Non-Eosinophilic Neutrophilic Asthma
Atslēgvārdi
Abstrakts
Apraksts
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, ACT, miniAQLQ), comorbidities (GERD, nasal polyposis, obesity, ASS), pulmonary function (FEV1, FENO, TLC, 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, HLA-DR, 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 16S rRNA by PICRUSt, and anti-Chlamydia Pneumoniae IgA by ELISA.
Datumi
| Pēdējoreiz pārbaudīts: | 02/28/2018 |
| Pirmais iesniegtais: | 03/13/2018 |
| Paredzētā reģistrācija iesniegta: | 03/19/2018 |
| Pirmais izlikts: | 03/26/2018 |
| Pēdējais atjauninājums iesniegts: | 03/19/2018 |
| Pēdējā atjaunināšana ievietota: | 03/26/2018 |
| Faktiskais studiju sākuma datums: | 02/20/2018 |
| Paredzamais primārās pabeigšanas datums: | 09/29/2020 |
| Paredzamais pētījuma pabeigšanas datums: | 12/29/2020 |
Stāvoklis vai slimība
Iejaukšanās / ārstēšana
Diagnostic Test: Induced sputum
Fāze
Roku grupas
| Roka | Iejaukšanās / ārstēšana |
|---|---|
| Neutrophilic asthma 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. | |
| Non neutrophilic asthma 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. |
Atbilstības kritēriji
| Vecums, kas piemērots studijām | 18 Years Uz 18 Years |
| Dzimumi, kas ir piemēroti studijām | All |
| Paraugu ņemšanas metode | Non-Probability Sample |
| Pieņem veselīgus brīvprātīgos | Jā |
| Kritēriji | 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) |
Rezultāts
Primārie rezultāti
1. Phenotype of neutrophils [24 hours]
2. Microbiome analysis [6 months]
Sekundārie iznākuma mērījumi
1. Clinical demographic characteristics [1 year]
2. Demographic characteristics [1 year]
