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

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 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.

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 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 it's running

• AMBULANTA ARIA, specialistična ambulanta za alergijske in pljučne bolezni, d.o.o.
  Celje, Slovenia Recruiting
• Dr. ŠEGOTA - PULMOLOG, specialistične zdravstvene storitve, d.o.o.
  Celje, Slovenia Recruiting
• Internistična Ambulanta Za Pljučne in Alergijske Bolezni - Karmen Kramer Vrščaj Dr. Med.
  Celje, Slovenia Recruiting
• MEDICOINTERNA, medicinske storitve in svetovanje, d.o.o.
  Kočevje, Slovenia Recruiting
• Zdravstveni Dom Koper Casa Della Sanita Capodistria
  Koper, Slovenia Recruiting
• VELOG Zdravstveni center d.o.o.
  Kranj, Slovenia Recruiting

Study contacts

• Study coordinator: Mojca Pernek Miložič, MPharm
• Email: m.pernek@chiesi.com
• Phone: +38640292828

Similar studies

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

• Chronic Respiratory Disease Participant Engagement

  This study tests whether adults with long-term lung conditions can get comfortable with a clinical trials unit and research team before joining future trials.

  Recruiting Richmond Pharmacology Limited · London · NCT07924462

• HB0056 in adults with moderate to severe asthma

  This study tests HB0056 versus a placebo to see if it helps adults with moderate to severe asthma reduce rescue inhaler use and improve symptoms.

  Recruiting at 2 sites Phase 1/2 Shanghai Huaota Biopharmaceutical Co., Ltd. · Beijing and 1 other locations · NCT07899996

• Tilrekimig (PF-07275315) for Severe Asthma: Aimed at Adults with Frequent Exacerbations

  This study tests whether tilrekimig helps people with severe asthma who have had multiple flare-ups in the past year, by comparing it to a placebo given every four weeks.

  Recruiting at 4 sites Phase 3 Pfizer · River Forest, Illinois and 11 other locations · NCT07869043

• Inhaled CHF10136 safety and pharmacokinetics in healthy adults and adults with asthma

  This first-in-human study tests inhaled CHF10136 to see if it is safe and well tolerated, how it behaves in the body, and how it affects adults with asthma compared with placebo.

  Recruiting Phase 1 Chiesi Farmaceutici S.p.A. · Leeds and 2 other locations · NCT07851623

• Biologics for Type 2 Inflammation in Asthma and COPD in Real World

  This real-world study tests whether six biologic drugs can reduce flare-ups and improve symptoms in adults with asthma or COPD treated in routine care in China.

  Recruiting Shanghai Pulmonary Hospital, Shanghai, China · Shanghai, Shanghai Municipality · NCT07823842

• GSK5784283 vs placebo in uncontrolled asthma (PERSIST ASTHMA-2)

  A new medicine called GSK5784283 is being tested to see if it lowers asthma flare-ups better than a placebo in people with uncontrolled asthma.

  Recruiting at 7 sites Phase 3 GlaxoSmithKline · San Diego, California and 6 other locations · NCT07782996

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.