Pulmonary FibrosisNCT05711290
Oxygen Nanobubble Drink Impact on Exercise in Pulmonary Fibrosis
A study testing Oxygen Nanobubble in people with Pulmonary Fibrosis, run by University of Oxford at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Fibrosis
- What is being tested?
- Oxygen Nanobubble
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Mar 2023to 9 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Oxford University Hospitals NHS Foundation Trust
Oxford, Oxfordshire, OX3 7LE
About this study
Official 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
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
- Being tested
- Oxygen Nanobubble, Placebo
- Medical subject headings
- Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen NanobubbleDietary supplement
This intervention consists of oxygenated nanobubbles made from lecithin with natural flavourings (liquorice, glycerol and citric acid)
PlaceboOther
The placebo does not contain nanobubbles, and is made from natural flavourings (liquorice, glycerol and citric acid).
| Study group | Role | What they receive |
|---|---|---|
| Oxygen Nanobubble First | Experimental | 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. Receives: Dietary Supplement: Oxygen Nanobubble; Other: Placebo |
| Placebo First | Placebo comparator | 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. Receives: Dietary Supplement: Oxygen Nanobubble; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 Minute Walk Distance
Distance covered in 6 Minute Walk Test (6MWT) with oxygen nanobubbles drink compared with placebo drink
Measured: 1 day
Secondary outcomes (5)
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.
Measured: 1 day
Heart Rate
Heart Rate changes in 6MWT with oxygen nanobubbles drink compared with placebo drink
Measured: 1 day
Oxygen Saturation
SpO2 changes in 6MWT with oxygen nanobubbles drink compared with placebo drink
Measured: 1 day
Recovery Time
Time for SpO2 and HR to reset to resting levels after 6MWT with oxygen nanobubbles drink compared with placebo drink
Measured: 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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start21 Mar 2023
- Primary completion8 Aug 2023
- Study completion9 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Oxford University Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- Najib Rahman, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05711290
- Sponsor's protocol ID
- 308993
- Status last verified
- Nov 2022
- First submitted
- 16 Jan 2023
- Last updated
- 2 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05711290
- Acronym / sponsor ID
- 308993
- Conditions
- Pulmonary Fibrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Oxford University Hospitals NHS Trust
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- 8 Aug 2023 (actual)
- Study completion
- 9 Aug 2023 (actual)
- First posted
- 2 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxygen Nanobubble First | Experimental | Dietary Supplement: Oxygen Nanobubble, Other: PlaceboIn 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. |
| Placebo First | Placebo comparator | Dietary Supplement: Oxygen Nanobubble, Other: PlaceboIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxygen NanobubbleThis intervention consists of oxygenated nanobubbles made from lecithin with natural flavourings (liquorice, glycerol and citric acid) | Dietary supplement | Oxygen Nanobubble First, Placebo First |
| PlaceboThe placebo does not contain nanobubbles, and is made from natural flavourings (liquorice, glycerol and citric acid). | Other | Oxygen Nanobubble First, Placebo First |
Primary outcome
6 Minute Walk Distance
Time frame: 1 day
Distance covered in 6 Minute Walk Test (6MWT) with oxygen nanobubbles drink compared with placebo drink
5 secondary outcomes
Breathlessness
Time frame: 1 day
Heart Rate
Time frame: 1 day
Oxygen Saturation
Time frame: 1 day
Recovery Time
Time frame: 1 day
Patient Perception of Exercise Ability
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Najib Rahman principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxygen Nanobubble in people with Pulmonary Fibrosis, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 Minute Walk Distance (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2023.