Investigating how rhinovirus affects asthma and airway changes
Comparison of Airway Remodeling Mediators Following Experimental Human Rhinovirus Infection in Subjects With Mild to Moderate Asthma and Healthy, Non-asthmatic Control Subjects
This study looks at how rhinovirus infections affect asthma symptoms and airway changes in people with mild to moderate allergic asthma to see if it can help improve their treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Calgary Academic / other |
| Locations | 1 site (Calgary, Alberta) |
| Trial ID | NCT05775952 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the relationship between human rhinovirus infections and asthma symptoms, particularly focusing on airway remodeling in asthmatic patients. Researchers will examine how rhinovirus impacts epithelial cell biology and whether these infections lead to long-term structural changes in the airways. The study will involve participants with mild to moderate allergic asthma, assessing their respiratory function and response to the virus. By understanding these mechanisms, the study seeks to improve treatment strategies for asthma exacerbated by viral infections.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 65 with mild to moderate allergic asthma and evidence of airway hyperresponsiveness.
Not a fit: Patients with severe asthma or those not meeting the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better management and treatment options for asthma patients experiencing exacerbations due to rhinovirus infections.
How similar studies have performed: While there have been studies on rhinovirus and asthma, this specific investigation into airway remodeling in asthmatics is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Asthma Cohort Inclusion Criteria: * Male or female volunteers with intermittent or persistent mild to moderate allergic asthma, as defined by GINA guidelines. * Between ≥18 and ≤ 65 years of age * Objective evidence of variable airflow limitation (≥12% and at least 200mL post-bronchodilator reversibility from baseline) and airway hyperresponsiveness (PC20 methacholine \<16mg/mL) at screening or within past 5 years * Spirometry at baseline shows FEV1 ≥ 60% of predicted; FEV1/FVC ≥ 0.40 * Atopic, as evidenced by positive skin prick tests to ≥1 common aero-allergen, where positive is defined by a wheal of ≥2 mm greater than the negative control * Not be exposed to sensitizing seasonal allergens for at least 4 weeks before visit 2 * Asthma symptoms controlled by either inhaled beta 2-agonists alone, or by low or moderate dose (≤800 μg of budesonide or equivalent per day) inhaled corticosteroid (ICS) administered either as monotherapy or in a fixed-dose combination with a long-acting beta 2-agonist (LABA) * Be a non-smoker for ≥1 year and have a lifetime ≤ 10 pack-year smoking history of smoking * In good general health (other than asthma) without clinically significant medical history of other comorbidities, and a BMI of ≤ 35 kg/m2. Healthy, Non-asthmatic Cohort Inclusion Criteria: * Male or female volunteers in good general health, without clinically significant medical history and a BMI of ≤ 35 kg/m2 * Between ≥18 and ≤ 65 years of age * Non-asthmatic, as defined by history and normal spirometry (FEV1 ≥80% predicted; FEV1/FVC ≥ 0.75) * Normal airway responsiveness (PC20 methacholine not detected at, or less than, 16 mg/mL) * Non-atopic, as determined by skin prick tests to common aero-allergens, where a positive test is defined as a wheal of ≥2 mm greater than the negative control. * Be a non-smoker for ≥1 year and have a lifetime ≤ 10 pack-year smoking history of smoking * Willing to participate in study and be able to provide written consent prior to starting the study. Exclusion Criteria (both cohorts): * Presence of neutralizing antibodies to HRV-39 * Current pregnancy or positive urine pregnancy test at screening * Use of any of the following medications: antihistamines, leukotriene antagonists, inhaled anticholinergics, non-steroidal anti-inflammatories, antibiotics, and over the counter 'cold' and influenza remedies, in preceding 4 weeks prior to visit 2. * Current acute or chronic illness (including infection) or recent recovery (within 4 weeks of visit 3) from acute illness which could, in the opinion of the Investigator, alter inflammatory responses (e.g., flu, cold or other respiratory infection, etc.). * Autoimmune disease or immunodeficiency * Any other significant concomitant medical issue, or findings on physical examination or medical history that, in the opinion of the study physician, may pose additional risks from participation in the study (including undergoing bronchoscopy), or which may impact the quality or interpretation of the data obtained from the study. * Inability or unwillingness of a potentially eligible study participant to give written informed consent. * Unable or unwilling to adhere to protocol-defined study visit schedule and/or other protocol requirements.
Where this trial is running
Calgary, Alberta
- University of Calgary — Calgary, Alberta, Canada (Recruiting)
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.