Oxygen Nanobubble Drink Impact on Exercise in Pulmonary Fibrosis

NCT ID: NCT05711290

Last Updated: 2023-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-21
• Study Completion Date: 2023-08-09

Brief 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, 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.

Conditions

Pulmonary Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Oxygen Nanobubble First

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.

Group Type: EXPERIMENTAL

Oxygen Nanobubble

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo

Intervention Type: OTHER

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

Placebo First

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.

Group Type: PLACEBO_COMPARATOR

Oxygen Nanobubble

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo

Intervention Type: OTHER

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

Interventions

Oxygen Nanobubble

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oxford University Hospitals NHS Trust

OTHER

Sponsor Role: collaborator

University of Oxford

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Najib Rahman

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

Locations

Oxford University Hospitals NHS Foundation Trust

Oxford, Oxfordshire, United Kingdom

Countries

United Kingdom

Other Identifiers

308993

Identifier Type: -

Identifier Source: org_study_id