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

Prior treatment

• Participation in any clinical trial, 30 days prior to inclusion
• Continuous use of oral corticosteroids or oxygen therapy
• 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

Other illness

• 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.)

Other

• Ongoing severe exacerbation (requiring hospitalisation) or severe exacerbation within the last 4 weeks
• Diagnosis of asthma (asthma/COPD co-occurrence - ACO not allowed!)
• The patient is unable to complete the part of the questionnaire(s) relevant to him/her

• 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