| Registry | NCT03479138, acronym ANNE |
|---|---|
| Status | Completed |
| Study type | Observational |
| Enrollment | 10 (Actual) |
| Sponsor | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (Other); collaborators: Spanish Clinical Research Network - SCReN |
| Conditions | Neutrophilic Asthma |
| Interventions | Induced sputum (Diagnostic test) |
| Dates | start 2018-02-21, primary completion 2023-06-30, completion 2023-07-30, first posted 2018-03-27, last updated 2024-01-11 |
| Locations | 2 sites in Spain |
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All trials for Neutrophilic Asthma All trials of Induced sputum
Define and characterize the neutrophilic phenotype of severe asthma.
Neutrophilic asthma (NA) is the asthma phenotype less known, causes a severe disease and does not have a specific treatment. Research on the neutrophilia mechanisms, new neutrophil (NEU) types and bronchial microbiome, can provide an opportunity to better understand the NA pathogenesis.
OBJECTIVES: 1. To describe the clinical characteristics of NA and its sub-phenotypes (SUBSTUDY 1); 2. To determine the NEU types associated with the NA and its sub-phenotypes (SUBSTUDY 2); and 3. To identify the bronchial microbiological flora of the NA, specifically related to lung microbiome and the immune response against Chlamydia Pneumoniae (SUBSTUDY 3).
METHODS: Multicenter prospective study including 100 patients with severe asthma (GINA/GEMA criteria): 50 with non-neutrophilic asthma (<65% NEU in induced sputum \[IS\]); and 50 with NA (> 64% NEU in IS). SUBSTUDY 1: clinical variables (years of evolution, exacerbations, asthma control test, mini asthma quality of life questionnary), comorbidities (GERD, nasal polyposis, obesity, ASS), pulmonary function (FEV1, exhaled fraction of nitric oxide, total lung capacity, Aspergillus), prick-test and CT scan chest; SUBSTUDY 2 (in IS and plasma): apoptotic index by means NE culture and flux cytometer (Annexin-V-FITC), NEU phenotype by surface markers (CD16, CD66b, CD62L, HLADR, CD177, CD11b, CD63, CXCR2, CXCR4) with density gradient study and determination of cytokines (IL-6, IL-8, IL-17, IL-1, IL-22) by ELISA; SUBSTUDY 3 (in IS): bronchial microbiome for 16 subunit rRNA by Phylogenetic Investigation of Communities by Reconstruction of Unobserved States (PICRUSt), and anti-Chlamydia Pneumoniae Immunoglobuling A by ELISA.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Neutrophilic asthma | Diagnostic Test: Induced sputum | Patients 18 to 80 years old diagnosed of severe asthma, requiring treatment at least with long acting beta agonists (LABA) + high doses inhaled corticosteroids (ICS) with eosinophil count in blood<300/mm3. They must be ex-smokers with less than 10 packs-year and no other relevant pulmonary disease. | |
| Non neutrophilic asthma | Diagnostic Test: Induced sputum | Patients 18 to 80 years old diagnosed of severe asthma, requiring treatment at least with LABA+ high doses ICS, with eosinophil count in blood<300/mm3. They must be ex-smokers with less than 10 packs-year and no other relevant pulmonary disease. |
Sex: All, ages: 18 Years to 80 Years
Inclusion Criteria: * 18 - 80 years old * Confirmed diagnosis of asthma (according to spanish guideline GEMA) * Severe persistent asthma (step 5-6 GEMA) * Eosinophils<300/mm3 in peripheral blood Exclusion Criteria: * Respiratory infection during the previous month * Significant lung pathology not attributable to asthma (bronchiectasis with Reiff score>3)
| Facility | City | Country | Status |
|---|---|---|---|
| Hospital de la Santa Creu i Sant Pau. Carrer Mas Casanovas 90. | Barcelona | Spain | |
| Hospital de la Santa Creu i Sant Pau | Barcelona | Spain |