Microbiome and Exacerbations in Neutrophilic Asthma

Last updated: January 26, 2023
Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Overall Status: Active - Recruiting

Phase

N/A

Condition

Asthma

Treatment

N/A

Clinical Study ID

NCT04260282
IIBSP-ANE-2020-04
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age between 18 -80
  • Confirmed diagnose of asthma
  • Severe persistent asthma

Exclusion

Exclusion Criteria:

  • Respiratory infection during the previous month
  • Other significant lung disease

Study Design

Total Participants: 40
Study Start date:
January 01, 2021
Estimated Completion Date:
January 01, 2025

Study Description

See above

Connect with a study center

  • Hospital de la Santa Creu i Sant Pau. Carrer Mas Casanovas 90.

    Barcelona, 08041
    Spain

    Active - Recruiting

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