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).
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.
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.
Adult patients with physician-diagnosed asthma, recruited from outpatient and/or inpatient clinics at participating hospitals.
Cohort
Prospective
Not listed
Small airways function and Oscillometry
Improvement in small airways function as evaluated by the oscillometry measure R5-19 (in cmH2O/L/s) at 12 weeks compared to baseline in the whole study population
Pulmonary test function results and Questionnaires
Change in R5-19 (cmH2O/L/s, at 4 weeks), Change in FEF25-75% (% pred., at 4 and 12 weeks), Change in FEV1 (L, at 4 and 12 weeks), Change in residual volume (RV) (% pred., at 4 and 12 weeks), Change in total lung capacity (TLC) (% pred., at 4 and 12 weeks), Change in FeNO (ppb, at 4 and 12 weeks), Change in asthma control test (ACT) (at 4 and 12 weeks), Change in asthma quality of life (mini-AQLQ) (at 4 and 12 weeks)
Optional evaluation (at 52 weeks)
Change in R5-19 (at 4 weeks), Change in FEF25-75% (at 4 and 12 weeks), Change in FEV1 (at 4 and 12 weeks), Change in residual volume (RV) (at 4 and 12 weeks), Change in total lung capacity (TLC) (at 4 and 12 weeks), Change in FeNO (at 4 and 12 weeks), Change in asthma control test (ACT) (at 4 and 12 weeks), Change in asthma quality of life (mini-AQLQ) (at 4 and 12 weeks) Exacerbations (OCS courses, emergency department visits, hospitalizations) in the follow-up period and comparison to the exacerbation history in the previous year
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University Hospital, Ioannina
Lead sponsor
Attikon Hospital
Collaborator
424 General Military Hospital
Collaborator
George Papanicolaou Hospital
Collaborator
University Hospital of Patras
Collaborator
University Hospital, Alexandroupolis
Collaborator
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