J44 J96.1
Conditions
Interventions
Group 1: HFT for at least 8 hours per day. In addition, the patient receives long-term oxygen treatment (LTOT). A total therapy duration of HFT and LTOT together for at least 16 hours per day is recom
Sponsors
Klinik für Pneumologie und Intensivmedizin Uniklinik RWTH Aachen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with stage III/IV COPD according to GOLD 2. Patients receiving long-term oxygen therapy (LTOT) based on a previously diagnosed chronic respiratory insufficiency type I (hypoxemic) or LTOT-naive, hypoxemic patients with an indication for LTOT 3. Existing LTOT for at least 3 months 4. Use of LTOT for at least 8 hours per day in the last 4 weeks prior to study inclusion 5. Guideline-compliant drug treatment of COPD for at least 3 months
Exclusion criteria
Exclusion criteria: 1. Patients with hypercapnia (PaCO2 > 52 mmHg) and/or acute respiratory acidosis (pH < 7.35) 2. Presence of a competing cause of chronic respiratory insufficiency type I (hypoxemic) 3. Patients receiving non-invasive ventilation (NIV), continuous positive airway pressure (CPAP), or automatic positive airway pressure (APAP) 4. Active cancer that may affect the prognosis of the disease 5. Active smoking 6. Anemia (hemoglobin < 8.0 g/dl in a BGA) 7. Severe underlying disease with a life expectancy of < 12 months 8. Planned rehabilitation treatment in the first 3 months of the study 9. Thoracic procedures (endoscopic/surgical) performed within 3 months prior to study entry or pending at the time of study entry 10. Acute exacerbation of COPD at the time of study entry or in the previous 6 weeks 11. Patients with previous treatment with HFT in an outpatient setting 12. Age < 18 years 13. Simultaneous participation in another clinical intervention study 14. At the investigator's discretion, participation in the study poses an unacceptable risk due to a pre-existing or concomitant disease or due to the patient's general condition. 15. The patient is institutionalized due to an administrative or judicial order 16. Unable to give consent without legal guardianship 17. Patients who are dependent on or employed by the Coordinating Investigator (Coord. Inv.) or the Principal Investigator (PI) 18. Patients with private health insurance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary study objective: The primary objective of the study is to demonstrate the efficacy of HFT in addition to LTOT compared to LTOT alone. Primary endpoint: Response to therapy, defined as a combined endpoint consisting of: 1) Tolerability of treatment, defined as study participation and receipt of the randomly assigned treatment for at least 3 months. 2) Improvement of at least 5 points in the Severe Respiratory Insufficiency Questionnaire (SRI) total score at 12 months compared to the score at baseline. Supportive endpoints for the primary study objective: 1) Response to therapy, defined as an improvement of at least 15 points in the SRI total score at 12 months compared to the baseline assessment. 2) Response to therapy, defined as an improvement of at least 5 points in the SRI total score at 3 or 6 months compared to the baseline assessment. 3) Response to treatment defined as an improvement of at least 15 points in the SRI total score at 3 and 6 months, respectively, compared to the assessment at baseline. 4) The change in the SRI total score at 12 months and over time compared to the assessment at baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Cumulative Proportion of Responders Analysis (CPRA) for different thresholds of improvement in SRI total score in both groups at 3, 6 and 12 months • Change from baseline in St. George's Respiratory Questionnaire (SGRQ) at 3, 6 and 12 months • BGA (PaCO2, PaO2, HCO3-, pH) at 3, 6 and 12 months • Difference (metres) in 6-minute walk test (6MWT) at 3, 6 and 12 months • Difference in pulmonary function analysis (FEV1, FVC) after 3, 6, 12 months • Mortality analysis • Exacerbation rate • Hospitalisation rate (COPD-specific and overall) • Time to event mortality, exacerbation • Hospitalisation days • Device compliance (HFT usage time) • Symptom severity of underlying disease (measured using the COPD Assessment Test (CAT) and the modified Medical Research Council (mMRC)) • BODE index • Daytime sleepiness (Epworth Sleepiness Scale (ESS)) • Difference in oxygen uptake with HFT compared to LTOT • Indication for long-term non-invasive ventilation (NIV) • Occurrence of (serious) adverse events • Occurrence of device deficiencies • Vital signs (systolic and diastolic blood pressure, pulse rate, respiratory rate, SpO2) • Laboratory tests • Physical examination (including body weight and height, BMI) • Previous/concomitant medication • Demographic data and baseline characteristics • Smoking habits | — |
Countries
Germany
Contacts
Public ContactMichael Dreher
Klinik für Pneumologie und Intensivmedizin Uniklinik RWTH Aachen
Outcome results
None listed