Controlled exposure to a viral mimic for studying lung immune responses
Lung Immune Challenge Study Controlled Exposure to Inhaled Resiquimod (R848) to Study Mechanisms of Inflammation
This study tests how people with asthma and healthy volunteers respond to a safe viral mimic to help understand and improve treatments for lung inflammation and asthma.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Cambridge University Hospitals NHS Foundation Trust Academic / other |
| Locations | 1 site (Cambridge, Cambridgeshire) |
| Trial ID | NCT06488118 on ClinicalTrials.gov |
What this trial studies
This study investigates the immune response to respiratory viral infections by using a controlled exposure to a non-infectious mimic called Resiquimod (R848). It aims to better understand how individuals, particularly those with asthma, respond to such infections without the risks associated with live viral exposure. Participants will be monitored for their immune responses, which could lead to improved treatments for lung inflammation and asthma. The study focuses on both healthy volunteers and those with mild to moderate asthma to assess differences in immune reactions.
Who should consider this trial
Good fit: Ideal candidates include healthy adults aged 18-60 and individuals with mild to moderate asthma who are well-controlled.
Not a fit: Patients with poorly controlled asthma or significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and treatment options for patients with asthma and other respiratory conditions.
How similar studies have performed: Previous studies using similar controlled exposure methods have shown promise in understanding immune responses, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female aged between 18 and 60 years. * Willing and able to give informed consent for participation in the study. * Female participants of child-bearing potential and male participants whose partner is of child-bearing potential must be willing to ensure that they or their partner use effective contraception during the study. * Clinically acceptable laboratory measurements and ECG at enrolment. * Ability to expectorate sputum. * Optional additional swab for SARS-CoV-2 testing will be collected from participants if required by local or/and national health and safety policies at the time of sampling. For healthy volunteers: * No clinical history of asthma * Normal baseline spirometry i.e. FEV1/Forced Vital Capacity (FVC) ratio z-score greater than the lower limit of normal. For volunteers with asthma: * Physician-diagnosed mild to moderate asthma which is not poorly controlled as evidenced by an Asthma Control Questionnaire (ACQ-5) score of ≤1.5. * They are permitted to be on inhaled corticosteroids (ICS), long-acting beta agonist (LABA) and long-acting muscarinic antagonists (LAMA). * Pre-bronchodilator FEV1 ≥70% predicted. * Evidence of bronchial hyperreactivity as evidenced by either (i) Bronchodilator reversibility (increase FEV1 ≥12% and 200 mL); (ii) Positive methacholine challenge (PC20 \< 8mg/ml), or (iii) Positive challenge test as per current CUH policy. Exclusion Criteria: * Upper respiratory tract infection in preceding 14 days. * Lower respiratory tract infection in preceding 28 days. * Female participants who are pregnant, lactating or planning pregnancy. * Respiratory diseases (other than asthma where specified). * Significant extrapulmonary medical conditions. * Extreme obesity (BMI \>40). * Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study. * Participants who have participated in another research study involving an investigational product in the past 12 weeks. * No newly prescribed courses of medication including corticosteroids in the four weeks before first study dose other than mild analgesia, vitamins, and supplements. * Smoking tobacco or vaping products in previous 6 months. * Smoking history of \>5 pack years.
Where this trial is running
Cambridge, Cambridgeshire
- NIHR Cambridge Clinical Research Facility — Cambridge, Cambridgeshire, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Akhilesh Jha, MBBS; MRCP; PhD
- Email: cuh.lungchallenge@nhs.net
- Phone: +44 01223254642
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.