Microbiome and Exacerbations in Neutrophilic Asthma

NCT ID: NCT04260282

Last Updated: 2023-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2025-01-01

Brief Summary

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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.

Detailed Description

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See above

Conditions

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Asthma Microbiome Exacerbation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Neutrophilic asthma

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

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

Intervention Type DIAGNOSTIC_TEST

PCR for viruses and bacteria in nasal swab

Induced sputum microbiome

Intervention Type DIAGNOSTIC_TEST

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

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

Intervention Type DIAGNOSTIC_TEST

PCR for viruses and bacteria in nasal swab

Induced sputum microbiome

Intervention Type DIAGNOSTIC_TEST

Microbiome in induced sputum

Interventions

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

PCR for viruses and bacteria in nasal swab

Intervention Type DIAGNOSTIC_TEST

Induced sputum microbiome

Microbiome in induced sputum

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sociedad Española de Neumología y Cirugía Torácica

OTHER

Sponsor Role collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Astrid Crespo

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Barcelona, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Astrid Crespo, PhD

Role: CONTACT

932919000 ext. 7684

Facility Contacts

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Astrid Crespo, MD

Role: primary

+34-935565972

References

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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Other Identifiers

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IIBSP-ANE-2020-04

Identifier Type: -

Identifier Source: org_study_id

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