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

Recruiting now

Conditions studied: Asthma, Asthma Patients, Asthma Bronchiale

In brief

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.

Key facts

Study ID

NCT07489911

Run by

Chiesi Slovenija, d.o.o.

People needed

200

Starts

2024-11-04

Expected to finish

2026-07-01

Last updated by the study team

2026-03-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• AMBULANTA ARIA, specialistična ambulanta za alergijske in pljučne bolezni, d.o.o. — Celje, Slovenia (enrolling)
• Dr. ŠEGOTA - PULMOLOG, specialistične zdravstvene storitve, d.o.o. — Celje, Slovenia (enrolling)
• Internistična Ambulanta Za Pljučne in Alergijske Bolezni - Karmen Kramer Vrščaj Dr. Med. — Celje, Slovenia (enrolling)
• MEDICOINTERNA, medicinske storitve in svetovanje, d.o.o. — Kočevje, Slovenia (enrolling)
• Zdravstveni Dom Koper Casa Della Sanita Capodistria — Koper, Slovenia (enrolling)
• VELOG Zdravstveni center d.o.o. — Kranj, Slovenia (enrolling)
• ARJANA MAČEK, zdravstvene in druge storitve, d.o.o — Ljubljana, Slovenia (enrolling)
• KAMBIČ - KAFOL, medicinsko svetovanje in storitve, d.o.o. — Ljubljana, Slovenia (enrolling)
• MEDI PULMO, interna medicina, d.o.o. — Ljubljana, Slovenia (enrolling)
• OBJEM ZDRAVJA zdravstveno svetovalni center d.o.o. — Ljubljana, Slovenia (enrolling)
• PULMEDICO, specialistična zdravstvena dejavnost, d.o.o. — Ljubljana, Slovenia (enrolling)
• ALVEOLA internistični ambulantni diagnostični center d.o.o. — Maribor, Slovenia (enrolling)
• Zasebna Ambulanta Za Pljučne Bolezni, Mag. Alojz Horvat, Dr. Med. Specialist Interne Medicine — Murska Sobota, Slovenia (enrolling)
• EUPNEA d.o.o. — Murska Sobota, Slovenia (enrolling)
• Zasebna Internistično-Pulmološka Ambulanta, Jasmina Panjan Avramovič, Dr.Med.Spec. — Portorož, Slovenia (enrolling)
• DLAN, pomoč in nega na domu, specialistična zdravstvena dejavnost, Lucija Gabršček Parežnik s.p. — Šentjur pri Celju, Slovenia (enrolling)
• Zdravstveni Dom Tolmin — Tolmin, Slovenia (enrolling)
• Zdravstveni Zavod Pulmoradix Velenje — Velenje, Slovenia (enrolling)

Full record on ClinicalTrials.gov

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