An exploratory study to establish a rhinovirus challenge model

• Research type

  Research Study

• Full title

  An exploratory study to establish a rhinovirus challenge model in asthma patients

• IRAS ID

  133001

• Contact name

  David Rogers

• Contact email

  drogers@meu.org.uk

• Sponsor organisation

  The Medicines Evaluation Unit (MEU)Ltd. (Investigator led study)

• Research summary

  Summary of Research
  This is an exploratory study to assess the effect of Rhinovirus (RV) challenge in patients with asthma. The study will be conducted in two phases: a pilot phase comprising the RV challenge only followed by a full recruitment phase comprising two cohorts, Cohort A which will consist of the RV challenge only and Cohort B in which a RV challenge combined with an allergen challenge will be performed. The purpose of the pilot phase is to ensure that the rhinovirus challenge in our hands leads to the expected symptoms and change in lung function in patients with asthma, before embarking on the main phase which involves more complexity including bronchoscopies. Cohort A will consist of asthma patients and healthy volunteers and Cohort B will be asthma patient only. The study will review lung function, symptoms and biological changes in the airways as well as safety. The best model will be used in future studies investigating the efficacy of novel investigational asthmatic drugs. We will also evaluate whether the allergic/eosinophilic phenotype has a different response to RV challenge

  Summary of Results
  Rhinovirus—the virus that causes the common cold—is one of the main triggers of asthma flare‑ups. To better understand what happens inside the body during one of these virus‑induced asthma attacks, researchers deliberately exposed 11 people with moderate asthma to rhinovirus in a controlled clinical setting. All participants were already taking inhaled corticosteroids, which are standard asthma treatments.
  After infection, the participants experienced more cold symptoms and poorer asthma control within a week. Samples taken from their noses and lungs before and after infection showed that the body quickly activated its antiviral defenses. This included increased levels of several interferons—important proteins that help fight viruses—and other related immune signals.
  At the same time, the infection also boosted “type 2 inflammation,” a form of immune activity commonly linked to asthma. Proteins such as IL‑4, IL‑5, and IL‑13 increased, and in the lung samples, the levels of two epithelial‑derived proteins (IL‑25 and IL‑33) strongly matched the rise in these type 2 inflammatory markers. This suggests that the airway lining itself may help drive inflammation during a cold-triggered asthma flare.
  Overall, the study shows how a controlled rhinovirus infection affects immune responses in the noses and lungs of asthma patients who are already using inhaled steroids. The specific markers identified in the study could be useful tools for testing how new asthma treatments work.
  

• REC name

  North West - Preston Research Ethics Committee

• REC reference

  14/NW/0121

• Date of REC Opinion

  7 Mar 2014

• REC opinion

  Favourable Opinion