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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 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2023-09-08

No results posted yet for this study

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. 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

Conditions

Interventions

DRUG

Biologic Agent

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

Sponsors & Collaborators

  • The Charitable Infirmary Charitable Trust

    collaborator UNKNOWN

  • New York University

    collaborator OTHER

  • Royal College of Surgeons, Ireland

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-31
Primary Completion
2025-07-31
Completion
2025-07-31
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06028204 on ClinicalTrials.gov