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Novel Inflammatory Markers in Different Phenotypes of Severe Asthma

Novel Inflammatory Markers in Different Phenotypes of Severe Asthma

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04888910
Enrollment
80
Registered
2021-05-17
Start date
2021-03-01
Completion date
2023-02-28
Last updated
2021-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, Nasal Polyps

Keywords

asthma, eosinophils, neutrophils

Brief summary

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.

Interventions

OTHERobservational

observation of biomarkers in different asthma groups

Sponsors

University of Pisa
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
cell receptors2 yearsto identify neutrophil- and eosinophil-receptors in the airways of severe asthmatic patients with or without involvement of the upper airways
cell mediators2 yearsto 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

Countries

Italy

Contacts

Primary ContactIlaria Puxeddu, MD, PhD
ilaria.puxeddu@unipi.it+393394740912

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026