J44 J96.1
Conditions
Interventions
Group 1: HFT for at least 8 hours per day, mainly during the night. Patients are also encouraged to use HFT when resting and when dyspnoea worsens.
Group 2: Existing NIV therapy. Patients are encourag
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 COPD in stage III/IV according to GOLD 2. Patients with non-invasive ventilation (NIV) based on a previously diagnosed chronic respiratory insufficiency type II (hypercapnic) 3. Existing NIV for at least 3 months; In order to confirm the effective settings of NIV (if necessary after adjustment/optimization of NIV), a blood gas analysis (BGA) must be performed on the day after 15 minutes without O2 and without NIV, as well as in a nighttime BGA after at least 15 minutes of NIV therapy with/without O2. If non-hospital ventilation is monitored on an outpatient basis at a center, the nocturnal BGA with/without O2 is not required and is performed during the day after at least 15 minutes of NIV therapy with/without O2 in accordance with the center's routine. Both BGA measurements must meet the following parameters: • PaCO2 = 60 mmHg AND • pH = 7.35 4. Guideline-compliant drug treatment of COPD for at least 3 months
Exclusion criteria
Exclusion criteria: 1. Duration of NIV therapy 35 kg/m2 4. PEEP/EPAP > 7 cm H2O 5. Presence of a competing cause of chronic respiratory failure type II (hypercapnic), e.g., a neuromuscular or thoracic restrictive disorder 6. Active cancer that may affect the prognosis of the disease 7. Active smoking 8. Anemia (hemoglobin < 8.0 g/dl in a BGA) 9. Severe underlying disease with a life expectancy of < 12 months 10. Planned rehabilitation treatment in the first 3 months of the study 11. Thoracic procedures (endoscopic/surgical) performed within 3 months prior to study entry or pending at the time of study entry 12. Acute exacerbation of COPD at the time of study entry or in the previous 6 weeks 13. Patients with previous treatment with HFT in an outpatient setting 14. Age < 18 years 15. Simultaneous participation in another clinical intervention study 16. 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 17. The patient is institutionalized due to an administrative or court order 18. Unable to give consent without legal guardianship 19. Patients who are dependent on or employed by the Coordinating Investigator (Coord. Inv.) or the Principal Investigator (PI) 20. 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 compared to NIV. Primary endpoint: Response to therapy, defined as a combined endpoint consisting of achieving both of the following: 1) Tolerability of treatment, defined as study participation and receipt of the randomly assigned treatment for at least 3 months AND 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 NIV • 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 ContactWolfram Windisch
Lungenklinik der Kliniken der Stadt Köln gGmbH
Outcome results
None listed