AsthmaMATRIXNCT07372521
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
An observational study of Asthma, run by University Hospital, Ioannina.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- 19 Jan 2026to 31 Jan 2028
- How long will I take part?
- 52 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with physician-diagnosed asthma, recruited from outpatient and/or inpatient clinics at participating hospitals.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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: The MATRIX Real-life Observational Study
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)?
Read more
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).
Read the detailed description
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).
- At all 3 Visits, the following assessments will be performed to all patients: (1) Evaluation of asthma control (ACT, ACQ-5), (2) Blood Eosinophil Counts (BEC, cells/mL and %), (3) FeNO (FeNO+, MGC Diagnostics, at 50 mL/sec and at 100 and 150 mL/sec to measure alveolar NO as a marker of SAD), (4) Forced Oscillometry Technique (FOT, Resmon PRO Full V3), measuring peripheral resistance (difference between resistance at 5Hz and 19Hz, R5-19), frequency resonance (Fres), area of reactance (AX), and reactance (X5), (5) Simple spirometry, including forced expiratory volume in 1 sec (FEV1), forced vital capacity (FVC), FEV1/FVC ratio, and forced expiratory flow at 25-75% of FVC (FEF25-75%), (6) Static lung volumes by body plethysmography, including total lung capacity (TLC), residual volume (RV), and functional residual capacity (FRC), (7) At the optional Visit 4 at 52 weeks, we will collect the previous parameters and the number of exacerbations (OCS courses, emergency department visits, hospitalizations). 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.
- Conditions
- Asthma
- Keywords
- Asthma, Clinical Trials, Phase IV as Topic, Drug Therapy, Combination, LABA, LAMA, ICS, Oscillometry, Respiratory Function Tests, FeNO
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Males and females out-patients aged ≥18 years with uncontrolled asthma on ICS/LABA treatment | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From January 2026 to June 2027
Secondary outcomes (1)
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)
Measured: From January 2026 to June 2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start19 Jan 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
- Target duration
- 52 Weeks
Sponsor and investigators
- Lead sponsor
- University Hospital, Ioannina
- Sponsor type
- University, hospital or other
- Collaborators
- Attikon Hospital, 424 General Military Hospital, George Papanicolaou Hospital, University Hospital of Patras, University Hospital, Alexandroupolis
- Responsible party
- Principal investigator, Konstantinos Kostikas, University Hospital, Ioannina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07372521
- Sponsor's protocol ID
- RMDUoI-001
- Other IDs
- University Hospital Ioannina
- Acronym
- MATRIX
- Status last verified
- Jan 2026
- First submitted
- 11 Jan 2026
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Publications
Gogali A, Kostikas K, Kyriakopoulos C, Potonos D, Porpodis K, Tsiouprou I, Fouka E, Tryfon S, Papadopoulou E, Kipourou M, Katsoulis K. Managing Small Airways Dysfunction in COPD Patients in Real Life Under Fixed Triple Combination of Beclomethasone/Formoterol/Glycopyrronium: The MASCOT Real World Evidence Study. Int J Chron Obstruct Pulmon Dis. 2025 May 23;20:1651-1663. doi: 10.2147/COPD.S513350. eCollection 2025.
PubMed 40433397Bhakta NR, McGowan A, Ramsey KA, Borg B, Kivastik J, Knight SL, Sylvester K, Burgos F, Swenson ER, McCarthy K, Cooper BG, Garcia-Rio F, Skloot G, McCormack M, Mottram C, Irvin CG, Steenbruggen I, Coates AL, Kaminsky DA. European Respiratory Society/American Thoracic Society technical statement: standardisation of the measurement of lung volumes, 2023 update. Eur Respir J. 2023 Oct 12;62(4):2201519. doi: 10.1183/13993003.01519-2022. Print 2023 Oct.
PubMed 37500112Santanello NC, Zhang J, Seidenberg B, Reiss TF, Barber BL. What are minimal important changes for asthma measures in a clinical trial? Eur Respir J. 1999 Jul;14(1):23-7. doi: 10.1034/j.1399-3003.1999.14a06.x.
PubMed 10489824Stanojevic S, Kaminsky DA, Miller MR, Thompson B, Aliverti A, Barjaktarevic I, Cooper BG, Culver B, Derom E, Hall GL, Hallstrand TS, Leuppi JD, MacIntyre N, McCormack M, Rosenfeld M, Swenson ER. ERS/ATS technical standard on interpretive strategies for routine lung function tests. Eur Respir J. 2022 Jul 13;60(1):2101499. doi: 10.1183/13993003.01499-2021. Print 2022 Jul.
PubMed 34949706Juniper EF, Buist AS, Cox FM, Ferrie PJ, King DR. Validation of a standardized version of the Asthma Quality of Life Questionnaire. Chest. 1999 May;115(5):1265-70. doi: 10.1378/chest.115.5.1265.
PubMed 10334138Juniper EF, O'Byrne PM, Guyatt GH, Ferrie PJ, King DR. Development and validation of a questionnaire to measure asthma control. Eur Respir J. 1999 Oct;14(4):902-7. doi: 10.1034/j.1399-3003.1999.14d29.x.
PubMed 10573240Nathan RA, Sorkness CA, Kosinski M, Schatz M, Li JT, Marcus P, Murray JJ, Pendergraft TB. Development of the asthma control test: a survey for assessing asthma control. J Allergy Clin Immunol. 2004 Jan;113(1):59-65. doi: 10.1016/j.jaci.2003.09.008.
PubMed 14713908Galant SP, Kuks PJM, Kole TM, Kraft M, Siddiqui S, Fabbri LM, Beghe B, Rabe KF, Papi A, Brightling CE, Singh D, Kocks JWH, Franzini L, Vonk JM, Kerstjens HAM, Heijink IH, Pouwels SD, Slebos DJ, van den Berge M. Assessment of the role of small airway dysfunction in relation to exacerbation risk in patients with well controlled asthma (ATLANTIS): an observational study. Lancet Respir Med. 2025 Nov;13(11):990-1000. doi: 10.1016/S2213-2600(25)00283-8. Epub 2025 Sep 29.
PubMed 410382132025 GINA Strategy Report [Internet]. Global Initiative for Asthma - GINA 2025 [cited 2025 Oct 28]. Available from: https://ginasthma.org/2025-gina-strategy-report/).
Papi A, Singh D, Virchow JC, Canonica GW, Vele A, Georges G. Normalisation of airflow limitation in asthma: Post-hoc analyses of TRIMARAN and TRIGGER. Clin Transl Allergy. 2022 Apr 17;12(4):e12145. doi: 10.1002/clt2.12145. eCollection 2022 Apr.
PubMed 35450196Quaranta VN, Montagnolo F, Portacci A, Dragonieri S, Granito M, Rociola G, Ferrulli S, Maselli L, Carpagnano GE. Steady Quiet Asthma Without Biologics: One-Year Outcomes of Single-Inhaler Triple Therapy for Severe Asthma with Small Airway Dysfunction. J Clin Med. 2025 Aug 7;14(15):5602. doi: 10.3390/jcm14155602.
PubMed 40807224Carpagnano GE, Scioscia G, Lacedonia D, Stornelli SR, Irene Quarato CM, Soccio P, Resta O, Foschino Barbaro MP. Treatment response according to small airways disease status: The effects of high-strength extrafine pMDI beclomethasone dipropionate/formoterol fumarate in fixed dose combination in moderate uncontrolled asthmatic patients. Pulm Pharmacol Ther. 2020 Feb;60:101879. doi: 10.1016/j.pupt.2019.101879. Epub 2019 Dec 20.
PubMed 31866498Scichilone N, Battaglia S, Sorino C, Paglino G, Martino L, Paterno A, Santagata R, Spatafora M, Nicolini G, Bellia V. Effects of extra-fine inhaled beclomethasone/formoterol on both large and small airways in asthma. Allergy. 2010 Jul;65(7):897-902. doi: 10.1111/j.1398-9995.2009.02306.x. Epub 2010 Jan 28.
PubMed 20121764Virchow JC, Kuna P, Paggiaro P, Papi A, Singh D, Corre S, Zuccaro F, Vele A, Kots M, Georges G, Petruzzelli S, Canonica GW. Single inhaler extrafine triple therapy in uncontrolled asthma (TRIMARAN and TRIGGER): two double-blind, parallel-group, randomised, controlled phase 3 trials. Lancet. 2019 Nov 9;394(10210):1737-1749. doi: 10.1016/S0140-6736(19)32215-9. Epub 2019 Sep 30.
PubMed 31582314Kraft M, Richardson M, Hallmark B, Billheimer D, Van den Berge M, Fabbri LM, Van der Molen T, Nicolini G, Papi A, Rabe KF, Singh D, Brightling C, Siddiqui S; ATLANTIS study group. The role of small airway dysfunction in asthma control and exacerbations: a longitudinal, observational analysis using data from the ATLANTIS study. Lancet Respir Med. 2022 Jul;10(7):661-668. doi: 10.1016/S2213-2600(21)00536-1. Epub 2022 Mar 2.
PubMed 35247313
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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: The MATRIX Real-life Observational Study
- ClinicalTrials.gov ID
- NCT07372521
- Acronym / sponsor ID
- MATRIX / RMDUoI-001
- Conditions
- Asthma
- Keywords
- Asthma, Clinical Trials, Phase IV as Topic, Drug Therapy, Combination, LABA, LAMA, ICS, Oscillometry, Respiratory Function Tests
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- University Hospital, IoanninaUniversity, hospital or other
- Collaborators
- Attikon Hospital, 424 General Military Hospital, George Papanicolaou Hospital, University Hospital of Patras, University Hospital, Alexandroupolis
- Study start
- 19 Jan 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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).
- At all 3 Visits, the following assessments will be performed to all patients: (1) Evaluation of asthma control (ACT, ACQ-5), (2) Blood Eosinophil Counts (BEC, cells/mL and %), (3) FeNO (FeNO+, MGC Diagnostics, at 50 mL/sec and at 100 and 150 mL/sec to measure alveolar NO as a marker of SAD), (4) Forced Oscillometry Technique (FOT, Resmon PRO Full V3), measuring peripheral resistance (difference between resistance at 5Hz and 19Hz, R5-19), frequency resonance (Fres), area of reactance (AX), and reactance (X5), (5) Simple spirometry, including forced expiratory volume in 1 sec (FEV1), forced vital capacity (FVC), FEV1/FVC ratio, and forced expiratory flow at 25-75% of FVC (FEF25-75%), (6) Static lung volumes by body plethysmography, including total lung capacity (TLC), residual volume (RV), and functional residual capacity (FRC), (7) At the optional Visit 4 at 52 weeks, we will collect the previous parameters and the number of exacerbations (OCS courses, emergency department visits, hospitalizations). 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 52 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Males and females out-patients aged ≥18 years with uncontrolled asthma on ICS/LABA treatment | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with physician-diagnosed asthma, recruited from outpatient and/or inpatient clinics at participating hospitals.
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Small airways function and Oscillometry
Time frame: From January 2026 to June 2027
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
1 secondary outcome
Pulmonary test function results and Questionnaires
Time frame: From January 2026 to June 2027
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Background: PubMed 40433397Gogali A, Kostikas K, Kyriakopoulos C, Potonos D, Porpodis K, Tsiouprou I, Fouka E, Tryfon S, Papadopoulou E, Kipourou M, Katsoulis K. Managing Small Airways Dysfunction in COPD Patients in Real Life Under Fixed Triple Combination of Beclomethasone/Formoterol/Glycopyrronium: The MASCOT Real World Evidence Study. Int J Chron Obstruct Pulmon Dis. 2025 May 23;20:1651-1663. doi: 10.2147/COPD.S513350. eCollection 2025.
- Background: PubMed 37500112Bhakta NR, McGowan A, Ramsey KA, Borg B, Kivastik J, Knight SL, Sylvester K, Burgos F, Swenson ER, McCarthy K, Cooper BG, Garcia-Rio F, Skloot G, McCormack M, Mottram C, Irvin CG, Steenbruggen I, Coates AL, Kaminsky DA. European Respiratory Society/American Thoracic Society technical statement: standardisation of the measurement of lung volumes, 2023 update. Eur Respir J. 2023 Oct 12;62(4):2201519. doi: 10.1183/13993003.01519-2022. Print 2023 Oct.
- Background: PubMed 10489824Santanello NC, Zhang J, Seidenberg B, Reiss TF, Barber BL. What are minimal important changes for asthma measures in a clinical trial? Eur Respir J. 1999 Jul;14(1):23-7. doi: 10.1034/j.1399-3003.1999.14a06.x.
- Background: PubMed 34949706Stanojevic S, Kaminsky DA, Miller MR, Thompson B, Aliverti A, Barjaktarevic I, Cooper BG, Culver B, Derom E, Hall GL, Hallstrand TS, Leuppi JD, MacIntyre N, McCormack M, Rosenfeld M, Swenson ER. ERS/ATS technical standard on interpretive strategies for routine lung function tests. Eur Respir J. 2022 Jul 13;60(1):2101499. doi: 10.1183/13993003.01499-2021. Print 2022 Jul.
- Background: PubMed 10334138Juniper EF, Buist AS, Cox FM, Ferrie PJ, King DR. Validation of a standardized version of the Asthma Quality of Life Questionnaire. Chest. 1999 May;115(5):1265-70. doi: 10.1378/chest.115.5.1265.
- Background: PubMed 10573240Juniper EF, O'Byrne PM, Guyatt GH, Ferrie PJ, King DR. Development and validation of a questionnaire to measure asthma control. Eur Respir J. 1999 Oct;14(4):902-7. doi: 10.1034/j.1399-3003.1999.14d29.x.
- Background: PubMed 14713908Nathan RA, Sorkness CA, Kosinski M, Schatz M, Li JT, Marcus P, Murray JJ, Pendergraft TB. Development of the asthma control test: a survey for assessing asthma control. J Allergy Clin Immunol. 2004 Jan;113(1):59-65. doi: 10.1016/j.jaci.2003.09.008.
- Background: PubMed 41038213Galant SP, Kuks PJM, Kole TM, Kraft M, Siddiqui S, Fabbri LM, Beghe B, Rabe KF, Papi A, Brightling CE, Singh D, Kocks JWH, Franzini L, Vonk JM, Kerstjens HAM, Heijink IH, Pouwels SD, Slebos DJ, van den Berge M. Assessment of the role of small airway dysfunction in relation to exacerbation risk in patients with well controlled asthma (ATLANTIS): an observational study. Lancet Respir Med. 2025 Nov;13(11):990-1000. doi: 10.1016/S2213-2600(25)00283-8. Epub 2025 Sep 29.
- Background2025 GINA Strategy Report [Internet]. Global Initiative for Asthma - GINA 2025 [cited 2025 Oct 28]. Available from: https://ginasthma.org/2025-gina-strategy-report/).
- Background: PubMed 35450196Papi A, Singh D, Virchow JC, Canonica GW, Vele A, Georges G. Normalisation of airflow limitation in asthma: Post-hoc analyses of TRIMARAN and TRIGGER. Clin Transl Allergy. 2022 Apr 17;12(4):e12145. doi: 10.1002/clt2.12145. eCollection 2022 Apr.
- Background: PubMed 40807224Quaranta VN, Montagnolo F, Portacci A, Dragonieri S, Granito M, Rociola G, Ferrulli S, Maselli L, Carpagnano GE. Steady Quiet Asthma Without Biologics: One-Year Outcomes of Single-Inhaler Triple Therapy for Severe Asthma with Small Airway Dysfunction. J Clin Med. 2025 Aug 7;14(15):5602. doi: 10.3390/jcm14155602.
- Background: PubMed 31866498Carpagnano GE, Scioscia G, Lacedonia D, Stornelli SR, Irene Quarato CM, Soccio P, Resta O, Foschino Barbaro MP. Treatment response according to small airways disease status: The effects of high-strength extrafine pMDI beclomethasone dipropionate/formoterol fumarate in fixed dose combination in moderate uncontrolled asthmatic patients. Pulm Pharmacol Ther. 2020 Feb;60:101879. doi: 10.1016/j.pupt.2019.101879. Epub 2019 Dec 20.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by University Hospital, Ioannina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Konstantinos Kostikas, Professor (+302651007536, ktkostikas@uoi.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Small airways function and Oscillometry (time frame: From January 2026 to June 2027). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07372521, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.