An observational study in Asthma, Microbiome and Exacerbation, sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau. Status unknown at 1 site in Spain. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-01-30.
Sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Observational
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.
See above
3,920 studies on the registry are indexed under Asthma; 506 are open to participants now.
This study's planned enrollment of 40 is below the median of 150 across 970 observational studies indexed under Asthma.
Browse Asthma studies →Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau is the lead sponsor of 335 studies on the registry; 64 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Severe asthma according to guidelines, 18-80 years
Exclusion Criteria:
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
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
PCR for viruses and bacteria in nasal swab
Microbiome in induced sputum
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.
Time frame: 6 months
Changes in absolute and relative abundance using 16S rDNA sequencing of bronchial microbiota due to asthma exacerbations, in patients with neutrophilic and eosinophilic asthma
Influence of bronchial infections in qualitative and quantitative characteristics of lung microbiome. (Bacterial communities and major bacterial phyla)
Time frame: 1 year
Changes in absolute and relative abundance of bronchial microbiota over a year using 16S rDNA sequencing
Qualitative and quantitative changes of lung microbiome (Bacterial communities and major bacterial phyla)
Time frame: 1 year
Relationship between lung microbiome andlevels of specific immunoglobulin A of C. pneumoniae, PCR, and immunoglobulin G of aspergillus
Relationship between qualitative and quantitative characteristics of lung microbiome with levels of specific IgA C. pneumoniae, PCR, IgG aspergillus
Time frame: 6 months
Plan to share: No
This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau