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

Chiesi

Status: Completed

Conditions: COPD

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT05743608

CHMED_2022/01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,336 patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,336 participants in 1 patient group

Moderate to severe COPD patients receiving Trimbow dry powder inhaler

Description:

Patients 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)