Randomised, controlled crossover trial to evaluate the Effects of Ambulatory Oxygen on health status in patients with Fibrotic Lung Disease (FLD)

Royal Brompton and Harefield NHS Foundation Trust (RB&HFT)0 个研究点目标入组 80 人开始时间: 2016年3月22日最近更新: 2019年1月14日

适应症

试验速览

•1.Patients with a diagnosis of idiopathic pulmonary fibrosis (IPF), or with another fibrotic ILD
•2. Aged between 18 and 99 years
•3. Patients whose oxygen saturation (SaO2) at rest on room air is =94% and falls<88% on a baseline 6MWT (performed as part of their routine assessment)
•4. Patients with stable symptoms and treatment during the period of four weeks prior to being recruited into the study, including the two week run in period

•1.Patients expected to change treatment over the time course of the study, and those meeting criteria for long term oxygen therapy, i.e. hypoxic at rest
•2.Patients with connective tissue disease-associated ILD or with sarcoidosis with musculoskeletal/joint involvement/symptoms will be excluded due to the potential impact in relation to day-to-day mobility
•3.Patients with significant communication or other locomotor difficulties, and/or severe co-morbidities
•4.Current smokers in view of the potential risks associated with use of supplemental oxygen
•5.Pregnancy
•6.History of symptomatic ischaemic cardiac disease (exertion-induced chest pain)
•7.Anaemia, Hb<10g/dl

发起方

Royal Brompton and Harefield NHS Foundation Trust (RB&HFT)