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

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 theday 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 hospitaladmission) 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 toor on the day of study inclusion and irrespective of study entry (escalation ofsymptomatic 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 exacerbationwithin 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 organsystems that may significantly contribute to COPD symptoms (such as untreated heartfailure, symptomatic anaemia, etc.)

• Any additional contraindications listed in the SmPC for Trimbow® 88/5/9 µginhalation powder and any other provision in the SmPC that would prevent the patientfrom receiving fixed triple combination therapy

• The patient is unable to complete the part of the questionnaire(s) relevant tohim/her