Microbiome and Exacerbations in Neutrophilic Asthma

NCT04260282 | Unknown

• 1 other identifier: IIBSP-ANE-2020-04
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Microbiome; Exacerbation

Outcome Measures

Primary Outcomes (1)

• Differences between neutrophilic and non-neutrophilic asthma, with and without frequent exacerbations in bronchial microbiome using 16S rDNA sequencing

  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.

  6 months

Secondary Outcomes (3)

• 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

• Changes in absolute and relative abundance of bronchial microbiota over a year using 16S rDNA sequencing

  1 year

• Relationship between lung microbiome andlevels of specific immunoglobulin A of C. pneumoniae, PCR, and immunoglobulin G of aspergillus

  6 months

Study Arms (2)

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; Diagnostic Test: Induced sputum microbiome

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; Diagnostic Test: Induced sputum microbiome

Interventions

Polymerase Chain Reaction (PCR) for viruses and bacteria in nasal swab DIAGNOSTIC_TEST

PCR for viruses and bacteria in nasal swab

Eosinophilic asthma; Neutrophilic asthma

Induced sputum microbiome DIAGNOSTIC_TEST

Microbiome in induced sputum

Eosinophilic asthma; Neutrophilic asthma

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Severe asthma according to guidelines, 18-80 years

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

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

Barcelona, 08041, Spain

RECRUITING

Related Publications (15)

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  PMID: 25215528 BACKGROUND

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  PMID: 15528712 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Induced sputum Nasal swab

MeSH Terms

Conditions

Asthma

Interventions

Bacterial Load

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Bacteriological Techniques; Microbiological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Colony Count, Microbial; Investigative Techniques; Bacterial Physiological Phenomena; Microbiological Phenomena

Study Officials

• Astrid Crespo

  Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Astrid Crespo, PhD

CONTACT

932919000; acrespo@santpau.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2020
• First Posted: February 7, 2020
• Study Start: January 1, 2021
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2025
• Last Updated: January 30, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)