Clinical trial NCT04260282: Microbiome and Exacerbations in Neutrophilic Asthma
Official title: Exacerbations in Neutrophilic Asthma: Influence of Bronchial Microbiome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Asthma
Microbiome
Exacerbation
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
Collaborators: name: Sociedad Española de Neumología y Cirugía Torácica
name: GlaxoSmithKline
First posted: 2020-02-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Severe asthma according to guidelines, 18-80 years

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.

Detailed description: See above

Eligibility criteria: 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

Primary outcomes:
measure: Differences between neutrophilic and non-neutrophilic asthma, with and without frequent exacerbations in bronchial microbiome using 16S rDNA sequencing
timeFrame: 6 months
Secondary outcomes:
measure: Changes in absolute and relative abundance using 16S rDNA sequencing of bronchial microbiota due to asthma exacerbations, in patients with neutrophilic and eosinophilic asthma
timeFrame: 1 year
measure: Changes in absolute and relative abundance of bronchial microbiota over a year using 16S rDNA sequencing
timeFrame: 1 year
measure: Relationship between lung microbiome andlevels of specific immunoglobulin A of C. pneumoniae, PCR, and immunoglobulin G of aspergillus
timeFrame: 6 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau. Carrer Mas Casanovas 90.
Study officials:
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Astrid Crespo
role: PRINCIPAL_INVESTIGATOR
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