Actively Recruiting
Fixed Triple Inhaled Combination in Asthmatic Patients in a Real-life Setting (STRENGTH)
Led by Chiesi Slovenija, d.o.o. · Updated on 2026-03-24
200
Participants Needed
18
Research Sites
86 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Fixed Triple Inhaled Combination in Asthmatic Patients in a Real-life Setting (STRENGTH)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Physician-confirmed asthma diagnosis according to GINA guidelines, treated for at least 3 years
- Age 18 years or older in outpatient care
- Uncontrolled asthma despite use of LABA and high-dose ICS or LABA, high-dose ICS plus LAMA multi-inhaler therapy for at least 3 months
- Eligible for Trimbow 172/5/9 bcg pMDI including at least one exacerbation needing systemic corticosteroids in past 12 months, ACT score 4 or ACT 15-19, and FEV1 less than 80% at baseline
- Switched to Trimbow 172/5/9 bcg pMDI no more than 1 week before or on study inclusion day
- Provided written informed consent
You will not qualify if you...
- Participation in any clinical trial within 30 days before enrollment
- Hospitalization due to asthma exacerbation within 4 weeks before enrollment
- Other respiratory conditions besides asthma or COPD that affect treatment or compliance
- Continuous use of oral corticosteroids over 5 mg prednisolone/day or intravenous corticosteroids
- Use of continuous oxygen therapy
- Any malignant disease within last 5 years
- Active or past tuberculosis
- Use of biologic treatments for asthma in past 12 months
- Any exclusion criteria listed in Trimbow 172/5/9 bcg pMDI SmPC
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 18 locations
1
AMBULANTA ARIA, specialistična ambulanta za alergijske in pljučne bolezni, d.o.o.
Celje, Slovenia, 3000
Actively Recruiting
2
Dr. ŠEGOTA - PULMOLOG, specialistične zdravstvene storitve, d.o.o.
Celje, Slovenia, 3000
Actively Recruiting
3
Internistična Ambulanta Za Pljučne in Alergijske Bolezni - Karmen Kramer Vrščaj Dr. Med.
Celje, Slovenia, 3000
Actively Recruiting
4
MEDICOINTERNA, medicinske storitve in svetovanje, d.o.o.
Kočevje, Slovenia, 1330
Actively Recruiting
5
Zdravstveni Dom Koper Casa Della Sanita Capodistria
Koper, Slovenia, 6000
Actively Recruiting
6
VELOG Zdravstveni center d.o.o.
Kranj, Slovenia
Actively Recruiting
7
ARJANA MAČEK, zdravstvene in druge storitve, d.o.o
Ljubljana, Slovenia, 1000
Actively Recruiting
8
KAMBIČ - KAFOL, medicinsko svetovanje in storitve, d.o.o.
Ljubljana, Slovenia, 1000
Actively Recruiting
9
MEDI PULMO, interna medicina, d.o.o.
Ljubljana, Slovenia, 1000
Actively Recruiting
10
OBJEM ZDRAVJA zdravstveno svetovalni center d.o.o.
Ljubljana, Slovenia, 1000
Actively Recruiting
11
PULMEDICO, specialistična zdravstvena dejavnost, d.o.o.
Ljubljana, Slovenia, 1000
Actively Recruiting
12
ALVEOLA internistični ambulantni diagnostični center d.o.o.
Maribor, Slovenia, 2000
Actively Recruiting
13
Zasebna Ambulanta Za Pljučne Bolezni, Mag. Alojz Horvat, Dr. Med. Specialist Interne Medicine
Murska Sobota, Slovenia, 9000
Actively Recruiting
14
EUPNEA d.o.o.
Murska Sobota, Slovenia
Actively Recruiting
15
Zasebna Internistično-Pulmološka Ambulanta, Jasmina Panjan Avramovič, Dr.Med.Spec.
Portorož, Slovenia, 6320
Actively Recruiting
16
DLAN, pomoč in nega na domu, specialistična zdravstvena dejavnost, Lucija Gabršček Parežnik s.p.
Šentjur pri Celju, Slovenia, 3230
Actively Recruiting
17
Zdravstveni Dom Tolmin
Tolmin, Slovenia, 5220
Actively Recruiting
18
Zdravstveni Zavod Pulmoradix Velenje
Velenje, Slovenia, 3320
Actively Recruiting
Research Team
M
Mojca Pernek Miložič, MPharm
CONTACT
M
Marina Štrucelj, MPharm
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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