Back to resultsDo Nanobubbles Improve Joint Hypoxia?
Primary Purpose
Rheumatoid Arthritis, Psoriatic Arthritis
Status
Withdrawn
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Nanobubble drink
Sponsored by
About this trial
This is an interventional basic science trial for Rheumatoid Arthritis
Eligibility Criteria
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.
Sites / Locations
- Oxford University Hospitals NHS Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Nanobubble
control
Arm Description
Sports drink nanobubble drink
Flavoured drink- no active ingredients
Outcomes
Primary Outcome Measures
Change in Synovial fluid pO2
Secondary Outcome Measures
Change in hypoxia-inducible factor 1α (HIF-1α) protein levels in synovial tissues
Treatment Satisfaction Questionnaire for Medication (C)
Validated PRO assessing: side effects, effectiveness, convenience and global satisfaction
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04844008
Brief Title
Do Nanobubbles Improve Joint Hypoxia?
Official Title
An Investigation of Whether Orally Delivered Nanobubbles Have a Physiological Effect on Joint Hypoxia?
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Changes in treatment pathway made recruitment unfeasible
Study Start Date
October 5, 2021 (Actual)
Primary Completion Date
May 17, 2022 (Actual)
Study Completion Date
May 17, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oxford
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, Psoriatic Arthritis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nanobubble
Arm Type
Experimental
Arm Description
Sports drink nanobubble drink
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
Flavoured drink- no active ingredients
Intervention Type
Dietary Supplement
Intervention Name(s)
Nanobubble drink
Intervention Description
Commercially available sports drink
Primary Outcome Measure Information:
Title
Change in Synovial fluid pO2
Time Frame
Change in synovial fluid pO2 between day 1 and day 28
Secondary Outcome Measure Information:
Title
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
Title
Treatment Satisfaction Questionnaire for Medication (C)
Description
Validated PRO assessing: side effects, effectiveness, convenience and global satisfaction
Time Frame
Day28
Other Pre-specified Outcome Measures:
Title
Change from baseline in the absolute and relative cell count in synovial fluid and synovial biopsy
Time Frame
day 28
Title
Change from baseline of synovial fibroblast protein expression
Time Frame
day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Oxford University Hospitals NHS Trust
City
Oxford
ZIP/Postal Code
OX3 7LD
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Do Nanobubbles Improve Joint Hypoxia?
We'll reach out to this number within 24 hrs