Actively Recruiting
Airway Remodeling and Rhinovirus in Asthmatics
Led by University of Calgary · Updated on 2024-05-09
24
Participants Needed
1
Research Sites
695 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Human rhinovirus is also called the "common cold virus" because it causes at least half of all of the common colds experienced each year. In patients with asthma, getting a rhinovirus infection can cause worsening of asthma symptoms. Although these symptoms are well known, researchers do not fully understand how the virus worsens these asthma symptoms, nor do they really know whether virus infection causes longer term structural changes (often referred to as airway remodeling) in the airways. This study plans to address and answer these questions. Doing so will provide the researchers with a better understanding of how to treat the worsening of asthma that are caused by human rhinovirus infections. The epithelial cell is the cell that lines the surface of your airways from your nose down to your lungs, and is also the cell type that gets infected by rhinovirus. At present, it is thought that the virus causes symptoms by changing epithelial cell biology in a way that causes airway inflammation. Some of these inflammatory molecules are also thought to cause scarring (remodeling) of the airways, which over time, may lead to a loss of lung function. In order to examine how the virus causes inflammation, many earlier studies have used experimental infection with the virus and have measured various markers of inflammation. The purpose of this study is to compare the levels of inflammatory and remodeling products in the airways of study participants with mild to moderate asthma and healthy, non-asthmatic subjects after infection with rhinovirus (the common cold virus).
CONDITIONS
Official Title
Airway Remodeling and Rhinovirus in Asthmatics
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female volunteers aged 18 to 65 years with mild to moderate allergic asthma as defined by GINA guidelines
- Evidence of variable airflow limitation with at least 12% and 200mL reversibility post-bronchodilator and airway hyperresponsiveness (PC20 methacholine <16mg/mL) at screening or within past 5 years
- Baseline spirometry with FEV1 ≥ 60% predicted and FEV1/FVC ≥ 0.40
- Positive skin prick test to at least one common aero-allergen with wheal ≥ 2 mm larger than negative control
- No exposure to sensitizing seasonal allergens for at least 4 weeks before visit 2
- Asthma symptoms controlled by inhaled beta 2-agonists alone or low/moderate dose inhaled corticosteroids (≤800 µg budesonide or equivalent per day) with or without long-acting beta 2-agonist
- Non-smoker for at least 1 year with lifetime smoking ≤ 10 pack-years
- Good general health aside from asthma with BMI ≤ 35 kg/m2
- Male or female volunteers aged 18 to 65 years in good general health without asthma
- Normal spirometry with FEV1 ≥ 80% predicted and FEV1/FVC ≥ 0.75
- Normal airway responsiveness with PC20 methacholine not detected or >16 mg/mL
- Negative skin prick test to common aero-allergens
- Non-smoker for at least 1 year with lifetime smoking ≤ 10 pack-years
- Willing and able to provide written consent
You will not qualify if you...
- Presence of neutralizing antibodies to HRV-39
- Current pregnancy or positive urine pregnancy test at screening
- Use of antihistamines, leukotriene antagonists, inhaled anticholinergics, NSAIDs, antibiotics, or cold and influenza remedies within 4 weeks before visit 2
- Current acute or chronic illness including infection, or recent recovery from acute illness within 4 weeks of visit 3 that might affect inflammatory responses
- Autoimmune disease or immunodeficiency
- Any significant medical condition or findings that might increase risk or affect study data interpretation
- Inability or unwillingness to provide written informed consent
- Unable or unwilling to follow the study visit schedule or protocol requirements
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Calgary
Calgary, Alberta, Canada, T2N4Z6
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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