Oxygen Nanobubble Drink Impact on Exercise in Pulmonary Fibrosis
Research type
Research Study
Full title
In vivo double-blind, randomized, placebo controlled, crossover investigation of the effect of oral administration of oxygen nanobubbles on the distance covered in a 6 Minute Walk Test in patients with pulmonary fibrosis
IRAS ID
308993
Contact name
Najib Rahman
Contact email
Sponsor organisation
University of Oxford / Research Governance, Ethics and Assurance
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
Approximately 1 in 5 (or 12.7 million adults) in the UK have longstanding respiratory illnesses, and 6.5 million patients report taking prescription medication to ease the burden. Many patients suffer from lung tissue damage, which impairs adequate blood oxygenation and reduces blood saturations. The current method of treatment is palliative – with the patient breathing supplemental oxygen through a oxygen cylinder and tube. This severely compromises patients’ quality of life, as they are tethered to a heavy, unwieldy oxygen cylinder, limiting their ability and willingness to leave home.
Several recent studies in both animals and humans have indicated that orally administered oxygenated nanobubbles is a safe intervention that can improve tissue oxygenation. This pilot study is a randomized, double-blinded, cross-over, placebo-controlled study will evaluate the effect of an oxygen nanobubbles drink on the exercise performance of patients with chronic lung disease, specifically Pulmonary Fibrosis (PF). Patients will conduct the 6 Minute Walk Test (6MWT) twice, once with a placebo drink and once with the oxygen nanobubbles drink, based on a randomization protocol, and this study will evaluate the distance walked, heart rate, saturations, breathlessness, and time to recovery in both cases. Patient questionnaires will be given to help understand the impact of PF on patient life. We hypothesize that drinking the oxygen nanobubbles drink will improve the delivery of oxygen to vital organs, improving the distance a patient can cover in the 6 Minute Walk Test by 30m, which is the minimum clinically important difference.
The work is part of a project funded by a philanthropic donation to develop more effective ways of providing oxygen to the body. The information gathered from this study will be critical to understand the magnitude of the effect in patients, as well as provide data to support a larger scale clinical trial.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
22/SC/0360
Date of REC Opinion
1 Nov 2022
REC opinion
Further Information Favourable Opinion