Clinical trial

The Role of the Lung Microbiome in Asthma and Its Influence on Treatment Response.

Name
23.29
Description
The goal of this observational study is to investigate the role of the lung microbiome in patients with asthma and how it may influence the response to asthma specific treatments. This will be compared to patients who presented similarly but do not have a diagnosis of asthma. The main aims are to: 1. Evaluate the influence of the microbiome on asthma phenotypes 2. Evaluate the influence of the microbiome on respiratory physiological change 3. Evaluate the effect of asthma treatment on the microbiome and the host response Participants will be asked to provide a medical history focusing on their asthma and related co-morbidities such as sinus and reflux disease. They will have physiological parameters measured (spirometry, impulse oscillometry, fraction of exhaled nitric oxide). They will have samples collected to assess the upper and lower airway microbiome (oral rinse, nasopharyngeal swab, sputum, exhaled breath condensate and bronchoscopy) as well as the gut microbiome (stool). They will also have serum samples taken to perform host immune profiling (host transcriptome). They will be followed over six months observing how changes to asthma specific treatments, particularly inhaled corticosteroids and biologic agents can affect the microbiome
Trial arms
Trial start
2023-10-01
Estimated PCD
2025-07-01
Trial end
2025-07-01
Status
Not yet recruiting
Treatment
Biologic Agent
Biologic group will have biological agent commenced if considered necessary as part of routine care.
Arms:
Biologic Group
Size
60
Primary endpoint
Describe microbiome signature across the spectrum of asthma severity
2 years
Establish if there is any association between asthma phenotype and microbiome signature
2 years
Determine whether microbiome signature can predict treatment response or resistence
2 years
Eligibility criteria
Inclusion Criteria: * Patients ≥18 years * Patients able to give informed consent * Patients who have been referred with possible asthma or have an established diagnosis of asthma Exclusion Criteria: * Patients \<18 years * Patients unable to give informed consent * Patients who are or intend to become pregnant during the study period * Other co-existent respiratory diagnosis e.g. bronchiectasis, COPD, Pulmonary fibrosis
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Once all collected, the available samples will be processed for microbiome and host transcriptome profiling. Blood samples will be processed for complete blood count, immunoglobulin E and aeroallergen sensitivity. In addition blood will be processed for host immune profiling. Background control, oral rinse, nasopharyngeal swab, exhaled breath condensate, induced sputum and stool samples will be processed for microbiome. EBC and induced sputum will also be processed for host immune profiling. From the bronchoscopy cohort, all collected samples will undergo microbiome analysis. We will also perform host immune profiling on BAL samples. Endobronchial brushes will be processed for host transcriptome analysis.'}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}
Updated at
2023-09-08

1 organization

1 product

1 indication

Indication
Asthma