Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2025-12-25 @ 4:54 AM
NCT ID:
NCT06488118
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT06488118
Study Brief:
Protocol Section:
NCT06488118