Clinical trial NCT05743608: NEXThaleR Real-world Study Assessing the EffectivenesS of BDP/FF/G Fixed triPle cOmbiNation on Symptom scorEs in COPD Patients
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Keywords: COPD
CAT
Fixed-dose triple inhaled therapy
Lead sponsor: Chiesi Hungary Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Chiesi Slovenija, d.o.o.
name: Chiesi Bulgaria
name: CHIESI CZ s.r.o.
First posted: 2023-02-24
Enrollment: 1336
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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 assessed according to routine clinica practice, without any additional intervention.

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.

Eligibility criteria: 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

Primary outcomes:
measure: COPD Assessment Test (CAT)
timeFrame: 6 months
Secondary outcomes:
measure: Lung function - Forces Expiratory flow in 1 second (FEV1)
timeFrame: 6 months
measure: Lung function Forced Vital Capacity (FVC)
timeFrame: 6 months
measure: Responders
timeFrame: 6 months
measure: Health Related Quality of Life (HRQoL) - questions
timeFrame: 6 months
measure: HRQoL - VAS
timeFrame: 6 months
measure: Symptoms
timeFrame: 6 months
measure: Saturation
timeFrame: 6 months
measure: Adherence
timeFrame: 6 months
measure: Night-time symptoms
timeFrame: 6 months
measure: mMRC
timeFrame: 6 months
Other outcomes:
Locations:
city: Aszód
country: Hungary
facility: Albert Schweitzer Kórház és Rendelőintézet Tüdőbeteggondozó
city: Baja
country: Hungary
facility: Bajai Szent Rókus Kórház, Tüdőbeteggondozó Intézet
city: Budapest
country: Hungary
facility: National Korányi Institute of Pulmonology
city: Budapest
country: Hungary
facility: Bajcsy -Zsilinszky Kórház és Rendelőintézet
city: Budapest
country: Hungary
facility: Józsefvárosi Szent Kozma Egészségügyi Központ Tüdőgyógyászat és Gondozó
city: Budapest
country: Hungary
facility: Kispesti Egészségügyi Intézet Tüdőgondozó, Ernyőképszűrő állomás
city: Budapest
country: Hungary
facility: Szent Kristóf Szakrendelő Tüdőgondozó
city: Cegléd
country: Hungary
facility: Toldy Ferenc Kórház és Rendelőintézet I. Tüdőgondozó
city: Csorna
country: Hungary
facility: Csornai Margit Kórház Tüdőbeteggondozó Intézet
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Központ, Kenézy Gyula Campus Pulmonológiai részleg
city: Dombóvár
country: Hungary
facility: Dombóvári Szent Lukács Kórház, Tüdőbeteggondozó, Dombóvár I.
city: Dorog
country: Hungary
facility: Dorogi Szent Borbála Szakkórház és Szakorvosi Rendelő
city: Dunaújváros
country: Hungary
facility: Szent Pantaleon Kórház Rendelőintézet Dunaújváros
city: Esztergom
country: Hungary
facility: Vaszary Kolos Kórház Tüdőgondozó Esztergom
city: Gyula
country: Hungary
facility: Békés Megyei Központi Kórház 1. Tüdőgyógyászat Szakrendelés
city: Gyöngyös
country: Hungary
facility: Bugát Pál Kórház Tüdőbeteg Gondozó Intézet
city: Jászberény
country: Hungary
facility: Jászberényi Szent Erzsébet Kórház Tüdőgyógyászat Járóbeteg ellátás
city: Kapuvár
country: Hungary
facility: Lumniczer Sándor Kórház-Rendelőintézet Tüdőgondozó
city: Karcag
country: Hungary
facility: Kátai Gábor Kórház Tüdőgyógyászati Szakrendelés
city: Kecskemét
country: Hungary
facility: Bács-Kiskun Megyei Kórház Tüdőgondozó Szakrendelés
city: Keszthely
country: Hungary
facility: Keszthelyi Kórház Tüdőgondozó
city: Kisvárda
country: Hungary
facility: Szent Damján Görögkatolikus Kórház Tüdőgyógyászati gondozó 1.
city: Komárom
country: Hungary
facility: Selye János Kórház Tüdőgyógyászati Szakellátás
city: Kunszentmárton
country: Hungary
facility: Kunszentmárton Városi Egészségügyi Központ Tüdőgyógyászat
city: Marcali
country: Hungary
facility: Szaplonczay Manó Marcali Kórház, Tüdőgyógyászati Szakrendelés
city: Mohács
country: Hungary
facility: Mohácsi Kórház, Tüdőbeteggondozó
city: Mosonmagyaróvár
country: Hungary
facility: Karolina Kórház-Rendelőintézet Mosonmagyaróvár
city: Nagyatád
country: Hungary
facility: Nagyatádi Kórház Tüdőgondozó
city: Nyíregyháza
country: Hungary
facility: FM Magánklinika Eü. Szolg. Kft.
city: Nyíregyháza
country: Hungary
facility: Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház
city: Orosháza
country: Hungary
facility: Orosházi Kórház Tüdőgondozó
city: Oroszlány
country: Hungary
facility: Oroszlányi Szakorvosi és Ápolási Intézet Tüdőgyógyászat
city: Pécs
country: Hungary
facility: Egyesített Egészségügyi Intézmények, Tüdőgondozó
city: Salgótarján
country: Hungary
facility: Szent Lázár Megyei Kórház, Tüdőbeteggondozó Szakrendelő
city: Sarkad
country: Hungary
facility: Sarkadi Kistérségi Egészségügyi Fejlesztő Nonprofit Kft.
city: Szeghalom
country: Hungary
facility: Békés Megyei Képviselő-testület Pándy Kálmán Kórháza Tüdőgondozó
city: Szolnok
country: Hungary
facility: Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Rendelőintézet Tüdőgyógyászati Szakrendelés
city: Szombathely
country: Hungary
facility: Markusovszky Egyetemi Oktatókorház
city: Zalaegerszeg
country: Hungary
facility: Zala Megyei Szent Rafael Kórház Pulmonológia, Allergológiai és Asztma Szakrendelés
Study officials:
References: