Characterizing asthma severity through gene expression analysis
Phenotyping Disease Severity in Asthma: Molecular Investigations of Corticosteroid
University of Calgary · NCT05078021
This study is trying to see how gene activity in the lungs of asthma patients with different severity levels responds to treatment compared to healthy individuals.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | University of Calgary (other) |
| Drugs / interventions | prednisone |
| Locations | 1 site (Calgary, Alberta) |
| Trial ID | NCT05078021 on ClinicalTrials.gov |
What this trial studies
This observational study aims to analyze and compare the molecular gene expression profiles in endobronchial biopsies and bronchial washings from asthma patients with varying severity levels who are on maintenance inhaled corticosteroid treatment, alongside healthy controls. By recruiting 60 participants, including 15 each from mild, moderate, and severe asthma categories as defined by GINA guidelines, the study will produce transcriptomic profiles associated with asthma severity. Additionally, the study will culture epithelial cells to investigate differences in corticosteroid responses between the groups, potentially identifying intrinsic differences in treatment efficacy.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-60 with a confirmed diagnosis of asthma and stable inhaled therapy for at least 12 weeks.
Not a fit: Patients who are current smokers or have a significant smoking history may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding of asthma severity and more tailored treatment approaches for patients.
How similar studies have performed: While there have been studies on gene expression in blood, this approach focusing on airway transcriptomics in asthma severity is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-60 * Confirmed diagnosis of asthma by CTS criteria * No contraindication to bronchoscopy * No treatment with azithromycin * No oral corticosteroid in the 4 weeks prior * No participation in another drug study in the 4 weeks prior * On stable doses of asthma inhaled therapies for 12 weeks prior to bronchoscopy * FEV1 \>80% Exclusion Criteria: * Current smokers (within past year) * Subjects with ≥10 pack-year lifetime smoking history * History of asthma exacerbation (requiring oral prednisone) in the 4 weeks prior to study entry
Where this trial is running
Calgary, Alberta
- University of Calgary — Calgary, Alberta, Canada (RECRUITING)
Study contacts
- Study coordinator: Brianne S Philipenko, MD
- Email: brianne.philipenko@gmail.com
- Phone: 3063806777
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Asthma