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 @ 11:13 PM
Ignite Modification Date:
2025-12-24 @ 11:13 PM
NCT ID:
NCT02307669
Eligibility Criteria:
Inclusion Criteria:
* Must be willing to give voluntary informed consent
* Must have a clinical diagnosis of asthma supported by objective measures, one of the following by FEV1/FVC \<70% and FEV1 \<80% or - a 12% change in FEV1 following administration of a beta-agonist or spontaneously over 1 year period, a positive bronchial provocation test, or a 10% variability in PEF within a 7 day period.
* Must have a bronchodilator FEV1 \> 40% and \<80% in the past 1 year
* Current unstable asthma i.e. ACT score ≤ 19 at enrolment despite already being managed with GINA step 3-5 therapy.
* One or more courses of oral corticosteroids in the prior year, or a hospitalization or ED attendance with an asthma exacerbation in the last year
* Age 18 years or older at time of consent.
* Capable of understanding and complying with the requirements of the protocol, including the ability to attend for all required visits.
* Able and willing to take inhaled medication via a Diskus.
* In the opinion of the investigator suitable for use of a salmeterol/fluticasone Diskus inhaler or already using a salmeterol/fluticasone inhaler.
Exclusion Criteria:
* Have used any investigational product or device within 3 months of the enrolment visit.
* Have known previous sensitivity to Seretide (salmeterol/fluticasone).
* Have a known significant (in the opinion of the investigator) concurrent medical disease, pregnancy that might mean that the participant cannot complete the study.
* Be taking omalizumab or other biological agent used in the treatment of asthma
* Concurrent treatment with potent cytochrome P450 3A4 (CYP3A4) inhibitors; Ketoconazole and Ritonavir.
* Current smokers and ex-smokers with a greater than 20 pack year history of cigarette smoke
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02307669
Study Brief:
Protocol Section:
NCT02307669