This is a 6-month Observational Study. Patients Included Will be Those Referred With a Possible Diagnosis or an Established Diagnosis of Asthma. It Will Look at the Association of the Asthma Microbiome and Disease Characteristics, Severity and Treatment Response.

NCT06028204 | Unknown DMC FDA Drug

• 1 other identifier: 23.29
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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. 1.Evaluate the influence of the microbiome on asthma phenotypes
2. 2.Evaluate the influence of the microbiome on respiratory physiological change
3. 3.Evaluate the effect of asthma treatment on the microbiome and the host response

Conditions

Asthma

Outcome Measures

Primary Outcomes (3)

• Describe microbiome signature across the spectrum of asthma severity

  We expect an increasingly dysbiotic signature in the respiratory microbiome of patients with severe asthma.

  2 years

• Establish if there is any association between asthma phenotype and microbiome signature

  We expect to see a correlation between dysbiosis in the respiratory microbiome and changes in symptom control and physiological parameters.

  2 years

• Determine whether microbiome signature can predict treatment response or resistence

  We expect to identify a microbial signature in the respiratory microbiome associated with treatment response, to both biological therapy as well as inhaled corticosteroids.

  2 years

Study Arms (2)

Biologic Naïve Group

This will aim to include 50 patients who have been referred with possible asthma or have a diagnosis of asthma, and are established on treatment in the form of bronchodilators and/or inhaled corticosteroids who are not candidates for biologic therapy at present

Biologic Group

This will aim to include 10 patients who have been referred with an established diagnosis of asthma and are on treatment in the form of bronchodilators and/or inhaled corticosteroids and have been selected as suitable candidates for commencing biologic therapy.

Drug: Biologic Agent

Interventions

Biologic Agent DRUG

Biologic group will have biological agent commenced if considered necessary as part of routine care.

Biologic Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient referred with a possible diagnosis of asthma or established diagnosis of asthma to hospital or the Respiratory Outpatient Department

You may qualify if:

• Patients ≥18 years
• Patients able to give informed consent
• Patients who have been referred with possible asthma or have an established diagnosis of asthma

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal College of Surgeons, Ireland: lead
• The Charitable Infirmary Charitable Trust: collaborator
• New York University: collaborator

Biospecimen

Retention: SAMPLES WITHOUT DNA

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.

MeSH Terms

Conditions

Asthma

Interventions

Biological Factors

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Margaret Gleeson, MB BCh BAO

CONTACT

+353871712690; margaretgleeson@rcsi.ie

Imran Sulaiman, MB BCh BAO

CONTACT

+353863840469; imransulaiman@rcsi.ie

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: September 8, 2023
• Study Start: October 1, 2023
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: September 8, 2023

Record last verified: 2023-08