NCT07489911Recruiting
Fixed Triple Inhaled Combination in Asthmatic Patients in a Real-life Setting (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
Source: ClinicalTrials.gov · Last updated 24 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 18 Mar 2026
- Start date
- 4 Nov 2024
- Primary completion date
- Jul 2026
- Lead sponsor
- Chiesi Slovenija, d.o.o.
- Diseases
- Asthma
- NCT number
- NCT07489911
What you commit to
- Study type: Observational
- Planned participants: 200
- From 4 Nov 2024 to the primary completion date, Jul 2026
- 18 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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)
Other
- All exclusion criteria listed in Trimbow 172/5/9 μg pMDI SmPC
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (18)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| AMBULANTA ARIA, specialistična ambulanta za alergijske in pljučne bolezni, d.o.o. Coordinator of this site? Confirm its status | Celje | Slovenia | Recruiting |
| Internistična Ambulanta Za Pljučne in Alergijske Bolezni - Karmen Kramer Vrščaj Dr. Med. Coordinator of this site? Confirm its status | Celje | Slovenia | Recruiting |
| Dr. ŠEGOTA - PULMOLOG, specialistične zdravstvene storitve, d.o.o. Coordinator of this site? Confirm its status | Celje | Slovenia | Recruiting |
| MEDICOINTERNA, medicinske storitve in svetovanje, d.o.o. Coordinator of this site? Confirm its status | Kočevje | Slovenia | Recruiting |
| Zdravstveni Dom Koper Casa Della Sanita Capodistria Coordinator of this site? Confirm its status | Koper | Slovenia | Recruiting |
| VELOG Zdravstveni center d.o.o. Coordinator of this site? Confirm its status | Kranj | Slovenia | Recruiting |
| ARJANA MAČEK, zdravstvene in druge storitve, d.o.o Coordinator of this site? Confirm its status | Ljubljana | Slovenia | Recruiting |
| OBJEM ZDRAVJA zdravstveno svetovalni center d.o.o. Coordinator of this site? Confirm its status | Ljubljana | Slovenia | Recruiting |
| PULMEDICO, specialistična zdravstvena dejavnost, d.o.o. Coordinator of this site? Confirm its status | Ljubljana | Slovenia | Recruiting |
| KAMBIČ - KAFOL, medicinsko svetovanje in storitve, d.o.o. Coordinator of this site? Confirm its status | Ljubljana | Slovenia | Recruiting |
| MEDI PULMO, interna medicina, d.o.o. Coordinator of this site? Confirm its status | Ljubljana | Slovenia | Recruiting |
| ALVEOLA internistični ambulantni diagnostični center d.o.o. Coordinator of this site? Confirm its status | Maribor | Slovenia | Recruiting |
| EUPNEA d.o.o. Coordinator of this site? Confirm its status | Murska Sobota | Slovenia | Recruiting |
| Zasebna Ambulanta Za Pljučne Bolezni, Mag. Alojz Horvat, Dr. Med. Specialist Interne Medicine Coordinator of this site? Confirm its status | Murska Sobota | Slovenia | Recruiting |
| Zasebna Internistično-Pulmološka Ambulanta, Jasmina Panjan Avramovič, Dr.Med.Spec. Coordinator of this site? Confirm its status | Portorož | Slovenia | Recruiting |
| DLAN, pomoč in nega na domu, specialistična zdravstvena dejavnost, Lucija Gabršček Parežnik s.p. Coordinator of this site? Confirm its status | Šentjur pri Celju | Slovenia | Recruiting |
| Zdravstveni Dom Tolmin Coordinator of this site? Confirm its status | Tolmin | Slovenia | Recruiting |
| Zdravstveni Zavod Pulmoradix Velenje Coordinator of this site? Confirm its status | Velenje | Slovenia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.