publication: PubMed 28433577Liu H, Fu Y, Wang K. Asthma and risk of coronary heart disease: A meta-analysis of cohort studies. Ann Allergy Asthma Immunol. 2017 Jun;118(6):689-695. doi: 10.1016/j.anai.2017.03.012. Epub 2017 Apr 19.
- Results publication: PubMed 10092690Guite HF, Dundas R, Burney PG. Risk factors for death from asthma, chronic obstructive pulmonary disease, and cardiovascular disease after a hospital admission for asthma. Thorax. 1999 Apr;54(4):301-7. doi: 10.1136/thx.54.4.301.
- Results publication: PubMed 32369100Banno A, Reddy AT, Lakshmi SP, Reddy RC. Bidirectional interaction of airway epithelial remodeling and inflammation in asthma. Clin Sci (Lond). 2020 May 15;134(9):1063-1079. doi: 10.1042/CS20191309.
- Results publication: PubMed 25448311Lee HM, Liu MA, Barrett-Connor E, Wong ND. Association of lung function with coronary heart disease and cardiovascular disease outcomes in elderly: the Rancho Bernardo study. Respir Med. 2014 Dec;108(12):1779-85. doi: 10.1016/j.rmed.2014.09.016. Epub 2014 Oct 6.
- Results publication: PubMed 6823813Kannel WB, Hubert H, Lew EA. Vital capacity as a predictor of cardiovascular disease: the Framingham study. Am Heart J. 1983 Feb;105(2):311-5. doi: 10.1016/0002-8703(83)90532-x. No abstract available.
- Results publication: PubMed 14652302Schroeder EB, Welch VL, Couper D, Nieto FJ, Liao D, Rosamond WD, Heiss G. Lung function and incident coronary heart disease: the Atherosclerosis Risk in Communities Study. Am J Epidemiol. 2003 Dec 15;158(12):1171-81. doi: 10.1093/aje/kwg276.
- Results publication: PubMed 15947307Sin DD, Wu L, Man SF. The relationship between reduced lung function and cardiovascular mortality: a population-based study and a systematic review of the literature. Chest. 2005 Jun;127(6):1952-9. doi: 10.1378/chest.127.6.1952.
- Results publication: PubMed 16551246Rothenberg ME, Hogan SP. The eosinophil. Annu Rev Immunol. 2006;24:147-74. doi: 10.1146/annurev.immunol.24.021605.090720.
- Results publication: PubMed 32443594Januskevicius A, Jurkeviciute E, Janulaityte I, Kalinauskaite-Zukauske V, Miliauskas S, Malakauskas K. Blood Eosinophils Subtypes and Their Survivability in Asthma Patients. Cells. 2020 May 18;9(5):1248. doi: 10.3390/cells9051248.
- Individual participant dataSharing planned: Undecided. Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Cardiovascular Diseases, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 21 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esther Palones, MD (+34 93 556 56 01 ext. 5971, epalones@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical characteristics of patients with asthma (time frame: 1 year). 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?
On the ClinicalTrials.gov record for NCT05589779, which also lists 13 linked publications.
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 21 Oct 2022.