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NCT Number: NCT05711290

Oxygen Nanobubble Drink Impact on Exercise in Pulmonary Fibrosis

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.

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Key information

Conditions

Pulmonary Fibrosis Fibrosis Lung Diseases Lung Diseases, Interstitial Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oxford University Hospitals NHS Foundation Trust

Oxford, Oxfordshire, OX3 7LE, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient is Male or Female, aged 18 years or above
  • Participant is willing and able to give informed consent for participation in the study.
  • Patients diagnosed with Pulmonary Fibrosis as per ATS/ERS guidelines, and in whom the lung fibrosis is considered the dominant cause of symptoms (i.e. no severe other disease such as COPD or heart failure)
  • The patient must be able to walk independently without a walking stick
  • The patient can, in the view of their respiratory clinician, adequately participate in a 6MW test

Exclusion criteria

  • Pregnant or breast feeding
  • History of current neurological condition (e.g., epilepsy)
  • Patient has consumed liquorice in the last 24 hours.
  • Patients with TLCO <30%
  • Patients with known unstable ischaemic heart disease or pulmonary hypertension
  • Patients with a history of smoking in the previous 30 days
  • Patients that are allergic or intolerant towards: Liquorice, Lecithin derived from soya or sunflower, Citric acid, Glycerol
  • Patients with known severe Renal Dysfunction
  • Patients with known severe Liver Dysfunction

Treatment and study plan

Oxygen Nanobubble

Dietary Supplement

This intervention consists of oxygenated nanobubbles made from lecithin with natural flavourings (liquorice, glycerol and citric acid)

Placebo

Other

The placebo does not contain nanobubbles, and is made from natural flavourings (liquorice, glycerol and citric acid).

Primary outcomes

  1. 6 Minute Walk Distance

    Time frame: 1 day

    Distance covered in 6 Minute Walk Test (6MWT) with oxygen nanobubbles drink compared with placebo drink

Secondary outcomes

  1. Breathlessness

    Time frame: 1 day

    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.

  2. Heart Rate

    Time frame: 1 day

    Heart Rate changes in 6MWT with oxygen nanobubbles drink compared with placebo drink

  3. Oxygen Saturation

    Time frame: 1 day

    SpO2 changes in 6MWT with oxygen nanobubbles drink compared with placebo drink

  4. Recovery Time

    Time frame: 1 day

    Time for SpO2 and HR to reset to resting levels after 6MWT with oxygen nanobubbles drink compared with placebo drink

  5. Patient Perception of Exercise Ability

    Time frame: 1 day

    Patient self-reporting via patient questionnaire the additional distance they believe they can walk after 6MWT with oxygen nanobubbles drink compared with placebo drink

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Collaborators

  • Oxford University Hospitals NHS Trust

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 2, 2023
Registry last updated
Oct 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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