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COPDRESPONSENCT05743608

NEXThaleR Real-world Study Assessing the EffectivenesS of BDP/FF/G Fixed triPle cOmbiNation on Symptom scorEs in COPD Patients

An observational study of COPD, run by Chiesi Hungary Ltd. at 39 sites in Hungary.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this observational study is to measure improvement in health related quality of life in moderate to severe COPD patients treated with Trimbow inhalation powder. The main question[s] it aims to answer are: Treatment's effect on quality of life Treatment's effect on lung function Participants will be… Read more about this study

Who is it for?
Ages 35 years and older
Conditions the study is for
COPD
How many people
1,336 participants
Where
39 sitesHungary
Study dates
29 Mar 2023to 5 May 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 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

Who may be able to join

  • 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%)
Show all 12Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

39 sites in 1 country.

39 sites in 1 country

Hungary39 sites

  • Albert Schweitzer Kórház és Rendelőintézet Tüdőbeteggondozó

    Aszód

  • Bajai Szent Rókus Kórház, Tüdőbeteggondozó Intézet

    Baja

  • National Korányi Institute of Pulmonology

    Budapest, 1122

  • Bajcsy -Zsilinszky Kórház és Rendelőintézet

    Budapest

  • Józsefvárosi Szent Kozma Egészségügyi Központ Tüdőgyógyászat és Gondozó

    Budapest

  • Kispesti Egészségügyi Intézet Tüdőgondozó, Ernyőképszűrő állomás

    Budapest

  • Szent Kristóf Szakrendelő Tüdőgondozó

    Budapest

  • Toldy Ferenc Kórház és Rendelőintézet I. Tüdőgondozó

    Cegléd

  • Csornai Margit Kórház Tüdőbeteggondozó Intézet

    Csorna

  • Debreceni Egyetem Klinikai Központ, Kenézy Gyula Campus Pulmonológiai részleg

    Debrecen

  • Dombóvári Szent Lukács Kórház, Tüdőbeteggondozó, Dombóvár I.

    Dombóvár

  • Dorogi Szent Borbála Szakkórház és Szakorvosi Rendelő

    Dorog

  • Szent Pantaleon Kórház Rendelőintézet Dunaújváros

    Dunaújváros

  • Vaszary Kolos Kórház Tüdőgondozó Esztergom

    Esztergom

  • Bugát Pál Kórház Tüdőbeteg Gondozó Intézet

    Gyöngyös

  • Békés Megyei Központi Kórház 1. Tüdőgyógyászat Szakrendelés

    Gyula

  • Jászberényi Szent Erzsébet Kórház Tüdőgyógyászat Járóbeteg ellátás

    Jászberény

  • Lumniczer Sándor Kórház-Rendelőintézet Tüdőgondozó

    Kapuvár

  • Kátai Gábor Kórház Tüdőgyógyászati Szakrendelés

    Karcag

  • Bács-Kiskun Megyei Kórház Tüdőgondozó Szakrendelés

    Kecskemét

  • Keszthelyi Kórház Tüdőgondozó

    Keszthely

  • Szent Damján Görögkatolikus Kórház Tüdőgyógyászati gondozó 1.

    Kisvárda

  • Selye János Kórház Tüdőgyógyászati Szakellátás

    Komárom

  • Kunszentmárton Városi Egészségügyi Központ Tüdőgyógyászat

    Kunszentmárton

  • Szaplonczay Manó Marcali Kórház, Tüdőgyógyászati Szakrendelés

    Marcali

  • Mohácsi Kórház, Tüdőbeteggondozó

    Mohács

  • Karolina Kórház-Rendelőintézet Mosonmagyaróvár

    Mosonmagyaróvár

  • Nagyatádi Kórház Tüdőgondozó

    Nagyatád

  • FM Magánklinika Eü. Szolg. Kft.

    Nyíregyháza

  • Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház

    Nyíregyháza

  • Orosházi Kórház Tüdőgondozó

    Orosháza

  • Oroszlányi Szakorvosi és Ápolási Intézet Tüdőgyógyászat

    Oroszlány

  • Egyesített Egészségügyi Intézmények, Tüdőgondozó

    Pécs

  • Szent Lázár Megyei Kórház, Tüdőbeteggondozó Szakrendelő

    Salgótarján

  • Sarkadi Kistérségi Egészségügyi Fejlesztő Nonprofit Kft.

    Sarkad

  • Békés Megyei Képviselő-testület Pándy Kálmán Kórháza Tüdőgondozó

    Szeghalom

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

    Szolnok

  • Markusovszky Egyetemi Oktatókorház

    Szombathely

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

    Zalaegerszeg

Other trials in Hungary

About this study

Official title: Non-interventional, Open-label, Prospective Study to Assess the Effectiveness of BDP/FF/G Fixed Triple Inhalation Powder on Symptom Scores in Moderate to Severe COPD Patients, Uncontrolled With Inhaled Dual Therapies (LABA/LAMA or ICS/LABA)

The goal of this observational study is to measure improvement in health related quality of life in moderate to severe COPD patients treated with Trimbow inhalation powder. The main question[s] it aims to answer are:

  • Treatment's effect on quality of life
  • Treatment's effect on lung function Participants will be assessed according to routine clinica practice, without any additional intervention.
Read the detailed description

COPD is a severe and very common disease affecting a large proportion of smokers (and even non-smokers) all around the world. With the large prevalence and wide spectrum of disease presentation (from limited obstruction to life threatening conditions) there is a need for differentiated, targeted approach to therapy. For this purpose, plenty of inhaler devices had been developed. Chiesi is the only company which provides fix triple combinations in both DPI and pMDI formulations. While there is ample data from multiple studies on the real-world effectiveness of the pMDI, there is a relevant gap in our knowledge on the RWE effectiveness of the DPI device Trimbow dry powder inhaler is a novel extrafine, single inhaler triple therapy, in a state of the art dry powder inhaler, which is easy to use and may provide additional benefit to a large proportion of COPD patients. However, there are only a limited number of studies assessing its effectiveness, especially in patients with moderate airflow obstruction. Providing more real-world evidence that Trimbow® dry powder inhaler is an effective and preferred treatment option in reducing symptoms and improving lung function in all COPD patients, would help pulmonologists choose the most suitable treatment option for a very wide array of patients.

Conditions
COPD
Keywords
COPD, CAT, Fixed-dose triple inhaled therapy
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05743608
Study groupRoleWhat they receive
Moderate to severe COPD patients receiving Trimbow dry powder inhalerPatients above the age of 35 years, who had been diagnosed with COPD for over a year by a pulmonologists specialist. Having a moderate or severe obstruction (30%≤FEV1<80%) and are uncontrolled despite fixed dual combination treatment (LABA/LAMA or ICS/LABA). 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)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. COPD Assessment Test (CAT)

    Change in symptom scores (COPD Assessment Test - CAT) after six months of treatment. On a scale of 0-40

    Measured: 6 months

Secondary outcomes (10)

  1. Lung function - Forces Expiratory flow in 1 second (FEV1)

    Change in FEV1 values after inhalation during 6 months of treatment compared to baseline.

    Measured: 6 months

  2. Lung function Forced Vital Capacity (FVC)

    Change in FVC values after inhalation during 6 months of treatment compared to baseline.

    Measured: 6 months

  3. Responders

    Percentage of patients with a change from baseline 2< in CAT after 6 months of treatment compared to baseline (assessment of response to therapy).

    Measured: 6 months

  4. Health Related Quality of Life (HRQoL) - questions

    To assess changes in quality of life in EQ-5D-3L domains after 6 months of treatment compared to baseline. Scale on a level of three

    Measured: 6 months

  5. HRQoL - VAS

    To assess changes in quality of life in EQ-5D visual analogue scale (VAS) after 6 months of treatment compared to baseline. Scale from 0-100

    Measured: 6 months

  6. Symptoms

    To assess changes in frequency of cough and sputum production after 6 months of treatment compared to baseline.

    Measured: 6 months

  7. Saturation

    To assess changes in arterial oxygenation compared to baseline oxigen saturation (SpO2) after 6 months of treatment.

    Measured: 6 months

  8. Adherence

    To assess changes in adherence to inhaler treatment according to the TAI (Test of adherence to inhalers) questionnaire after 6 months of treatment compared to baseline. Scale is from 12-54

    Measured: 6 months

  9. Night-time symptoms

    To assess changes in the frequency of night-time symptoms after 6 months of treatment compared to baseline.

    Measured: 6 months

  10. mMRC

    To assess changes in dyspnoea severity using the mMRC (modified Medical Research Council) questionnaire after 6 months of treatment compared to baseline. Scale from 1-4

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2023
  2. Study start29 Mar 2023
  3. Primary completion31 Oct 2024
  4. Study completion5 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,336 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05743608
Sponsor's protocol ID
CHMED_2022/01
Acronym
RESPONSE
Status last verified
Sep 2025
First submitted
15 Feb 2023
Last updated
9 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of COPD, run by Chiesi Hungary Ltd. at 39 sites in Hungary.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

COPD Assessment Test (CAT) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05743608.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.

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