ABSTRACT
Background Current recommendations suggest oxygen (O2) supplementation in patients with pulmonary hypertension (PH). The effect of long-term O2 administration is though merely investigated among these patients. Thus, the aim of this study is to investigate the effect of long term O2 treatment in patients with pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH) on exercise capacity, clinical parameters and hemodynamics. Methods In this prospective, randomized, controlled trial, 20 patients with PAH or CTEPH under stable PH therapy experiencing O2 desaturations at rest and/or during physical activity will be randomised to receive O2 or standard of care (SoC) for 12 weeks. To patients receiving SoC, O2 therapy will be offered after 12 weeks (cross over design). The primary endpoint is the change of the distance walked in 6 minutes after 12 weeks of treatment. Secondary endpoints include change in clinical parameters and hemodynamics. Results Overall 20 patients (O2 n = 10 vs. SoC n = 10) have already been randomized and 15 have completed the study. Two patients died, one patient due to SARS-CoV2 pneumonia in the oxygen arm and one due to right heart failure in the SoC arm. The O2 therapy is so far well tolerated by all patients. Further results are expected in due course. The study is expected to be completed by the end of December 2022. Conclusion Oxygen therapy is well tolerated. Further results are expected soon. The effect of long-term oxygen supplementation should be furtherly investigated in larger controlled-trials.
ABSTRACT
Background: Treprostinil is a prostacyclin analogue which has been approved in the EU for intravenous (i.v.) and subcutaneous (SC) administration in patients with PAH. LIQ861 is a dry powder formulation of treprostinil which can be used for inhalation via a handheld device. Objectives and methods: LTI-201 was a multicentre, Phase 2, open-label, dose-escalation study to evaluate the HD dose-response and safety of LIQ861, followed by an open-label extension period. In "Part A" HD response was measured by right heart catheterization for 120 minutes after a single 26.5 or 53 mug dose of LIQ861. In "Part B" patients were titrated to symptomatic relief (<=159 mug QID) and were reassessed after 16 weeks using right heart catheterization and clinical assessments. Result(s): Fifteen PAH Patients (60 % female, mean age 56 +/- 14.3 years, mean pulmonary vascular resistance (PVR) 605+/-246 dynes/sec/cm-5) were included. In Part A HD measures (PVR and mean pulmonary arterial pressure) improved with a peak response after 15 minutes for both doses. The study was stopped early due to the COVID19 pandemic with only 6 patients completing Part B. At Week 16, these HD responses also improved and clinical assessments improved or remained stable for these patients. All doses of LIQ861 were generally well-tolerated with only one serious adverse event (short episode of hypoxia after inhalation). The most frequently reported adverse events were cough and throat irritation and most were assessed as mild in severity. Conclusion(s): LIQ861 was overall safe and well tolerated. An expected improvement in HD measures was seen with acute and chronic dosing.
ABSTRACT
Current recommendations suggest oxygen (O2) supplementation in patients with pulmonary hypertension (PH). The effect of long-term O2 administration has not been investigated much among these patients. Thus, the aim of this study is to investigate the effect of long term O2- treatment in patients with pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH) on exercise capacity, clinical parameters and hemodynamics. In this prospective, randomized, controlled trial, 20 patients with PAH or CTEPH under stable PH therapy experiencing oxygen desaturations at rest and/or during physical activity will be randomized to receive oxygen or standard of care (SoC) for 12 weeks. To patients receiving SoC, O2 therapy will be offered after 12 weeks (cross-over design). The primary endpoint is the change in the distance walked in 6min after 12 weeks of treatment. Secondary endpoints include change in clinical parameters and hemodynamics. Overall, 20 patients (O2 n=10 vs. SoC n=10) are planned to participate. So far, 12 patients have already been randomized and nine have completed the study. Two patients died, one patient owing to SARS-CoV2 pneumonia in the oxygen arm and one owing to right heart failure in the SoC arm. So far, the O2 therapy is being well tolerated by all patients. Further results are expected in due course. The study is expected to complete recruitment by the end of September 2022. Oxygen therapy is well tolerated. Further results are expected soon. The effect of long-term oxygen supplementation should be investigated further in larger controlled trials.