An observational study in Asthma, sponsored by University Hospital, Ioannina. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-03.
Sponsored by University Hospital, Ioannina · Observational
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).
All data related to the study will be recorded for each participating patient by the investigator in a separate, specially designed Case Report Form (CRF) at the start of the study. The CRF pages are specifically designed to capture the information required by the study protocol, and the investigator will enter these data into the corresponding fields, ensuring consistency with the information documented in the patient's medical record.
All patients who sign the informed consent to participate in the study will be assigned a unique 5-digit identification number in the format of XX-XXX (first two digits represent the centre number and the last 3 digits the patient number), which will be recorded on all relevant study documents (CRF etc.). The patient's initials and full date of birth will not be recorded in the CRF to protect personal data, except in cases specifically permitted under the General Data Protection Regulation (GDPR).
eCRFs will be periodically reviewed by the principal investigator to minimize missing values. When NaN entries cannot be avoided, the amount, pattern, and assumed mechanism of missingness (missing completely at random, missing at random, or missing not at random) will be evaluated to determine the most appropriate statistical approach. Imputation methods may include mean or median imputation, random sample imputation, or multiple imputation, as appropriate.
4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.
This study's planned enrollment of 130 is below the median of 158 across 1,250 observational studies indexed under Asthma.
Browse Asthma studies →University Hospital, Ioannina is the lead sponsor of 13 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients with physician-diagnosed asthma, recruited from outpatient and/or inpatient clinics at participating hospitals.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Time frame: From January 2026 to June 2027
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)
Time frame: From January 2026 to June 2027
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
Time frame: From January 2026 to June 2027
No study locations are listed for this record.
Plan to share: Yes — All IPD that underlie results in a publication
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Starting after the date of publication.
Access criteria: Individual participant data (IPD) and supporting information from this trial will be freely available to qualified researchers following the publication of the trial results. Access will include the de-identified participant-level dataset, study protocol, and statistical analysis plan. Researchers may request the data through the corresponding data repository link.
This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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University Hospital, Ioannina