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Clinical Trials/NCT03479138
NCT03479138CompletedNot Applicable

Non-Eosinophilic Neutrophilic Asthma

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau2 sites in 1 country10 target enrollmentStarted: February 21, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
10
Locations
2
Primary Endpoint
Phenotype of neutrophils

Study Overview

Brief Summary

Define and characterize the neutrophilic phenotype of severe asthma.

Detailed Description

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Outcomes

Primary Outcomes

Phenotype of neutrophils

Time Frame: 24 hours

To determine the types of neutrophils (in induced sputum and blood) associated with neutrophilic asthma and its subphenotypes according to flow cytometry

Microbiome analysis

Time Frame: 6 months

To analyse the bronchial microbiological flora of neutrophilic asthma

Secondary Outcomes

  • Demographic characteristics(1 year)
  • Clinical demographic characteristics(1 year)

Investigators

Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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