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Clinical Trials/NCT04888910
NCT04888910
Unknown
Not Applicable

Novel Inflammatory Markers in Different Phenotypes of Severe Asthma

University of Pisa1 site in 1 country80 target enrollmentMarch 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Asthma
Sponsor
University of Pisa
Enrollment
80
Locations
1
Primary Endpoint
cell receptors
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2021
End Date
February 28, 2023
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ilaria Puxeddu

Associate Professor

University of Pisa

Eligibility Criteria

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

Outcomes

Primary Outcomes

cell receptors

Time Frame: 2 years

to identify neutrophil- and eosinophil-receptors in the airways of severe asthmatic patients with or without involvement of the upper airways

cell mediators

Time Frame: 2 years

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

Study Sites (1)

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