Grant awarded for trial into respiratory disease
Dr Alice Turner, Professor of Respiratory Medicine in the Institute of Applied Health Research, and her team have been successfully awarded a £650,000 NIHR Health Technology Assessment trial grant to test ambulatory oxygen in patients with idiopathic pulmonary fibrosis.
Over three years the 'OxyPuf' trial plans to assess the benefit, if any, of ambulatory oxygen in the management of people with idiopathic pulmonary fibrosis (IPF) by conducting a randomised controlled trial in 260 IPF patients who are breathless on walking.
IPF is a devastating condition of unknown cause that results in progressive, irreversible scarring of the lung (pulmonary fibrosis). IPF has, until recently, been considered to be a rare disease however is thought to be responsible for as many as 1 in 100 deaths in the UK, killing 5,300 people a year (more than cancers such as those of the stomach, liver and skin).
Initially sufferers notice shortness of breath and a persistent dry cough which can be embarrassing as well as impacting on sleep and quality of life. As a result of this symptom reduced physical activity occurs, which may affect basic tasks such as washing, dressing and eating. Loss of appetite, weight loss, fatigue, anxiety and depression add to the already high symptom burden.
Treatment may include exercise (pulmonary rehabilitation) and tablets designed to reduce processes in the lung which lead to scarring (anti-fibrotics). Even with the best available treatments half of patients survive only three years from the time of diagnosis – a prognosis similar to lung cancer Increasing breathlessness can happen as a result of low oxygen levels, especially when trying to be active, although can occur even in the context of normal oxygen levels.
In other respiratory conditions, such as chronic obstructive pulmonary disease, oxygen is used to help relieve symptoms and extend life in selected patients. However, there has been very little research into the management of low oxygen levels in IPF and no evidence as to whether oxygen is beneficial if used just when walking (ambulatory oxygen).
OxyPuf will assess the impact on quality of life, breathlessness and ability to exercise is any better in patients who receive ambulatory oxygen compared to those receiving best supportive care. If OxyPuf demonstrates a benefit, guidelines in the UK are likely to be updated to include oxygen therapy as a routine treatment. Conversely, if it’s not found to be helpful, it would help drive earlier focus on rehabilitation to maintain functional capacity and independence.
Dr Turner said: "I am delighted that Birmingham will lead this trial, whose results could directly inform NICE guidance for pulmonary fibrosis. We will be working closely with patients as co-researchers, and also producing visual arts to disseminate our results, which offers a great opportunity to really learn from our patients and think differently about communication in medicine."
Funding has been agreed and the OxyPuf trial team will start to recruit patients next year.
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