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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Békés Megyei Központi Kórház, 2. Tüdőgyógyászat szakrendelés - 1. rendelés
  Békéscsaba, Hungary Recruiting
• Kispesti Egészségügyi Intézet Tüdőgondozó, Ernyőképszűrő állomás
  Budapest, Hungary Recruiting
• Országos Korányi Pulmonológiai Intézet (OKPI)
  Budapest, Hungary Recruiting
• Semmelweis Egyetem, Általános Orvostudományi Kar, Pulmonológiai Klinika
  Budapest, Hungary Recruiting
• Szent Kristóf Szakrendelő XI. Kerületi Tüdőgondozó
  Budapest, Hungary Recruiting
• Szent Kristóf Szakrendelő XXII. Kerületi Tüdőgondozó
  Budapest, Hungary Recruiting

Study contacts

• Study coordinator: András Keglevich, Dr.
• Email: a.keglevich@chiesi.com
• Phone: +36309788085

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.