Lung Immune Challenge Study: Controlled Exposure to Inhaled Resiquimod (R848)

Launched by AKHILESH JHA · Jun 28, 2024

Keywords

ClinConnect Summary

The Lung Immune Challenge Study is researching how our immune system responds to respiratory viral infections, especially in people with asthma or other airway diseases. The study uses a safe substance called Resiquimod (R848) that mimics the effects of a viral infection without causing an actual infection. Participants will inhale a fine mist of this substance to help researchers understand how it affects inflammation in the lungs. By studying this, the researchers hope to develop better treatments for lung inflammation that can occur after viral infections.

To join the study, participants need to be between 18 and 60 years old and willing to provide informed consent. They can be healthy volunteers or have mild to moderate asthma that is well-controlled. Participants will undergo a simple inhalation procedure, and researchers will collect samples of blood and mucus to check for inflammation and how well they tolerate the treatment. It’s important to note that people with recent respiratory infections, certain medical conditions, or who are pregnant cannot participate. Overall, this study aims to enhance our understanding of immune responses in the lungs, which could lead to improved care for individuals with respiratory issues.

Gender

ALL

Eligibility 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.