Real-world study of a triple inhaler for adults with asthma
Observes how a triple-combination inhaler affects symptoms in adults with asthma.
Plain-language title generated from the registry record
Registry title: Fixed Triple Inhaled Combination in Asthmatic Patients in a Real-life Setting (STRENGTH)
Key facts
- Where
- Celje, Kočevje, Koper, Kranj, Ljubljana, Maribor, Murska Sobota, Portorož, Šentjur pri Celju, Tolmin, and Velenje, SloveniaSee the 18 sites
Where in Slovenia
- AMBULANTA ARIA, specialistična ambulanta za alergijske in pljučne bolezni, d.o.o.Celje, SloveniaTaking people
- Dr. ŠEGOTA - PULMOLOG, specialistične zdravstvene storitve, d.o.o.Celje, SloveniaTaking people
- Internistična Ambulanta Za Pljučne in Alergijske Bolezni - Karmen Kramer Vrščaj Dr. Med.Celje, SloveniaTaking people
- MEDICOINTERNA, medicinske storitve in svetovanje, d.o.o.Kočevje, SloveniaTaking people
- Zdravstveni Dom Koper Casa Della Sanita CapodistriaKoper, SloveniaTaking people
- VELOG Zdravstveni center d.o.o.Kranj, SloveniaTaking people
- ARJANA MAČEK, zdravstvene in druge storitve, d.o.oLjubljana, SloveniaTaking people
- KAMBIČ - KAFOL, medicinsko svetovanje in storitve, d.o.o.Ljubljana, SloveniaTaking people
- MEDI PULMO, interna medicina, d.o.o.Ljubljana, SloveniaTaking people
- OBJEM ZDRAVJA zdravstveno svetovalni center d.o.o.Ljubljana, SloveniaTaking people
- PULMEDICO, specialistična zdravstvena dejavnost, d.o.o.Ljubljana, SloveniaTaking people
- ALVEOLA internistični ambulantni diagnostični center d.o.o.Maribor, SloveniaTaking people
- EUPNEA d.o.o.Murska Sobota, SloveniaTaking people
- Zasebna Ambulanta Za Pljučne Bolezni, Mag. Alojz Horvat, Dr. Med. Specialist Interne MedicineMurska Sobota, SloveniaTaking people
- Zasebna Internistično-Pulmološka Ambulanta, Jasmina Panjan Avramovič, Dr.Med.Spec.Portorož, SloveniaTaking people
- DLAN, pomoč in nega na domu, specialistična zdravstvena dejavnost, Lucija Gabršček Parežnik s.p.Šentjur pri Celju, SloveniaTaking people
- Zdravstveni Dom TolminTolmin, SloveniaTaking people
- Zdravstveni Zavod Pulmoradix VelenjeVelenje, SloveniaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Chiesi Slovenija, d.o.o.
- Trial code
- NCT07489911
- Record updated
- 24 March 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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:; LABA and high dose ICS or; 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 :; at least on exacerbation, requiring systemic (oral or intravenous) corticosteroids in the previous 12 months; uncontrolled asthma (ACT≤15) or partially controlled asthma (15<ACT<20); 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: 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; Continuous use of oral (>5 mg prednisolone/day OR >4 mg methylprednisolone/day) OR intravenous corticosteroids; Use of continuous oxygen therapy; Actual or previous use of biologics for asthma treatment in the past 12 months; 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; Any malignant disease in the last 5 years; Tuberculosis (active or anamnestic); All exclusion criteria listed in Trimbow 172/5/9 μg pMDI SmPC.