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NCT04888910

Novel Inflammatory Markers in Different Phenotypes of Severe Asthma

Status unknown Last updated 21 May 2021
What this trial tests

trial testing observational in Asthma in 80 participants. Status unknown.

Timeline
1 March 2021
Primary endpoint
31 August 2022
28 February 2023

Quick facts

Lead sponsorUniversity of Pisa
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment80
Start date1 March 2021
Primary completion31 August 2022
Estimated completion28 February 2023
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

Sponsor

University of Pisa

Who can join

Adults 18 to 65, any sex, with Asthma or Nasal Polyps. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Trials testing the same drug.

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Trials by the same sponsor.

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Data sources for this page

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