- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04888910
Novel Inflammatory Markers in Different Phenotypes of Severe Asthma
Asthma is a highly prevalent chronic airway inflammatory disease characterized by airway hyper-responsiveness, reversible airflow obstruction and increased mucus secretion, involving large and small airways. An emerging sub-phenotype of severe asthma is the late onset disease associated with nasal polyposis, a frequent co-morbidity that significantly impacts lung function and symptom control. On the basis of the infiltrate found in the sputum, asthma can be divided into four distinct phenotypes: eosinophilic, neutrophilic, mixed granulocytic and pauci-granulocytic. The majority of patients with eosinophilic asthma are sensitive to corticosteroids, and biological therapies targeting eosinophils (anti-Interleukin (IL)-5 and anti-IL5R) have been recently approved. However, it is known that some asthmatics, particularly those who have severe disease and are resistant to corticosteroids, have elevated neutrophil counts in the airway where they play a vital role in the exacerbation of the disease. However, the precise role of neutrophils in severe asthma and the mechanisms involved in neutrophil-induced tissue damage have not been clarified yet.
The hypothesis of the study is that neutrophils and eosinophils can contribute to the severity of asthma by changing their phenotypes according to the airway environment. Thus, a better understanding of the roles of neutrophils and eosinophils in severe asthma may lead to the identification of novel biomarkers and the development of new therapeutic approaches in different phenotypes of severe asthma.
Studieoversikt
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiekontakt
- Navn: Ilaria Puxeddu, MD, PhD
- Telefonnummer: +393394740912
- E-post: ilaria.puxeddu@unipi.it
Studiesteder
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Tuscany
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Pisa, Tuscany, Italia, 56126
- Rekruttering
- Pisa University
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Ta kontakt med:
- Ilaria Puxeddu, MD, PhD
- Telefonnummer: +393394740912
- E-post: ilaria.puxeddu@unipi.it
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Male or female
- age (18-65 years)
- Diagnosis of severe asthma according to the European Respiratory Society (ERS) and American Thoracic Society (ATS) definition, with and without nasal symptoms
- normal pulmonary function post-therapy (FEV1 post-bronchodilation: greater than 80% of the predicted value, with FEV1/ vital capacity (VC) > 88-89% - for males and females, respectively - of the predicted value)
- non reversible chronic airflow limitation (FEV1 post-bronchodilation: lower than 70% of the predicted value, with FEV1/VC < 88-89% of the predicted value)
- Signing of the informed consent
Exclusion Criteria:
- Referred Pregnancy
- Use of therapy with beta-blockers
- Smoking (current or within the previous 3 months)
- Negation to participate to the study
- Current upper and lower airways infectious diseases
- Current systemic infectious diseases
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
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asthma with nasal polyps
severe asthma with involvement of the upper airways (chronic rhinosinusitis with nasal polyps)
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observation of biomarkers in different asthma groups
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severe asthma without nasal polyps
severe asthma without involvement of the upper airways
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observation of biomarkers in different asthma groups
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
cell receptors
Tidsramme: 2 years
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to identify neutrophil- and eosinophil-receptors in the airways of severe asthmatic patients with or without involvement of the upper airways
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2 years
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cell mediators
Tidsramme: 2 years
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to identify soluble and matrix-derived mediators from neutrophils and eosinophils in the airways of severe asthmatic patients with or without involvement of the upper airways
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2 years
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Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Wu W, Bleecker E, Moore W, Busse WW, Castro M, Chung KF, Calhoun WJ, Erzurum S, Gaston B, Israel E, Curran-Everett D, Wenzel SE. Unsupervised phenotyping of Severe Asthma Research Program participants using expanded lung data. J Allergy Clin Immunol. 2014 May;133(5):1280-8. doi: 10.1016/j.jaci.2013.11.042. Epub 2014 Feb 28.
- Wenzel SE, Jayawardena S, Graham NM, Pirozzi G, Teper A. Severe asthma and asthma-chronic obstructive pulmonary disease syndrome - Authors' reply. Lancet. 2016 Dec 3;388(10061):2742. doi: 10.1016/S0140-6736(16)31720-2. Epub 2016 Dec 2. No abstract available.
- Ray A, Kolls JK. Neutrophilic Inflammation in Asthma and Association with Disease Severity. Trends Immunol. 2017 Dec;38(12):942-954. doi: 10.1016/j.it.2017.07.003. Epub 2017 Aug 4.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- NIMISA
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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