Measuring Small-Airways Disease Improvement After Step-up to Extrafine TRIple or High-dose ICS/LA… (NCT07372521) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Measuring Small-Airways Disease Improvement After Step-up to Extrafine TRIple or High-dose ICS/LABA in Patients Uncontrolled on Medium Dose ICS/LABA eXploring T2 Inflammation
130 participantsStarted 2026-01-19
Plain-language summary
The goal of this observational study is to investigate the change in small airway function through the R5-R19 index in oscillometry at 12 weeks in adults with asthma.
The main question it aims to answer is: How can small airways dysfunction as evaluated by the oscillometry measure R5-19 be improved at 12 weeks, using 2 treatment arms (high-dose ICS regimen or medium dose efSITT)?
Researchers will compare the efficacy of either (1) high-dose ICS combinations (high-dose extrafine BDP/FF or high-dose efSITT BDP/FF/G) or (2) medium-dose efSITT (BDP/FF/G) to determine whether there is an improvement in small airways dysfunction and better asthma control in patients who are uncontrolled on medium-dose ICS/LABA.
Participants will take as drugs the Trimbow (BDP/FF/G) medium (100/6/10 μg) or high (200/6/10 μg) strengths or Foster (BDP/FF) high strength (200/6 μg); Visit the clinic three times with an one optional follow up visit, at the start (Visit 1: baseline), at 4 weeks (Visit 2), at 12 weeks (Visit 3) and the optional visit at 52 weeks (Visit 4).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Males and females out-patients aged ≥18 years providing written informed consent. \[Note: Females are eligible if they are of non-childbearing potential or, if they are of childbearing potential, using or are willing to use appropriate contraceptive measures.\]
* Physician-diagnosed asthma for at least 6 months
* Patients with uncontrolled asthma (ACT\<20 or ACQ-5\>1.5) on stable treatment with medium dose ICS/LABA for at least 12 weeks and with good adherence to treatment.
* Evidence of SAD as expressed by FEF25-75% \<60% in spirometry.
* Ability to be trained to use properly a pMDI inhaler (with or without spacer as per physician's judgement).
* Documented decision in the patient's medical file for the (high-dose ICS regimen or medium dose efSITT) before the patient gets informed about his/her potential participation in the study.
Exclusion Criteria:
* Age \<18 years
* Patients who have experienced a severe asthma exacerbation (i.e. receiving OCS for at least 3 days and/or antibiotics or need for hospitalisation) in the 4 weeks prior to the screening visit.
* Refusal or inability to give informed consent.
* Patients with COPD or other respiratory disease, e.g. bronchiectasis, cystic fibrosis, interstitial lung diseases or any other clinically or functionally significant lung disorder, cancer (except localized carcinomas), or other clinically significant comorbidities that may affect the outcomes measured.
* Long-term oxygen therapy at home.
* Pregna…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.