Using Multiomics to Define Mechanisms of Rhinovirus-induced Chronic Obstructive Pulmonary Disease… (NCT07112235) | Clinical Trial Compass
RecruitingNot Applicable
Using Multiomics to Define Mechanisms of Rhinovirus-induced Chronic Obstructive Pulmonary Disease Exacerbations to Develop Novel Therapies and Therapeutic Targets
United Kingdom50 participantsStarted 2025-10-08
Plain-language summary
The goal of this study is to examine exacerbations of chronic obstructive pulmonary disease (COPD) caused by a common cold virus called rhinovirus, to identify new treatments. Exacerbations are flare-ups of respiratory symptoms which are a major cause of ill health in people with COPD, and are most commonly caused by viruses.
The main questions the study aims to answer are:
* What processes in the body occur in response to rhinovirus infection, and do the differences between people with COPD and healthy volunteers explain why people with COPD develop more severe illness and exacerbations?
* Can treatments be identified that target these processes to reduce the severity and frequency of exacerbations in people with COPD?
The study will compare eligible participants with COPD to healthy volunteers, and will involve intentionally infecting each participant with rhinovirus in a controlled environment. They will undergo baseline investigations prior to infection including a first bronchoscopy. Post-infection each participant will undergo a range of tests, including a second bronchoscopy, to compare how processes in the body, and especially the lungs, differ between people who do and do not have COPD.
Who can participate
Age range
40 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria for COPD subjects
* Male or female sex
* Age ≥40 years and ≤75 years at the time of signing the consent form
* Medical history or clinical diagnosis of COPD
* Significant smoking history, defined as:
* Cumulative smoking history of at least 20 pack years
* Permitted to currently use, or have history of use of, e-cigarettes/vapes
* COPD spirometry criteria:
* Post bronchodilator FEV1 of \<80% and ≥50% predicted for age and height (equivalent to GOLD criteria stage 2 for 'Moderate' severity COPD9)
* Post-bronchodilator FEV1/FVC ratio \<0.7
* β-agonist reversibility: an improvement of less than 12% predicted FEV1 and less than 200mL after 200 micrograms of salbutamol or equivalent short acting beta-2 agonist bronchodilator.
* History of acute exacerbations of COPD as defined by the participant answering "yes" to the question: "do your COPD symptoms get noticeably worse when you catch a cold?"
* Clinically stable with no COPD exacerbations within 8 weeks prior to enrolment
* Permitted to take short and long-acting bronchodilators including beta agonists and muscarinic antagonist inhalers
* Co-morbidity criteria:
* Permitted to have a past medical history of asthma, allergic rhinitis and seasonal rhinitis, but not currently active within 8 weeks prior to enrolment
* Absence of current or previous history of significant respiratory disease, other than COPD, asthma and allergic rhinitis
* Permitted to have a positive skin test for atopy
Inclusio…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Lower Respiratory Symptom Score (LRSS)
Timeframe: Participants will record this score daily, from the date of the baseline visit to the final day of their involvement in the study (expected to be day 42).