Microbiome and Exacerbations in Neutrophilic Asthma (AsmaEx)

January 26, 2023 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Exacerbations in Neutrophilic Asthma: Influence of Bronchial Microbiome

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

See above

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Barcelona, Spain, 08041
        • Recruiting
        • Hospital de la Santa Creu i Sant Pau. Carrer Mas Casanovas 90.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Severe asthma according to guidelines, 18-80 years

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences between neutrophilic and non-neutrophilic asthma, with and without frequent exacerbations in bronchial microbiome using 16S rDNA sequencing
Time Frame: 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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in absolute and relative abundance using 16S rDNA sequencing of bronchial microbiota due to asthma exacerbations, in patients with neutrophilic and eosinophilic asthma
Time Frame: 1 year
Influence of bronchial infections in qualitative and quantitative characteristics of lung microbiome. (Bacterial communities and major bacterial phyla)
1 year
Changes in absolute and relative abundance of bronchial microbiota over a year using 16S rDNA sequencing
Time Frame: 1 year
Qualitative and quantitative changes of lung microbiome (Bacterial communities and major bacterial phyla)
1 year
Relationship between lung microbiome andlevels of specific immunoglobulin A of C. pneumoniae, PCR, and immunoglobulin G of aspergillus
Time Frame: 6 months
Relationship between qualitative and quantitative characteristics of lung microbiome with levels of specific IgA C. pneumoniae, PCR, IgG aspergillus
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

GlaxoSmithKline
Sociedad Española de Neumología y Cirugía Torácica

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Anticipated)

January 1, 2024

Study Completion (Anticipated)

January 1, 2025

Study Registration Dates

First Submitted

January 23, 2020

First Submitted That Met QC Criteria

February 5, 2020

First Posted (Actual)

February 7, 2020

Study Record Updates

Last Update Posted (Estimate)

January 30, 2023

Last Update Submitted That Met QC Criteria

January 26, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIBSP-ANE-2020-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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