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Evaluating the effectiveness of a fixed triple inhaled combination for asthma patients in real-life settings

Effectiveness of BDP/FF/G 172/5/9 Fixed Triple Combination on Symptom Scores in Asthma Patients After 6 Months Treatment

Observational Chiesi Hungary Ltd. · NCT06678191

This study is trying to see if a new inhaler combination can help people with uncontrolled asthma feel better after switching from their previous treatments.

Quick facts

Study typeObservational
Enrollment800 (estimated)
Ages18 Years and up
SexAll
SponsorChiesi Hungary Ltd. Industry-sponsored
Locations45 sites (Békéscsaba and 44 other locations)
Trial IDNCT06678191 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the effectiveness of the fixed triple inhaled combination of beclometasone dipropionate, formoterol fumarate, and glycopyrronium bromide (Trimbow 172/5/9 μg) in patients with uncontrolled asthma. It will evaluate symptom scores over a six-month period after switching from previous high-dose inhaled corticosteroid treatments. The study will take place in multiple centers across Hungary, enrolling patients during routine asthma management without active recruitment. The focus is on understanding the real-world impact of this therapy on asthma symptoms and quality of life.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a physician-confirmed diagnosis of uncontrolled asthma who have been treated for at least three years.

Not a fit: Patients who have participated in any clinical trial within 30 days prior to enrollment will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the real-world effectiveness of a new asthma treatment, potentially improving patient outcomes.

How similar studies have performed: While there have been randomized controlled trials showing efficacy in selected populations, this study aims to provide real-world evidence, making it a novel approach.

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 - high dose ICS OR
  2. LABA - 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 and the financing protocol for asthma

  1. At least on exacerbation, requiring systemic (oral or intravenous) corticosteroids in the previous 12 months
  2. Uncontrolled asthma (ACT≤15)
  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 CHMED\_2024/01 Prof. Dr. Lilla Tamási 8(17)
* 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

Békéscsaba and 44 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 Asthma, Chronic Obstructive Pulmonary DiseaseAsthma BronchialeAsthma therapyFixed triple inhalation treatmentTrimbow
Last reviewed 2026-06-13 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.