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

NCT07489911 | Recruiting

• 1 other identifier: STRENGTH
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 18

Brief Summary

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

Asthma Bronchiale; Asthma; Asthma Patients

Keywords

Single Inhaler Triple Therapy; Asthma; SITT; Trimbow

Outcome Measures

Primary Outcomes (2)

• Asthma Control Test

  Change (improvement) of asthma control test (ACT) score, during the 6 months of treatment (Visit 3), compared to the score at baseline.

  6 months

• Asthma Control Test 2

  The percentage of patients achieving an improvement in asthma control test (ACT) score of 3 points (MCID, minimum clinically important difference) or more, after the 6 months treatment (Visit 3) compared to baseline.

  6 months

Secondary Outcomes (3)

• Asthma Control Test Change

  6 months

• Test of Adherence to Inhalers (TAI)

  6 months

• Lung Function

  6 months

Study Arms (1)

Asthmatic patients switched to Trimbow (BDP/FF/G 172/5/9 μg)

Drug: BDP/FF/G (beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium) 172/5/9 μg

Interventions

BDP/FF/G (beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium) 172/5/9 μg DRUG

extrafine SITT

Also known as: Trimbow 172/5/9 mcg

Asthmatic patients switched to Trimbow (BDP/FF/G 172/5/9 μg)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Asthma patients treated at GINA step 5, uncontrolled/ partially controlled with ICS+LABA, containing high dose ICS.

You may qualify if:

• 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
• 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

Sponsors & Collaborators

• Chiesi Slovenija, d.o.o.: lead

Study Sites (18)

AMBULANTA ARIA, specialistična ambulanta za alergijske in pljučne bolezni, d.o.o.

Celje, 3000, Slovenia

RECRUITING

Dr. ŠEGOTA - PULMOLOG, specialistične zdravstvene storitve, d.o.o.

Celje, 3000, Slovenia

RECRUITING

Internistična Ambulanta Za Pljučne in Alergijske Bolezni - Karmen Kramer Vrščaj Dr. Med.

Celje, 3000, Slovenia

RECRUITING

MEDICOINTERNA, medicinske storitve in svetovanje, d.o.o.

Kočevje, 1330, Slovenia

RECRUITING

Zdravstveni Dom Koper Casa Della Sanita Capodistria

Koper, 6000, Slovenia

RECRUITING

VELOG Zdravstveni center d.o.o.

Kranj, Slovenia

RECRUITING

ARJANA MAČEK, zdravstvene in druge storitve, d.o.o

Ljubljana, 1000, Slovenia

RECRUITING

KAMBIČ - KAFOL, medicinsko svetovanje in storitve, d.o.o.

Ljubljana, 1000, Slovenia

RECRUITING

MEDI PULMO, interna medicina, d.o.o.

Ljubljana, 1000, Slovenia

RECRUITING

OBJEM ZDRAVJA zdravstveno svetovalni center d.o.o.

Ljubljana, 1000, Slovenia

RECRUITING

PULMEDICO, specialistična zdravstvena dejavnost, d.o.o.

Ljubljana, 1000, Slovenia

RECRUITING

ALVEOLA internistični ambulantni diagnostični center d.o.o.

Maribor, 2000, Slovenia

RECRUITING

Zasebna Ambulanta Za Pljučne Bolezni, Mag. Alojz Horvat, Dr. Med. Specialist Interne Medicine

Murska Sobota, 9000, Slovenia

RECRUITING

EUPNEA d.o.o.

Murska Sobota, Slovenia

RECRUITING

Zasebna Internistično-Pulmološka Ambulanta, Jasmina Panjan Avramovič, Dr.Med.Spec.

Portorož, 6320, Slovenia

RECRUITING

DLAN, pomoč in nega na domu, specialistična zdravstvena dejavnost, Lucija Gabršček Parežnik s.p.

Šentjur pri Celju, 3230, Slovenia

RECRUITING

Zdravstveni Dom Tolmin

Tolmin, 5220, Slovenia

RECRUITING

Zdravstveni Zavod Pulmoradix Velenje

Velenje, 3320, Slovenia

RECRUITING

MeSH Terms

Conditions

Asthma

Interventions

Beclomethasone; Glycopyrrolate

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Mojca Pernek Miložič, MPharm

CONTACT

+38640292828; m.pernek@chiesi.com

Marina Štrucelj, MPharm

CONTACT

0038640177210; m.strucelj@chiesi.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 24, 2026
• Study Start: November 4, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 24, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

SL (18)