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A Phase IIa, double-blind, randomized, placebo-controlled trial in participants with asthma to evaluate the impact of intranasal ETH47 on the development of lower respiratory tract symptoms following rhinovirus challenge - IHKB Study
Safe People
Organisation name
Imperial College London
Organisation sector
Academic Institute
Applicant name(s)
Oliver O’Connor
Funders/ Sponsors
Clinical Sponsor is not required
DEA accredited researcher?
Unknown
Sub-licence arrangements (if any)?
Yes
Safe Projects
Project ID
NIBDAPC_2025_0054
Lay summary
This study is testing a new treatment, called ETH47, to see if it can help prevent asthma flare-ups (exacerbations) triggered by viral infections, especially respiratory viruses like the common cold (rhinovirus). ETH47 is an experimental drug based on mRNA technology (whichworks by delivering synthetic messenger RNA into cells, which instructs them to produce specific proteins that help prevent or treat disease), which is designed to boost the body's immune response against viruses. Asthma exacerbations are often caused by respiratory viruses, and these exacerbations can make asthma worse, leading to more health problems and even death. Currently, there are no specific antiviral drugs for these viruses. Early treatment with antiviral medications could help lessen the severity of viral infections and prevent asthma flare-ups, which would help protect lung health. In this trial, researchers will test if ETH47 can help prevent exacerbations caused by rhinovirus in people with asthma. To join the study, participants must meet certain criteria. People who already have antibodies to the virus (meaning they’ve been exposed to it recently) won’t be included. The study will last for up to 9 weeks and will require participants to visit the clinic 16 times. Participants will either receive ETH47 or a placebo an inactive substance , starting the day before they are exposed to the virus. Before the infection, doctors will test their lung function, perform allergy skin tests, and do chest X-rays to confirm they have asthma. Throughout the study, participants aged between 18 – 65 will give samples like blood, nasal secretions, and breath samples. These will help doctors measure how the body responds to the treatment and to the virus. Researchers will also track participants’ asthma symptoms and lung function to see if ETH47 helps reduce exacerbations and improves overall asthma control. At the end of the study, the goal is to see if ETH47 can reduce asthma exacerbations and improve lung health for people with diagnosed asthma.
Public benefit statement
This research is important because viral infections, particularly those caused by rhinovirus (which is the primary cause of the common cold), significantly impact people with asthma. In people with asthma, viral infections like rhinovirus can cause sudden worsening of symptoms, known as exacerbations. These exacerbations are one of the main reasons patients with asthma end up in the hospital, and experience a reduced quality of life. Studies show that around two thirds of asthma exacerbations are caused by respiratory viral infections, with the majority of these being caused by rhinovirus. These viral exacerbations can lead to further loss of lung function. Even though there are treatments available for asthma, such as bronchodilators (which help open the airways), inhaled corticosteroids (which reduce inflammation), and antibiotics (which fight bacterial infections), these treatments are not fully effective for managing exacerbations caused by viruses and often come with significant side effects. This study suggests that developing a treatment specifically aimed at stopping rhinovirus could significantly improve outcomes for asthma patients. The idea is that if an anti-rhinovirus treatment is given early during an infection, it could prevent or limit the virus from replicating and spreading. This would, in turn, reduce the severity and duration of the exacerbation. The potential benefits of such a treatment include fewer exacerbations, less need for hospital visits, and better long-term health for asthma patients. By reducing the frequency and severity of exacerbations, this approach could not only improve the day-to-day lives of asthma patients but also help lower healthcare costs by reducing hospitalizations and the need for intensive treatments.
Request category type
Public Health Research
Other approval committees
Latest approval date
03/12/2025
Safe Data
Dataset(s) name
N/A - this is a consent to contact IHKB study; no data is being made available
Data sensitivity level
De-Personalised
Common Law Duty of Confidentiality
Not applicable
National data opt-out applied?
Not applicable
Request frequency
One-off
Safe Setting
Access type
TRE