Fixed Triple Inhaled Combination in Asthmatic Patients in a Real-life Setting (STRENGTH) (STRENGTH)

A Prospective Non-Interventional Real-world Study Assessing the Effectiveness of Extrafine BDP/FF/G HS Single Inhaler Triple Therapy (SITT) on Symptom Scores in Asthma Patients After 6 Months Treatment

The mainstay of asthma treatment are ICSs, mostly combined with LABA. In the past decade LAMA had been accepted as an add-on treatment for patients at GINA steps 4 and 5. Recently, RCTs proved the efficacy and safety of fixed triple combinations of moderate and high dose of ICS and LABA, LAMA in a very selected asthmatic population, resulting in the market authorisation of these products. However, there is a lack of evidence on the real-world effectiveness of these therapies, especially with regards to improvement in symptom scores and adherence.

Study Overview

• Status: Recruiting
• Conditions: Asthma; Asthma Bronchiale; Asthma Patients
• Intervention / Treatment: Drug: BDP/FF/G (beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium) 172/5/9 μg

Detailed Description

Study design Multicentre, national, non-interventional, prospective study evaluating the effectiveness of Trimbow 172/5/9 μg pMDI on symptom scores in 6 months after switch from previous LABA-high dose ICS containing treatment in asthmatics.

Dosage regimen and administration Name of the product: Trimbow 172 micrograms/5 micrograms/9 micrograms pressurised inhalation, solution (henceforth abbreviated as Trimbow 172/5/9 µg pMDI) . Each delivered dose (the dose leaving the mouthpiece) contains 172 µg of beclometasone dipropionate, 5 µg of formoterol fumarate dihydrate and 9 µg of glycopyrronium (as 11 µg glycopyrronium bromide). Each metered dose (the dose leaving the valve) contains 200 µg of beclometasone dipropionate, 6 µg of formoterol fumarate dihydrate and 10 µg of glycopyrronium (as 12.5 µg glycopyrronium bromide). The recommended dose is two inhalations twice daily. The maximum dose is two inhalations twice daily.

1. AIM OF THE STUDY (research objective)

   Primary objective:

   The main objective is to assess the effectiveness of BDP/FF/G 172/5/9 μg fixed triple combination in a real-world setting, with regards to improvements in symptom scores (ACT).

   Primary outcome measures:

   • Change (improvement) of ACT score, during the 6 months of treatment (Visit 3), compared to the score at baseline.
   • The percentage of patients achieving an improvement in ACT score of 3 points (MCID, minimum clinically important difference) or more, after the 6 months treatment (Visit 3) compared to baseline.

   Secondary objectives:

   Secondary objectives are the assessments of improvement in lung function and adherence to treatment.

2. TEST SAMPLE AND METHOD, RECRUITMENT PRINCIPLE No patient recruitment will be performed. Eligible patients will be enrolled during their regular asthma management with participating physicians after giving their written informed consent. Patient inclusion will take place among patients having severe asthma and attending pulmonology outpatient clinics (the chosen study sites are attached as annexes to the study protocol), strictly at the time of the patient's visit. The planned number of patients is 200.

3. STRUCTURE OF THE STUDY In accordance with the requirements of non-interventional studies, the assignment of patients to Trimbow 172/5/9 μg pMDI therapy should be made independently of the study, and patients should only be considered for inclusion in the study after a prior therapeutic decision has been made by a pulmonologist. Patient enrolment can take place after the patient has been fully informed about the purpose of the study and all of its details, and the patient has read and signed the patient information leaflet and patient consent form, including any questions they may have. Once this has taken place, the data that would have been generated anyway during the outpatient examination of the patient in accordance with daily practice can be recorded. This is considered the first visit of the study (Visit 1). During this visit, the patient's main demographic data, information on comorbidities and concomitant medications, previous and current asthma therapies, asthma specific assessment (including ACT), exacerbation history, post-dose lung function values (if spirometry data is available), laboratory results (if a laboratory test is performed), maintenance and reliever inhaled therapies (former and new), and adherence to therapy based on Test of Adherence to Inhalers (TAI-12) questionnaire are recorded. Patients will then attend two additional visits 30 days and 6 months after enrolment as per routine clinical practice (Visits 2 and 3). During these visits, data will also be recorded, once again, according to routine clinical practice.

   If the patient's maintenance therapy changes during the study as decided by the treating pulmonologist, and the patient is no longer receiving Trimbow 172/5/9 μg pMDI, the patient will be automatically excluded from this NIS. The fact of the therapy modification and its exact date must be recorded on the "current medication" form in the eCRF (electronic Case Report Form) of the next visit. If the change in therapy is related to a suspected adverse reaction, it should be reported separately on the eCRF platform in accordance with respective section of this protocol.

   This NIS is open to all eligible patients according to the inclusion and exclusion criteria. Permitted concomitant treatments: allowed all medications according to local clinical practice (any non-inhalation therapy for asthma or other diseases) and reliever (short-acting bronchodilators) inhaled therapies for asthma.

4. START AND DURATION OF THE STUDY The first patient enrolment will take place after receiving approval from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia, based on a beneficial assessment of the National Medical Ethics Committee of the Republic of Slovenia. The study is planned to start in November 2024. Accordingly, first patient first visit (FPFV) is also planned to take place in November, 2024. Study sites will have 12 months to enrol patients. After the last visit of the last patient (LPLV), centres will have one month to collect all missing data / correct any data flagged as queries during monitoring. The LPLV is expected to take place in June 2026.

5. STUDY PLAN A total of 3 visits will be performed for the assessment of the primary and secondary endpoints during the study. Patient may be enrolled in the study and their data may only be recorded, if these data would also have been recorded in accordance with standard medical practice.

   • Visit 1: Time of enrolment - a normal visit, according to routine clinical practice. Informed consent and baseline patient characteristics will be collected.
   • Visit 2: 1 month after enrolment (± 2-3 days)
   • Visit 3: 6 months after enrolment (± 5-7 days)

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Mojca Pernek Miložič, MPharm; Phone Number: +38640292828; Email: m.pernek@chiesi.com
• Study Contact Backup: Name: Marina Štrucelj, MPharm; Phone Number: 0038640177210; Email: m.strucelj@chiesi.com

Study Locations

• Slovenia
  • Celje, Slovenia, 3000
    • Recruiting
    • AMBULANTA ARIA, specialistična ambulanta za alergijske in pljučne bolezni, d.o.o.
    • Contact: JASMINA DIMITRIJEVIĆ GOLEŽ, MD; Phone Number: +38631315042; Email: jasmina.golez@gmail.com
  • Celje, Slovenia, 3000
    • Recruiting
    • Dr. ŠEGOTA - PULMOLOG, specialistične zdravstvene storitve, d.o.o.
    • Contact: NIKŠA ŠEGOTA, MD; Phone Number: +38634923730; Email: segota.niksa@siol.net
  • Celje, Slovenia, 3000
    • Recruiting
    • Internistična Ambulanta Za Pljučne in Alergijske Bolezni - Karmen Kramer Vrščaj Dr. Med.
    • Contact: KARMEN KRAMER VRŠČAJ, MD; Phone Number: +38634930640; Email: karmen.kramervrscaj@internisticna-ambulanta.si
  • Koper, Slovenia, 6000
    • Recruiting
    • Zdravstveni Dom Koper Casa Della Sanita Capodistria
    • Contact: BRANISLAV ČERVENJAK, MD; Phone Number: +38656647100; Email: branislav.cervenjak@gmail.com
  • Kočevje, Slovenia, 1330
    • Recruiting
    • MEDICOINTERNA, medicinske storitve in svetovanje, d.o.o.
    • Contact: DUŠAN BOŽIČ, MD; Phone Number: +38618938570; Email: dusan.bozic@medicointerna.com
  • Kranj, Slovenia
    • Recruiting
    • VELOG Zdravstveni center d.o.o.
    • Contact: Tjaša Šubic, MD; Phone Number: 0038642380011; Email: tjasa.subic@gmail.com
  • Ljubljana, Slovenia, 1000
    • Recruiting
    • ARJANA MAČEK, zdravstvene in druge storitve, d.o.o
    • Contact: ARJANA MACEK CAFUTA, MD; Phone Number: +38651383815; Email: macek.arjana@gmail.com
  • Ljubljana, Slovenia, 1000
    • Recruiting
    • KAMBIČ - KAFOL, medicinsko svetovanje in storitve, d.o.o.
    • Contact: ALJOŠA DUKIC, MD; Phone Number: +38651345400; Email: aljosa_dukic@t-2.net
  • Ljubljana, Slovenia, 1000
    • Recruiting
    • MEDI PULMO, interna medicina, d.o.o.
    • Contact: RENATO ERŽEN, MD; Phone Number: +38612562390; Email: renato.erzen@medipulmo.com
  • Ljubljana, Slovenia, 1000
    • Recruiting
    • OBJEM ZDRAVJA zdravstveno svetovalni center d.o.o.
    • Contact: MIHAELA ZIDARN, MD; Phone Number: +38659012579; Email: mihaela.zidarn@objemzdravja.si
  • Ljubljana, Slovenia, 1000
    • Recruiting
    • PULMEDICO, specialistična zdravstvena dejavnost, d.o.o.
    • Contact: NISSERA BAJROVIC, MD; Phone Number: +38664299900; Email: nissera.bajrovic@pulmedico.si
  • Maribor, Slovenia, 2000
    • Recruiting
    • ALVEOLA internistični ambulantni diagnostični center d.o.o.
    • Contact: ZORAN KRSTIC, MD; Phone Number: +38622348800; Email: zorankrstic.md@gmail.com
  • Murska Sobota, Slovenia, 9000
    • Recruiting
    • Zasebna Ambulanta Za Pljučne Bolezni, Mag. Alojz Horvat, Dr. Med. Specialist Interne Medicine
    • Contact: ALOJZ HORVAT, MD; Phone Number: +38625351404; Email: lti@siol.net
  • Murska Sobota, Slovenia
    • Recruiting
    • EUPNEA d.o.o.
    • Contact: Anton Lopert, MD; Phone Number: 0038625349222; Email: anton.lopert@siol.net
  • Portorož, Slovenia, 6320
    • Recruiting
    • Zasebna Internistično-Pulmološka Ambulanta, Jasmina Panjan Avramovič, Dr.Med.Spec.
    • Contact: JASMINA PANJAN AVRAMOVIC, MD; Phone Number: +38656771439; Email: jasmina.minchi@gmail.com
  • Tolmin, Slovenia, 5220
    • Recruiting
    • Zdravstveni Dom Tolmin
    • Contact: LUCAS GAUDENCIO TRIEP, MD; Phone Number: +38653881120; Email: lucastriep@gmail.com
  • Velenje, Slovenia, 3320
    • Recruiting
    • Zdravstveni Zavod Pulmoradix Velenje
    • Contact: ANA NOVAKOVIC, MD; Phone Number: +38659255000; Email: ana@pulmolog.com
  • Šentjur pri Celju, Slovenia, 3230
    • Recruiting
    • DLAN, pomoč in nega na domu, specialistična zdravstvena dejavnost, Lucija Gabršček Parežnik s.p.
    • Contact: LUCIJA GABRŠČEK PAREŽNIK, MD; Phone Number: +386781615000; Email: kataluga@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Asthma patients treated at GINA step 5, uncontrolled/ partially controlled with ICS+LABA, containing high dose ICS.

Description

INCLUSION CRITERIA:

• Physician-confirmed clinical diagnosis of asthma according to GINA guidelines and treated for at least 3 years before inclusion
• Patients ≥ 18 years of age in ambulatory care

• Uncontrolled asthma according to the physician's clinical assessment despite the use of:

  1. LABA and high dose ICS or
  2. LABA and high-dose ICS + LAMA multi-inhaler triple therapy for a minimum of three months.

• Patients who are eligible for the use of Trimbow 172/5/9 μg pMDI according to the SmPC :

  1. at least on exacerbation, requiring systemic (oral or intravenous) corticosteroids in the previous 12 months
  2. uncontrolled asthma (ACT≤15) or partially controlled asthma (15<ACT<20)
  3. FEV1<80% at baseline
• Inhaled asthma therapy was changed to Trimbow 172/5/9 μg pMDI no more than 1 week prior to OR on the day of study inclusion
• Patient provided written, informed consent to study participation

EXCLUSION CRITERIA:

• Participation in any clinical trial within 30 days prior to enrolment
• Patients hospitalized due to an exacerbation of their asthma within the last 4 weeks prior to enrolment
• Another respiratory condition, apart from asthma or COPD, that may interfere with the effectiveness of the treatment studied AND/OR another important clinical situation that may interfere with patient's compliance with the treatment.
• Continuous use of oral (>5 mg prednisolone/day OR >4 mg methylprednisolone/day) OR intravenous corticosteroids
• Use of continuous oxygen therapy
• Any malignant disease in the last 5 years
• Tuberculosis (active or anamnestic)
• Actual or previous use of biologics for asthma treatment in the past 12 months
• All exclusion criteria listed in Trimbow 172/5/9 μg pMDI SmPC

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Asthmatic patients switched to Trimbow (BDP/FF/G 172/5/9 μg)	Drug: BDP/FF/G (beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium) 172/5/9 μg; extrafine SITT; Other Names: Trimbow 172/5/9 mcg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asthma Control Test	Change (improvement) of asthma control test (ACT) score, during the 6 months of treatment (Visit 3), compared to the score at baseline.	6 months
Asthma Control Test 2	The percentage of patients achieving an improvement in asthma control test (ACT) score of 3 points (MCID, minimum clinically important difference) or more, after the 6 months treatment (Visit 3) compared to baseline.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asthma Control Test Change	The percentage of patients achieving an improvement according to asthma control levels (uncontrolled= ACT ≤15; partially controlled= 15<ACT<20; controlled 20≤ACT)	6 months
Test of Adherence to Inhalers (TAI)	Change in Test of Adherence to Inhalers® (TAI-12) score at Visit 3 (6 months) compared to baseline visit (Visit 1, week 0) regarding adherence to treatment with use of the Trimbow 172/5/9 μg pMDI.	6 months
Lung Function	Change in spirometric parameters: FEV1, FVC, FEV1/FVC, at Visit 3 (6 months), compared to the baseline Visit 1 (Week 0), with use of the Trimbow 172/5/9 μg pMDI.	6 months

Collaborators and Investigators

• Sponsor: Chiesi Slovenija, d.o.o.

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: March 18, 2026
• First Submitted That Met QC Criteria: March 18, 2026
• First Posted (Actual): March 24, 2026

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Asthma; Trimbow; SITT; Single Inhaler Triple Therapy
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds; Amines; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Pregnadienetriols; Quaternary Ammonium Compounds; Onium Compounds; Pyrrolidines; Steroids, Chlorinated; Beclomethasone; Glycopyrrolate
• Other Study ID Numbers: STRENGTH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IDP is sole property of the sponsor and will only be eligible upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No