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Trimbow fixed triple inhaler for adults with uncontrolled asthma in routine care

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

Observational Chiesi Slovenija, d.o.o. · NCT07489911

This project will try Trimbow (beclometasone/formoterol/glycopyrronium) in adults with uncontrolled asthma who switch from high‑dose ICS/LABA or multiple‑inhaler triple therapy to see if symptoms and adherence improve over six months.

Quick facts

Study typeObservational
Enrollment200 (estimated)
Ages18 Years and up
SexAll
SponsorChiesi Slovenija, d.o.o. Industry-sponsored
Locations18 sites (Celje and 17 other locations)
Trial IDNCT07489911 on ClinicalTrials.gov

What this trial studies

This is a multicentre, national, non‑interventional prospective study enrolling adult patients with physician‑confirmed asthma who switched to Trimbow (172/5/9 µg pMDI). Participants receive the recommended two inhalations twice daily and are followed for six months with visits at baseline and month six to record symptom scores (ACT), lung function, exacerbations, and adherence. The primary outcome is change in ACT score at six months and the proportion of patients achieving a minimum clinically important difference of ≥3 points. The study is conducted in outpatient respiratory clinics in Celje, Slovenia, to capture real‑world effectiveness outside randomized trial settings.

Who should consider this trial

Good fit: Adults (≥18) with physician‑confirmed asthma treated for ≥3 years who remain uncontrolled despite high‑dose ICS/LABA or multi‑inhaler triple therapy, with recent exacerbation and baseline ACT and FEV1 criteria, and who switch to Trimbow within one week are the intended participants.

Not a fit: Patients with well‑controlled asthma, those whose symptoms are driven by non‑asthma respiratory conditions, or individuals with contraindications to any component of Trimbow are unlikely to gain benefit from switching in this setting.

Why it matters

Potential benefit: If successful, Trimbow could improve symptom control and adherence for adults with uncontrolled asthma, potentially reducing exacerbations and systemic steroid use.

How similar studies have performed: Randomized controlled trials have shown efficacy and safety for fixed triple inhalers like Trimbow in selected populations, but real‑world data on symptom improvement and adherence remain limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
INCLUSION CRITERIA:

* 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:

  1. LABA and high dose ICS or
  2. 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 :

  1. at least on exacerbation, requiring systemic (oral or intravenous) corticosteroids in the previous 12 months
  2. uncontrolled asthma (ACT≤15) or partially controlled asthma (15\<ACT\<20)
  3. 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

EXCLUSION CRITERIA:

* 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 this trial is running

Celje and 17 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions AsthmaAsthma PatientsAsthma BronchialeSingle Inhaler Triple TherapySITTTrimbow
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.