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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

NCT07372521

Not Yet RecruitingN/A

Sponsor: University Hospital, Ioannina

Conditions: Asthma

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).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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.
* Pregnancy or lactation or planned pregnancy.
* Patients with a history of hypersensitivity or contraindications to any of the components of the study drug.
* Participation in interventional study within 30 days prior to enrolment or at least two half-life times of an investigational drug.
* Patient inability or incompliance to follow physician's instructions concerning treatment or study visits or unreliability, according to the physician evaluation.