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 @ 2:06 AM
Ignite Modification Date:
2025-12-25 @ 2:06 AM
NCT ID:
NCT04503460
Eligibility Criteria:
INCLUSION CRITERIA
* Age \> 18 years
* A doctor's diagnosis of asthma (mild in severity)
* No current regular asthma treatment or regular asthma treatment in the preceding 6 weeks; only a history of using short-acting bronchodilator inhalers on demand is allowed
* Pre-bronchodilator FEV1 value \> 70% of the predicted value
EXCLUSION CRITERIA
* History or evidence of chronic respiratory disease other than asthma
* History or evidence of other disease, blood test results outside the normal reference range or medication use that would impair the ability of participants to safely undertake the study or the ability of researchers to interpret the study results; this includes, but is not limited to, the use of anticoagulants (e.g. warfarin), adenosine diphosphate (ADP) receptor inhibitors (e.g. clopidogrel), antiretroviral therapy (due to the potential for interaction with fluticasone), certain antifungal agents (due to the potential for interaction with fluticasone) and beta-blockers
* Current use or use in the last 6 weeks of systemic or nasal topical steroids, inhaled corticosteroids or systemic immunosuppressants
* Platelet count \< 150 x 109/L or international normalised ratio (INR) \> 1.5
* History of smoking \> 5 pack years, current smoker or history of smoking in the last 4 weeks
* Current vaping or history of vaping in the last 4 weeks
* Current illicit drug use/abuse
* Abnormal chest x-ray appearance
* Signs or symptoms of upper respiratory tract infection or lower respiratory tract infection in the preceding 6 weeks
* Cardiac conduction abnormalities on electrocardiogram (ECG)
* Current pregnancy or planning to become pregnant during the study period
* Breastfeeding during the study period
* Inability to provide informed consent to participate in the study
* Current involvement in any other clinical research studies involving medicinal products or devices; or involvement in clinical research studies involving medicinal products within the last 30 days or within 5 half-lives of the medicinal product (whichever is longer)
* Inability to speak English or inability to understand verbal or written English
* Inability to attend hospital for all scheduled study visits
* Hypersensitivity to any of the investigational medicinal products (IMPs) or their excipients
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04503460
Study Brief:
Protocol Section:
NCT04503460