AsmaEx: Microbiome and Exacerbations in Neutrophilic Asthma

Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (Other)
Overall Status
Recruiting
CT.gov ID
NCT04260282
Collaborator
Sociedad Española de Neumología y Cirugía Torácica (Other), GlaxoSmithKline (Industry)
40
1
24
1.7

Study Details

Study Description

Brief Summary

Neutrophilic asthma (NA) is the least known severe asthma phenotype. It is associated with more exacerbations, worse control and impaired lung function. One of its possible etiologies is bronchial infections. The study of bronchial microbiology and its relationship with exacerbations is a new line of research.

Objectives: 1) To analyze bronchial microbiome in patients with AN and non-neutrophilic (ANN), with frequent exacerbations and without exacerbations. 2) To relate the presence of bronchial infections with differences in the microbiome. 3) Correlate the characteristics of the microbiome with other evidence used in exacerbations.

Methods: Prospective study involving 40 non-smoking asthmatics without bronchiectasis (20 with AN and 20 with ANN). Of these, 10 in each group will have frequent exacerbations (>2 rounds of systemic steroids in the last year, of >3 days each) and 10 non- frequent exacerbations. AN will be defined as >65% neutrophils in stable phase sputum. All patients will have two stable visits in which clinical variables, asthma control, lung function and induced sputum samples will be collected (for analysis of bronchial inflammatory cell count and for the study of the microbiome by 16 subunit rRNA). Specific Immunoglobulin A (IgA) for Chlamydia Pneumoniae will be determined. In exacerbations, sputum samples will be collected for culture and nasopharyngeal smears for the study of major respiratory viruses and bacteria by multiple polymerase chain reaction.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Polymerase Chain Reaction (PCR) for viruses and bacteria in nasal swab
  • Diagnostic Test: Induced sputum microbiome

Detailed Description

See above

Study Design

Study Type:
Observational
Anticipated Enrollment :
40 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Exacerbations in Neutrophilic Asthma: Influence of Bronchial Microbiome
Actual Study Start Date :
Jan 1, 2021
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Neutrophilic asthma

Patients with asthma diagnosed according to guidelines, with eosinophils <300/mm3 in blood and <3% in induced sputum

Diagnostic Test: Polymerase Chain Reaction (PCR) for viruses and bacteria in nasal swab
PCR for viruses and bacteria in nasal swab

Diagnostic Test: Induced sputum microbiome
Microbiome in induced sputum

Eosinophilic asthma

Patients with asthma diagnosed according to guidelines, with eosinophils >300/mm3 in blood and/or >3% in induced sputum

Diagnostic Test: Polymerase Chain Reaction (PCR) for viruses and bacteria in nasal swab
PCR for viruses and bacteria in nasal swab

Diagnostic Test: Induced sputum microbiome
Microbiome in induced sputum

Outcome Measures

Primary Outcome Measures

  1. Differences between neutrophilic and non-neutrophilic asthma, with and without frequent exacerbations in bronchial microbiome using 16S rDNA sequencing [6 months]

    Qualitative and quantitative analysis of bronchial microbiome in patients including bacterial communities and major bacterial phyla in neutrophilic and non-neutrophilic asthma, with frequent exacerbations and without exacerbations.

Secondary Outcome Measures

  1. Changes in absolute and relative abundance using 16S rDNA sequencing of bronchial microbiota due to asthma exacerbations, in patients with neutrophilic and eosinophilic asthma [1 year]

    Influence of bronchial infections in qualitative and quantitative characteristics of lung microbiome. (Bacterial communities and major bacterial phyla)

  2. Changes in absolute and relative abundance of bronchial microbiota over a year using 16S rDNA sequencing [1 year]

    Qualitative and quantitative changes of lung microbiome (Bacterial communities and major bacterial phyla)

  3. Relationship between lung microbiome andlevels of specific immunoglobulin A of C. pneumoniae, PCR, and immunoglobulin G of aspergillus [6 months]

    Relationship between qualitative and quantitative characteristics of lung microbiome with levels of specific IgA C. pneumoniae, PCR, IgG aspergillus

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Age between 18 -80

  • Confirmed diagnose of asthma

  • Severe persistent asthma

Exclusion Criteria:
  • Respiratory infection during the previous month

  • Other significant lung disease

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital de la Santa Creu i Sant Pau. Carrer Mas Casanovas 90. Barcelona Spain 08041

Sponsors and Collaborators

  • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
  • Sociedad Española de Neumología y Cirugía Torácica
  • GlaxoSmithKline

Investigators

  • Principal Investigator: Astrid Crespo, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier:
NCT04260282
Other Study ID Numbers:
  • IIBSP-ANE-2020-04
First Posted:
Feb 7, 2020
Last Update Posted:
Oct 8, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 8, 2021