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

Sponsor
University Hospital, Ioannina
Study ID
NCT07372521
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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).

Key Dates

First listed
Jan 28, 2026
Start date
Jan 19, 2026
Status verified
Jan 2026
Primary completion
Jun 30, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
130 participants (estimated)

Arms

  • Arm: Males and females out-patients aged ≥18 years with uncontrolled asthma on ICS/LABA treatment

Primary Outcome Measure

Small airways function and Oscillometry [ Time Frame: From January 2026 to June 2027 ]

Central Contacts

Find similar trials

Nationwide
Asthma trialsPulmonology trialsLung disease trials

Related Studies