Nasal immune challenge using a spray to mimic viral infection
Nasal Immune Challenge Study
This study is testing a nasal spray that mimics a viral infection to see how it affects the immune response in healthy people, which could help us understand and treat respiratory issues like asthma and allergies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cambridge University Hospitals NHS Foundation Trust Academic / other |
| Locations | 1 site (Cambridge, Cambridgeshire) |
| Trial ID | NCT06021002 on ClinicalTrials.gov |
What this trial studies
This study investigates the immune response in the nasal passages by using a nasal spray containing Resiquimod, a sterile substance that simulates a viral infection without causing disease. The aim is to better understand innate immune responses in the respiratory tract, particularly in relation to conditions like asthma and nasal allergies. Participants will be monitored for their immune responses to this treatment, which could provide insights into new therapeutic options for respiratory diseases. The study focuses on healthy volunteers without a history of allergic conditions to ensure accurate results.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 18 and above with no history of allergic rhinitis, asthma, or eczema.
Not a fit: Patients with existing respiratory conditions or allergies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and treatment options for respiratory diseases exacerbated by viral infections.
How similar studies have performed: While the approach of using a nasal spray to simulate viral infection is innovative, similar studies have shown promise in understanding immune responses, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participant is willing and able to give informed consent for participation in the study. * Male or female aged 18 years and above * Able (in the Investigators opinion) and willing to comply with all study requirements. * Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of 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 * Participant has clinically acceptable laboratory and ECG at enrolment. * Negative lateral flow or polymerase chain reaction (PCR) test for SARS-CoV-2 * For healthy volunteers: * No clinical history of allergic rhinitis, asthma or eczema * Negative skin prick tests or specific IgE response to a panel of common aeroallergens: cat, dog, grass pollen, tree pollen, house dust mite, fungal spores * Normal blood eosinophil count (\< 300 cells/μL) * Normal baseline forced expiratory volume (FEV1) i.e. ≥80% * For volunteers with allergic rhinitis with or without asthma: * A clinical history of allergic rhinitis symptoms (sneezing, runny or itchy nose) in response to aeroallergens * At least one positive skin-prick test or specific IgE response to a panel of common aeroallergens: cat, dog, grass pollen, tree pollen, house dust mite, fungal spores * Pre-bronchodilator FEV1 ≥50% predicted * Participants are permitted to have physician-diagnosed mild to moderate asthma which is not poorly controlled as evidenced by an Asthma Control Questionnaire (ACQ-5) score of ≤1.5. * If they have asthma, they are permitted to be on inhaled corticosteroid (ICS) and a long-acting beta agonist (LABA), but no other controller medication. * Have had no other courses of medication including nasal and systemic corticosteroids, whether prescribed or over-the-counter, in the four weeks before first study dose other than mild analgesia, vitamins and mineral supplements or, for females, oral contraceptives. Exclusion Criteria: * Recent infections in past 14 days before screening: especially upper respiratory tract illnesses (including colds and influenza), sore throats, sinusitis, infective conjunctivitis. * Lower respiratory tract infection in past 28 days * Nasal anatomical defects, precluding use of nasal sampling techniques * The participant may not enter the study if any of the following apply: * Female participants who are pregnant, lactating or planning pregnancy during the study. * Respiratory diseases (other than hay fever or asthma where specified) * Significant medical history of hepatic, cardiovascular, gastrointestinal, renal, endocrine, infective, haematological, autoimmune, metabolic, rheumatological, neurological, dermatological or neoplastic conditions * Extreme obesity (BMI \>40) * Depression and psychiatric disorders * 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 * Smoking in previous 6 months
Where this trial is running
Cambridge, Cambridgeshire
- Cambridge University Hospitals NHS Foundation Trust — Cambridge, Cambridgeshire, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Akhilesh Jha, MBBS, PhD
- Email: akhilesh.jha@nhs.net
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.