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Trimbow shows promise for COPD patients not helped by other inhalers

NCT ID NCT05743608

Disease control Sponsor: Chiesi Hungary Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study followed over 1,300 people with moderate to severe COPD whose symptoms were not controlled by standard dual inhalers. Researchers measured how Trimbow, a triple-combination inhaler, affected their quality of life and lung function over six months. The goal was to see if switching to Trimbow leads to real-world improvements in breathing and daily activities.

What this could mean

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

Active substance
Trimbow (budesonide/glycopyrronium/formoterol fumarate) inhalation powder
What this could lead to
If successful, this study could confirm that Trimbow helps people with COPD feel better and breathe easier in everyday life.
What could go wrong
This is an observational study, not a controlled trial, so results may be less reliable. It also only measures short-term effects over six 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

1,336 people

The number who actually took part.

Started

Mar 2023

Finished

May 2025

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

Moderate to severe COPD patients who are uncontrolled on either LABA/LAMA or ICS/LABA fixed dose dual combination therapy, and had been switched to Trimbow dry powder inhaler prior to study inclusion

Ages

35 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: * Patient had been diagnosed with COPD for over a year by a pulmonologists specialist * Patients ≥ 35 years of age * outpatient * Having had a spirometry test performed maximum 1 month prior to inclusion OR on the day of study inclusion * Eligibility to Trimbow 88/5/9 µg inhalation powder treatment according to SmPC: * having a moderate or severe obstruction (30%≤FEV1\<80%) * uncontrolled despite fixed dual combination treatment (LABA/LAMA or ICS/LABA): * at least 1 severe or 2 moderate exacerbations (requiring hospital admission) in the past 12 months * symptomatic patient (CAT≥10 and/or mMRC ≥2) * Therapy was changed to Trimbow® 88/5/9 µg inhalation powder maximum 1 week prior to or on the day of study inclusion and irrespective of study entry (escalation of symptomatic patient to fixed triple combination as per treatment protocol) * Patient provided informed consent to study participation and related data collected * Patient with no functional disability Exclusion criteria: * Participation in any clinical trial, 30 days prior to inclusion * Ongoing severe exacerbation (requiring hospitalisation) or severe exacerbation within the last 4 weeks * Diagnosis of asthma (asthma/COPD co-occurrence - ACO not allowed!) * Continuous use of oral corticosteroids or oxygen therapy * Patients with other important diseases of the respiratory system or other organ systems that may significantly contribute to COPD symptoms (such as untreated heart failure, symptomatic anaemia, etc.) * Any additional contraindications listed in the SmPC for Trimbow® 88/5/9 µg inhalation powder and any other provision in the SmPC that would prevent the patient from receiving fixed triple combination therapy * The patient is unable to complete the part of the questionnaire(s) relevant to him/her

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Conditions

The condition(s) this trial relates to.

chronic obstructive pulmonary disease COPD, severe early onset

As listed by the trial registrant

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

COPD

Contacts and locations

Locations

  • Albert Schweitzer Kórház és Rendelőintézet Tüdőbeteggondozó

    Aszód, Hungary

  • Bajai Szent Rókus Kórház, Tüdőbeteggondozó Intézet

    Baja, Hungary

  • Bajcsy -Zsilinszky Kórház és Rendelőintézet

    Budapest, Hungary

  • Bugát Pál Kórház Tüdőbeteg Gondozó Intézet

    Gyöngyös, Hungary

  • Bács-Kiskun Megyei Kórház Tüdőgondozó Szakrendelés

    Kecskemét, Hungary

  • Békés Megyei Képviselő-testület Pándy Kálmán Kórháza Tüdőgondozó

    Szeghalom, Hungary

  • Békés Megyei Központi Kórház 1. Tüdőgyógyászat Szakrendelés

    Gyula, Hungary

  • Csornai Margit Kórház Tüdőbeteggondozó Intézet

    Csorna, Hungary

  • Debreceni Egyetem Klinikai Központ, Kenézy Gyula Campus Pulmonológiai részleg

    Debrecen, Hungary

  • Dombóvári Szent Lukács Kórház, Tüdőbeteggondozó, Dombóvár I.

    Dombóvár, Hungary

  • Dorogi Szent Borbála Szakkórház és Szakorvosi Rendelő

    Dorog, Hungary

  • Egyesített Egészségügyi Intézmények, Tüdőgondozó

    Pécs, Hungary

  • FM Magánklinika Eü. Szolg. Kft.

    Nyíregyháza, Hungary

  • Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Rendelőintézet Tüdőgyógyászati Szakrendelés

    Szolnok, Hungary

  • Jászberényi Szent Erzsébet Kórház Tüdőgyógyászat Járóbeteg ellátás

    Jászberény, Hungary

  • Józsefvárosi Szent Kozma Egészségügyi Központ Tüdőgyógyászat és Gondozó

    Budapest, Hungary

  • Karolina Kórház-Rendelőintézet Mosonmagyaróvár

    Mosonmagyaróvár, Hungary

  • Keszthelyi Kórház Tüdőgondozó

    Keszthely, Hungary

  • Kispesti Egészségügyi Intézet Tüdőgondozó, Ernyőképszűrő állomás

    Budapest, Hungary

  • Kunszentmárton Városi Egészségügyi Központ Tüdőgyógyászat

    Kunszentmárton, Hungary

  • Kátai Gábor Kórház Tüdőgyógyászati Szakrendelés

    Karcag, Hungary

  • Lumniczer Sándor Kórház-Rendelőintézet Tüdőgondozó

    Kapuvár, Hungary

  • Markusovszky Egyetemi Oktatókorház

    Szombathely, Hungary

  • Mohácsi Kórház, Tüdőbeteggondozó

    Mohács, Hungary

  • Nagyatádi Kórház Tüdőgondozó

    Nagyatád, Hungary

  • National Korányi Institute of Pulmonology

    Budapest, 1122, Hungary

  • Orosházi Kórház Tüdőgondozó

    Orosháza, Hungary

  • Oroszlányi Szakorvosi és Ápolási Intézet Tüdőgyógyászat

    Oroszlány, Hungary

  • Sarkadi Kistérségi Egészségügyi Fejlesztő Nonprofit Kft.

    Sarkad, Hungary

  • Selye János Kórház Tüdőgyógyászati Szakellátás

    Komárom, Hungary

  • Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház

    Nyíregyháza, Hungary

  • Szaplonczay Manó Marcali Kórház, Tüdőgyógyászati Szakrendelés

    Marcali, Hungary

  • Szent Damján Görögkatolikus Kórház Tüdőgyógyászati gondozó 1.

    Kisvárda, Hungary

  • Szent Kristóf Szakrendelő Tüdőgondozó

    Budapest, Hungary

  • Szent Lázár Megyei Kórház, Tüdőbeteggondozó Szakrendelő

    Salgótarján, Hungary

  • Szent Pantaleon Kórház Rendelőintézet Dunaújváros

    Dunaújváros, Hungary

  • Toldy Ferenc Kórház és Rendelőintézet I. Tüdőgondozó

    Cegléd, Hungary

  • Vaszary Kolos Kórház Tüdőgondozó Esztergom

    Esztergom, Hungary

  • Zala Megyei Szent Rafael Kórház Pulmonológia, Allergológiai és Asztma Szakrendelés

    Zalaegerszeg, Hungary

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