Actively Recruiting

Age: 18Years +
All Genders
NCT07489911

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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