An interventional study of Oxygen Nanobubble and Placebo in Pulmonary Fibrosis, sponsored by University of Oxford. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-02.
Sponsored by University of Oxford · Not applicable, Interventional, and Treatment
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, and causes breathlessness. The current method of treatment is palliative - with the patient breathing supplemental oxygen through an 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 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, such as pulmonary fibrosis. 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 double-blind randomization protocol, and this study will evaluate the distance walked, heart rate, oxygen levels, breathlessness, and time to recovery in both cases. The investigators 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.
680 studies on the registry are indexed under Pulmonary Fibrosis; 119 are open to participants now.
This study's enrollment of 28 is below the median of 50 across 419 interventional studies indexed under Pulmonary Fibrosis.
Browse Pulmonary Fibrosis studies →University of Oxford is the lead sponsor of 794 studies on the registry; 117 are open to participants now.
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In this arm, the oxygen nanobubbles will be provided as a drink first. The oxygen nanobubbles mixture will be mixed with water and oxygenated. This will be provided as a one-time 200ml drink 10 minutes before the start of the 6 minute walk test. In this arm, the placebo will be provided as the second drink. This will be provided after atleast 2 hours after the first 6 minute walk test is completed. The placebo mixture will be mixed with water and oxygenated. This will be provided as a one-time 200ml drink 10 minutes before the start of the 6 minute walk test.
Dietary Supplement: Oxygen Nanobubble · Other: Placebo
In this arm, the placebo will be provided as a drink first. The placebo mixture will be mixed with water and oxygenated. This will be provided as a one-time 200ml drink 10 minutes before the start of the 6 minute walk test. In this arm, the oxygen nanobubbles will be provided as the second drink. This will be provided after atleast 2 hours after the first 6 minute walk test is completed. The oxygen nanobubbles mixture will be mixed with water and oxygenated. This will be provided as a one-time 200ml drink 10 minutes before the start of the 6 minute walk test.
Dietary Supplement: Oxygen Nanobubble · Other: Placebo
This intervention consists of oxygenated nanobubbles made from lecithin with natural flavourings (liquorice, glycerol and citric acid)
The placebo does not contain nanobubbles, and is made from natural flavourings (liquorice, glycerol and citric acid).
6 Minute Walk Distance
Distance covered in 6 Minute Walk Test (6MWT) with oxygen nanobubbles drink compared with placebo drink
Time frame: 1 day
Breathlessness
Changes in the Modified Borg score before and after the 6MWT with oxygen nanobubbles drink compared with placebo drink The Modified Borg (mBORG) scale from 0-10, with a higher score denoting less breathlessness and a better patient outcome.
Time frame: 1 day
Heart Rate
Heart Rate changes in 6MWT with oxygen nanobubbles drink compared with placebo drink
Time frame: 1 day
Oxygen Saturation
SpO2 changes in 6MWT with oxygen nanobubbles drink compared with placebo drink
Time frame: 1 day
Recovery Time
Time for SpO2 and HR to reset to resting levels after 6MWT with oxygen nanobubbles drink compared with placebo drink
Time frame: 1 day
Patient Perception of Exercise Ability
Patient self-reporting via patient questionnaire the additional distance they believe they can walk after 6MWT with oxygen nanobubbles drink compared with placebo drink
Time frame: 1 day
Plan to share: No
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This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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University of Oxford