Rheumatoid ArthritisNCT04844008
Do Nanobubbles Improve Joint Hypoxia?
A study testing Nanobubble drink in people with Rheumatoid Arthritis and Psoriatic Arthritis, run by University of Oxford at 1 site in United Kingdom.
Trial summary
Inflamed joints in patients with rheumatoid arthritis and psoriatic arthritis are characterized by low oxygen levels and inflammation. We propose to investigate whether tiny bubbles (nanobubbles) when given in a drink can alter oxygen level in joints. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Psoriatic Arthritis
- What is being tested?
- Nanobubble drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Oct 2021to 17 May 2022
- 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
- • Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 years or above.
- Fulfil American College of Rheumatology/European League Against Rheumatism criteria (ACR/EULAR) 2010 Rheumatoid Arthritis Classification Criteria or fulfil Classification Criteria for Psoriatic Arthritis 2006 (CASPAR).
- Selected joint for biopsy must be minimum Grade 2 synovial thickening for large joint (knee) and medium joint (wrist), or minimum Grade 3 synovial thickening for small joint (metacarpophalangeal).
- Women of child bearing potential who are willing to use effective contraception (i.e. barrier, oral contraceptive pill, implanted contraception, or previous hysterectomy, bilateral oophorectomy) for the duration of the study.
Who cannot join
- • Currently on oxygen therapy.
- Current enrolment in any other clinical study involving an investigational study treatment.
- Pregnant or lactating, or women planning to become pregnant or initiating breastfeeding.
- Intramuscular, intravenous or intra-articular administration of corticosteroid within 4 weeks prior to baseline visit.
- Oral corticosteroid > 10 mg/day prednisolone or equivalent within 4 weeks prior to baseline visit.
- Oral corticosteroid dose not stable for at least 4 weeks prior to baseline visit.
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- Oral non-steroidal anti-inflammatory drugs (including aspirin > 75 mg/ day and selective-cyclooxygenase inhibitors) dose not stable for at least 4 weeks prior to baseline visit.
- Disease modifying anti-rheumatic drugs (DMARDs) dose not stable for at least 4 weeks prior to baseline visit.
- History of septic arthritis.
- Participants on warfarin, heparin, low molecular weight heparin, direct oral anticoagulants. Oral anti-platelet agents are permitted.
- History of haemophilia.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Oxford University Hospitals NHS Trust
Oxford, OX3 7LD
About this study
Official title: An Investigation of Whether Orally Delivered Nanobubbles Have a Physiological Effect on Joint Hypoxia?
Inflamed joints in patients with rheumatoid arthritis and psoriatic arthritis are characterized by low oxygen levels and inflammation. We propose to investigate whether tiny bubbles (nanobubbles) when given in a drink can alter oxygen level in joints. These nanobubbles are so small that they can enter the bloodstream when given as a drink. This information will give new information on the role of oxygen in joint inflammation and could possibly lead to new treatment approaches in the future.
- Conditions
- Rheumatoid Arthritis, Psoriatic Arthritis
- Being tested
- Nanobubble drink
- Medical subject headings
- Arthritis, Rheumatoid, Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nanobubble drinkDietary supplement
Commercially available sports drink
| Study group | Role | What they receive |
|---|---|---|
| Nanobubble | Experimental | Sports drink nanobubble drink Receives: Dietary Supplement: Nanobubble drink |
| control | Placebo comparator | Flavoured drink- no active ingredients Receives: Dietary Supplement: Nanobubble drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Synovial fluid pO2
Measured: Change in synovial fluid pO2 between day 1 and day 28
Secondary outcomes (2)
Change in hypoxia-inducible factor 1α (HIF-1α) protein levels in synovial tissues
Measured: Change in hypoxia-inducible factor 1α (HIF-1α) protein between day 1 and day 28
Treatment Satisfaction Questionnaire for Medication (C)
Validated PRO assessing: side effects, effectiveness, convenience and global satisfaction
Measured: Day28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study start5 Oct 2021
- Primary completion17 May 2022
- Study completion17 May 2022
Why it stopped: Changes in treatment pathway made recruitment unfeasible
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04844008
- Sponsor's protocol ID
- PID 15065
- Status last verified
- Mar 2021
- First submitted
- 30 Mar 2021
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- 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 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of Whether Orally Delivered Nanobubbles Have a Physiological Effect on Joint Hypoxia?
- ClinicalTrials.gov ID
- NCT04844008
- Acronym / sponsor ID
- PID 15065
- Conditions
- Rheumatoid Arthritis, Psoriatic Arthritis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Changes in treatment pathway made recruitment unfeasible
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 5 Oct 2021 (actual)
- Primary completion
- 17 May 2022 (actual)
- Study completion
- 17 May 2022 (actual)
- First posted
- 14 Apr 2021 (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.
Inflamed joints in patients with rheumatoid arthritis and psoriatic arthritis are characterized by low oxygen levels and inflammation. We propose to investigate whether tiny bubbles (nanobubbles) when given in a drink can alter oxygen level in joints. These nanobubbles are so small that they can enter the bloodstream when given as a drink. This information will give new information on the role of oxygen in joint inflammation and could possibly lead to new treatment approaches in the future.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nanobubble | Experimental | Dietary Supplement: Nanobubble drinkSports drink nanobubble drink |
| control | Placebo comparator | Dietary Supplement: Nanobubble drinkFlavoured drink- no active ingredients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- • Participant is willing and able to give informed consent for participation in the study.
Key exclusion criteria (11 listed)
- • Currently on oxygen therapy.
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 |
|---|---|---|
| Nanobubble drinkCommercially available sports drink | Dietary supplement | Nanobubble, control |
Primary outcome
Change in Synovial fluid pO2
Time frame: Change in synovial fluid pO2 between day 1 and day 28
2 secondary outcomes
Change in hypoxia-inducible factor 1α (HIF-1α) protein levels in synovial tissues
Time frame: Change in hypoxia-inducible factor 1α (HIF-1α) protein between day 1 and day 28
Treatment Satisfaction Questionnaire for Medication (C)
Time frame: Day28
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nanobubble drink in people with Rheumatoid Arthritis and Psoriatic Arthritis, 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 11 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: withdrawn, as of the sponsor's last update on 24 May 2022. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change in Synovial fluid pO2 (time frame: Change in synovial fluid pO2 between day 1 and day 28). 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 24 May 2022.