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:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-24 @ 10:35 PM
NCT ID:
NCT07272135
Eligibility Criteria:
Inclusion Criteria:
* Men or women
* Minimum 21 years old
* History of mild-to-moderate asthma for at least 6 months and controlled by an inhaled SABA, as required
* Otherwise healthy
* Ideally have participated in previous asthma studies
* No corticosteroid for whatever reason within 8 weeks of the start of dosing
* No other prescription medicine within 28 days (apart from a short acting beta-agonist (SABA) or contraceptives in women)
* No over-the-counter medicine within 7 days (apart from acetaminophen) before the start of dosing
* Negative screen for drugs of abuse; forced expiratory volume in 1 second (FEV1) more than or equal to 70% predicted
* Fractional exhaled nitric oxide (FeNO) more than or equal to 35 ppb
* 15% fall in FEV1 after inhaled mannitol (PD15)
* Non-smoker or past smoker (\<5 pack years)
* Substitution of subject's SABA inhaler with an anti-cholinergic inhaler, ipratropium bromide, for use as a reliever or rescue medication during a run-in period and during dosing with TR4 or placebo.
Exclusion Criteria:
* Positive test for hepatitis B \& C or HIV
* Drug or alcohol abuse
* Airway infection or asthma exacerbation in the last 4 weeks
* Current seasonal asthma
* History of emergency treatment of asthma
* Loss of more than 400 mL blood, or participation in other clinical trials of unlicensed medicines within the previous 3 months
* Consumption of grapefruit or herbal remedies within the past 7 days
* Objection by the subject's general practitioner (GP)
* Subjects who are sexually active and not using reliable contraception
* Women who are lactating, pregnant or plan to become pregnant during the study period
* Positive polymerase chain reaction (PCR) test for SARS-CoV-2 virus
* Subjects who have not received both doses of a COVID-19 vaccine.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT07272135
Study Brief:
Protocol Section:
NCT07272135