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NCT04888910
Novel Inflammatory Markers in Different Phenotypes of Severe Asthma
trial testing observational in Asthma in 80 participants. Status unknown.
31 August 2022
Quick facts
| Lead sponsor | University of Pisa |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 80 |
| Start date | 1 March 2021 |
| Primary completion | 31 August 2022 |
| Estimated completion | 28 February 2023 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- observational — full drug profile →
Conditions studied
- Asthma — all drugs for Asthma →
- Nasal Polyps — all drugs for Nasal Polyps →
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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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04888910 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Pisa
- Last refreshed: 21 May 2021
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