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Real-world test of triple-therapy asthma inhaler begins

NCT ID NCT07489911

Disease control Sponsor: Chiesi Slovenija, d.o.o. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows 200 adults with uncontrolled asthma to see if the Trimbow inhaler (a triple-combination drug) improves symptom control over 6 months. Participants take the inhaler as part of their normal care, and researchers measure changes in asthma control scores and medication adherence. The goal is to understand how well this therapy works outside of strict clinical trials.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Trimbow (beclometasone, formoterol, glycopyrronium) inhaler
What this could lead to
If successful, this study could show that Trimbow improves asthma control in everyday settings, not just in controlled trials.
What could go wrong
This is an observational study, not a randomized trial, so results may be less reliable. It is also relatively small (200 people) and short (6 months).

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

asthma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Asthma Asthma bronchiale Asthma patients

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    18 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • ALVEOLA internistični ambulantni diagnostični center d.o.o.

    RECRUITING

    Maribor, 2000, Slovenia

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

    RECRUITING

    Celje, 3000, Slovenia

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

    RECRUITING

    Ljubljana, 1000, Slovenia

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

    RECRUITING

    Šentjur pri Celju, 3230, Slovenia

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

    RECRUITING

    Celje, 3000, Slovenia

  • EUPNEA d.o.o.

    RECRUITING

    Murska Sobota, Slovenia

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

    RECRUITING

    Celje, 3000, Slovenia

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

    RECRUITING

    Ljubljana, 1000, Slovenia

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

    RECRUITING

    Ljubljana, 1000, Slovenia

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

    RECRUITING

    Kočevje, 1330, Slovenia

  • OBJEM ZDRAVJA zdravstveno svetovalni center d.o.o.

    RECRUITING

    Ljubljana, 1000, Slovenia

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

    RECRUITING

    Ljubljana, 1000, Slovenia

  • VELOG Zdravstveni center d.o.o.

    RECRUITING

    Kranj, Slovenia

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

    RECRUITING

    Murska Sobota, 9000, Slovenia

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

    RECRUITING

    Portorož, 6320, Slovenia

  • Zdravstveni Dom Koper Casa Della Sanita Capodistria

    RECRUITING

    Koper, 6000, Slovenia

  • Zdravstveni Dom Tolmin

    RECRUITING

    Tolmin, 5220, Slovenia

  • Zdravstveni Zavod Pulmoradix Velenje

    RECRUITING

    Velenje, 3320, Slovenia

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