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

COPD Clinical Trial

— RESPONSE  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05743608
• Other study ID #: CHMED_2022/01
• Status: Recruiting
• Start date: March 29, 2023
• Est. completion date: August 31, 2024

Study information

• Verified date: June 2023
• Source: Chiesi Hungary Ltd.
• Contact: András Keglevich, PhD
• Phone: +36309788085
• Email: a.keglevich[@]chiesi.com
• Is FDA regulated: No
• Study type: Observational

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: August 31, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD

Locations

Country	Name	City	State
Hungary	Albert Schweitzer Kórház és Rendelointézet Tüdobeteggondozó	Aszód
Hungary	Bajai Szent Rókus Kórház, Tüdobeteggondozó Intézet	Baja
Hungary	Bajcsy -Zsilinszky Kórház és Rendelointézet	Budapest
Hungary	Józsefvárosi Szent Kozma Egészségügyi Központ Tüdogyógyászat és Gondozó	Budapest
Hungary	Kispesti Egészségügyi Intézet Tüdogondozó, Ernyoképszuro állomás	Budapest
Hungary	National Korányi Institute of Pulmonology	Budapest
Hungary	Szent Kristóf Szakrendelo Tüdogondozó	Budapest
Hungary	Toldy Ferenc Kórház és Rendelointézet I. Tüdogondozó	Cegléd
Hungary	Csornai Margit Kórház Tüdobeteggondozó Intézet	Csorna
Hungary	Debreceni Egyetem Klinikai Központ, Kenézy Gyula Campus Pulmonológiai részleg	Debrecen
Hungary	Dombóvári Szent Lukács Kórház, Tüdobeteggondozó, Dombóvár I.	Dombóvár
Hungary	Dorogi Szent Borbála Szakkórház és Szakorvosi Rendelo	Dorog
Hungary	Szent Pantaleon Kórház Rendelointézet Dunaújváros	Dunaújváros
Hungary	Vaszary Kolos Kórház Tüdogondozó Esztergom	Esztergom
Hungary	Bugát Pál Kórház Tüdobeteg Gondozó Intézet	Gyöngyös
Hungary	Békés Megyei Központi Kórház 1. Tüdogyógyászat Szakrendelés	Gyula
Hungary	Jászberényi Szent Erzsébet Kórház Tüdogyógyászat Járóbeteg ellátás	Jászberény
Hungary	Lumniczer Sándor Kórház-Rendelointézet Tüdogondozó	Kapuvár
Hungary	Kátai Gábor Kórház Tüdogyógyászati Szakrendelés	Karcag
Hungary	Bács-Kiskun Megyei Kórház Tüdogondozó Szakrendelés	Kecskemét
Hungary	Keszthelyi Kórház Tüdogondozó	Keszthely
Hungary	Szent Damján Görögkatolikus Kórház Tüdogyógyászati gondozó 1.	Kisvárda
Hungary	Selye János Kórház Tüdogyógyászati Szakellátás	Komárom
Hungary	Kunszentmárton Városi Egészségügyi Központ Tüdogyógyászat	Kunszentmárton
Hungary	Szaplonczay Manó Marcali Kórház, Tüdogyógyászati Szakrendelés	Marcali
Hungary	Mohácsi Kórház, Tüdobeteggondozó	Mohács
Hungary	Karolina Kórház-Rendelointézet Mosonmagyaróvár	Mosonmagyaróvár
Hungary	Nagyatádi Kórház Tüdogondozó	Nagyatád
Hungary	FM Magánklinika Eü. Szolg. Kft.	Nyíregyháza
Hungary	Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház	Nyíregyháza
Hungary	Orosházi Kórház Tüdogondozó	Orosháza
Hungary	Oroszlányi Szakorvosi és Ápolási Intézet Tüdogyógyászat	Oroszlány
Hungary	Egyesített Egészségügyi Intézmények, Tüdogondozó	Pécs
Hungary	Szent Lázár Megyei Kórház, Tüdobeteggondozó Szakrendelo	Salgótarján
Hungary	Sarkadi Kistérségi Egészségügyi Fejleszto Nonprofit Kft.	Sarkad
Hungary	Békés Megyei Képviselo-testület Pándy Kálmán Kórháza Tüdogondozó	Szeghalom
Hungary	Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Rendelointézet Tüdogyógyászati Szakrendelés	Szolnok
Hungary	Markusovszky Egyetemi Oktatókorház	Szombathely
Hungary	Zala Megyei Szent Rafael Kórház Pulmonológia, Allergológiai és Asztma Szakrendelés	Zalaegerszeg

Sponsors (4)

Lead Sponsor	Collaborator
Chiesi Hungary Ltd.	CHIESI Bulgaria Ltd., CHIESI CZ s.r.o., Chiesi Slovenija, d.o.o.

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	COPD Assessment Test (CAT)	Change in symptom scores (COPD Assessment Test - CAT) after six months of treatment. On a scale of 0-40	6 months
Secondary	Lung function - Forces Expiratory flow in 1 second (FEV1)	Change in FEV1 values after inhalation during 6 months of treatment compared to baseline.	6 months
Secondary	Lung function Forced Vital Capacity (FVC)	Change in FVC values after inhalation during 6 months of treatment compared to baseline.	6 months
Secondary	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).	6 months
Secondary	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	6 months
Secondary	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	6 months
Secondary	Symptoms	To assess changes in frequency of cough and sputum production after 6 months of treatment compared to baseline.	6 months
Secondary	Saturation	To assess changes in arterial oxygenation compared to baseline oxigen saturation (SpO2) after 6 months of treatment.	6 months
Secondary	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	6 months
Secondary	Night-time symptoms	To assess changes in the frequency of night-time symptoms after 6 months of treatment compared to baseline.	6 months
Secondary	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	6 months