Status:
RECRUITING
Lung Immune Challenge Study: Controlled Exposure to Inhaled Resiquimod (R848)
Lead Sponsor:
Akhilesh Jha
Collaborating Sponsors:
University of Cambridge
Conditions:
Innate Immunity
Mucosal Immunity
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
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 in...
Detailed Description
Background The initial immune response to respiratory viral infections is key to determining what kind of clinical outcome is experienced. The COVID-19 pandemic highlights the key importance of gainin...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06488118
Start Date
May 24 2024
End Date
July 1 2025
Last Update
July 10 2024
Active Locations (1)
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1
NIHR Cambridge Clinical Research Facility
Cambridge, Cambridgeshire, United Kingdom, CB2 0SL