Airway Remodeling and Rhinovirus in Asthmatics

Launched by UNIVERSITY OF CALGARY · Mar 7, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating how the common cold virus, known as human rhinovirus, affects people with asthma. Researchers want to understand why this virus can make asthma symptoms worse and whether it causes lasting changes in the airways, a process known as airway remodeling. By comparing participants with mild to moderate asthma to healthy individuals, the study aims to measure levels of inflammation and other changes in the airways after a rhinovirus infection. This research could lead to better treatments for asthma triggered by colds.

To participate in the study, individuals with asthma must be between 18 and 65 years old and have a history of asthma symptoms. They should also show some evidence of lung function issues but have their asthma generally under control. Healthy participants who do not have asthma and meet certain health criteria are also welcome. Participants will have the opportunity to undergo tests and monitoring to help researchers gain insights into how the virus interacts with the airways. It's important for potential participants to know that they need to be in good health overall and not be currently sick or taking certain medications.

Gender

ALL

Eligibility 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.