Actively Recruiting
Lung Immune Challenge Study: Controlled Exposure to Inhaled Resiquimod (R848)
Led by Akhilesh Jha · Updated on 2024-07-10
36
Participants Needed
1
Research Sites
57 weeks
Total Duration
On this page
Sponsors
A
Akhilesh Jha
Lead Sponsor
U
University of Cambridge
Collaborating Sponsor
AI-Summary
What this Trial Is About
Respiratory viral infections can be a cause of significant illness, particularly in vulnerable individuals as seen in the COVID-19 pandemic. An underactive or overactive immune response can lead to ineffective resolution of inflammation after an infection, especially in people with airway diseases such as asthma. A better understanding of immune responses to infection that does not rely on cell or animal models is crucial to help develop better treatments for lung inflammation. An established method of studying inflammation in humans is through careful and controlled exposure (or "challenge") with a mimic of a virus to simulate an infection in a similar manner to that of a virus, but with the advantage of not causing an infection. The investigators have already developed a well-tolerated mimic of human viral infection using a sterile substance called Resiquimod (or R848). Since it does not contain living organisms there is no possibility of being infected. This has been used previously as a nasal spray to cause a mild short-lived inflammation that mimics a mild cold. This has been used safely in a range of people of different ages including those who have asthma. There are differences however in how the nose and lungs respond to viral infections. This is particularly true in those with airway diseases such as asthma, who have cells in the airways of their lungs that respond in a different way to inflammatory triggers (such as viruses). The current study aims to build on previous research by developing a new approach of studying inflammation in the lungs using a small volume of Resiquimod. This will be done by gently inhaling a fine mist through a mouthpiece into the lungs. Blood and phlegm samples would then be collected to assess inflammation and how well people tolerate the procedure.
CONDITIONS
Official Title
Lung Immune Challenge Study: Controlled Exposure to Inhaled Resiquimod (R848)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 use effective contraception during the study
- Clinically acceptable laboratory measurements and ECG at enrolment
- Ability to expectorate sputum
- No clinical history of asthma and normal baseline spirometry (FEV1/FVC ratio z-score above lower limit of normal) for healthy volunteers
- Physician-diagnosed mild to moderate asthma with ACQ-5 score ≤1.5 for volunteers with asthma
- Allowed inhaled corticosteroids (ICS), long-acting beta agonist (LABA) and long-acting muscarinic antagonists (LAMA) use in asthma volunteers
- Pre-bronchodilator FEV1 ≥70% predicted
- Evidence of bronchial hyperreactivity by bronchodilator reversibility, positive methacholine challenge, or positive challenge test as per policy
You will not qualify if you...
- 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 that may put participants at risk or influence study results
- Participation in another investigational study in the past 12 weeks
- Newly prescribed medications including corticosteroids in the 4 weeks before first study dose except mild analgesia, vitamins, and supplements
- Smoking tobacco or vaping products in previous 6 months
- Smoking history of more than 5 pack years
AI-Screening
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Trial Site Locations
Total: 1 location
1
NIHR Cambridge Clinical Research Facility
Cambridge, Cambridgeshire, United Kingdom, CB2 0SL
Actively Recruiting
Research Team
A
Akhilesh Jha, MBBS; MRCP; PhD
CONTACT
J
Jade Joseph, BSc; MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
8
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