Do Nanobubbles Improve Joint Hypoxia?

Rheumatoid Arthritis Clinical Trial

Official title:

An Investigation of Whether Orally Delivered Nanobubbles Have a Physiological Effect on Joint Hypoxia?

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04844008
• Other study ID #: PID 15065
• Status: Withdrawn
• Phase: N/A
• Start date: October 5, 2021
• Est. completion date: May 17, 2022

Study information

• Verified date: March 2021
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 17, 2022
• Est. primary completion date: May 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• • 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.

Exclusion Criteria:

• • 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.
• 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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Hypoxia
• Psoriatic Arthritis
• Rheumatoid Arthritis

Intervention

Dietary Supplement:
• Nanobubble drink
Commercially available sports drink

Locations

Country	Name	City	State
United Kingdom	Oxford University Hospitals NHS Trust	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline in the absolute and relative cell count in synovial fluid and synovial biopsy		day 28
Other	Change from baseline of synovial fibroblast protein expression		day 28
Primary	Change in Synovial fluid pO2		Change in synovial fluid pO2 between day 1 and day 28
Secondary	Change in hypoxia-inducible factor 1a (HIF-1a) protein levels in synovial tissues		Change in hypoxia-inducible factor 1a (HIF-1a) protein between day 1 and day 28
Secondary	Treatment Satisfaction Questionnaire for Medication (C)	Validated PRO assessing: side effects, effectiveness, convenience and global satisfaction	Day28