NEXThaleR Real-world Study Assessing the EffectivenesS of BDP/FF/G Fixed triPle cOmbiNation on Symptom scorEs in COPD Patients
- Conditions
- COPD
- Registration Number
- NCT05743608
- Lead Sponsor
- Chiesi Hungary Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
<br><br> - Patient had been diagnosed with COPD for over a year by a pulmonologists specialist<br><br> - Patients = 35 years of age<br><br> - outpatient<br><br> - Having had a spirometry test performed maximum 1 month prior to inclusion OR on the<br> day of study inclusion<br><br> - Eligibility to Trimbow 88/5/9 µg inhalation powder treatment according to SmPC:<br><br> - having a moderate or severe obstruction (30%=FEV1<80%)<br><br> - uncontrolled despite fixed dual combination treatment (LABA/LAMA or ICS/LABA):<br><br> - at least 1 severe or 2 moderate exacerbations (requiring hospital<br> admission) in the past 12 months<br><br> - symptomatic patient (CAT=10 and/or mMRC =2)<br><br> - Therapy was changed to Trimbow® 88/5/9 µg inhalation powder maximum 1 week prior to<br> or on the day of study inclusion and irrespective of study entry (escalation of<br> symptomatic patient to fixed triple combination as per treatment protocol)<br><br> - Patient provided informed consent to study participation and related data collected<br><br> - Patient with no functional disability<br><br>Exclusion criteria:<br><br> - Participation in any clinical trial, 30 days prior to inclusion<br><br> - Ongoing severe exacerbation (requiring hospitalisation) or severe exacerbation<br> within the last 4 weeks<br><br> - Diagnosis of asthma (asthma/COPD co-occurrence - ACO not allowed!)<br><br> - Continuous use of oral corticosteroids or oxygen therapy<br><br> - Patients with other important diseases of the respiratory system or other organ<br> systems that may significantly contribute to COPD symptoms (such as untreated heart<br> failure, symptomatic anaemia, etc.)<br><br> - Any additional contraindications listed in the SmPC for Trimbow® 88/5/9 µg<br> inhalation powder and any other provision in the SmPC that would prevent the patient<br> from receiving fixed triple combination therapy<br><br> - The patient is unable to complete the part of the questionnaire(s) relevant to<br> him/her
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method COPD Assessment Test (CAT)
- Secondary Outcome Measures
Name Time Method Lung function - Forces Expiratory flow in 1 second (FEV1);Lung function Forced Vital Capacity (FVC);Responders;Health Related Quality of Life (HRQoL) - questions;HRQoL - VAS;Symptoms;Saturation;Adherence;Night-time symptoms;mMRC