Controlled exposure to a viral mimic for studying lung immune responses

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.