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E Nose.

The use of the electronic nose (e nose) in the diagnosis of patients with rheumatoid arthritis.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON28353
Enrollment
30
Registered
2010-08-02
Start date
2010-07-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

RA, reuma, rheumatoid arthritis

Interventions

Methods: Electronic nose: the ‘Willem Frederik’ (Smith Detections, Pasadena, Ca, USA). When exposed to a gas mixture, the sensors will swell and thus change the electrical conductance, resulting in a

Sponsors

Academisch Medisch Centrum div Immunology and Rheumatology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Rheumatoid arthritis patients: A minimum of 15 patients 18-75 years with: 1. RA according to the ACR criteria; 2. Rheumatoid factor IgM and/or anti-CCP positive; 3. DAS28 ≥ 3.2; 4. Stable methotrexate use. Controls: A minimum of 15 asymptomatic age- and gender matched controls: 1. Non-smoking ( 12 months); 2. A negative test for Rheumatoid factor IgM and anti-CCP.

Exclusion criteria

Exclusion criteria: 1. Severe cardiovascular disease, history or present; 2. Myocardial infarction; 3. Coronary bypass surgery; 4. CVA; 5. Pulmonary embolism and deep venous thrombosis; 6. Heart failure; 7. A history of diabetes mellitus; 8. Systemic inflammatory disease other than RA; 9. A history of/or active pulmonary disease, including extra articular manifestation of RA, asthma, COPD, TBC, infection; 10. Cancer diagnosed and treated within 5 years, or known incomplete remission if earlier; 11. Presence or recent history (4 weeks) of paradontitis; 12. History of upper or lower respiratory infection in the past 4 weeks; 13. The use of inhalation medication; 14. Antihistamines, theofylline, and antibiotic use in the past 2 days; 15. The use of corticosteroids, either orally or systemic; 16. The use of intramuscular corticosteroids less than 4 weeks before inclusion; 17. The use of DMARD’s other then methotrexate; 18. Change in methotrexate dosage 28 days or less before inclusion; 19. The use of biologicals, such as anti-TNF agents, B cell depleting agents, IL-6 receptor antagonists, CTLA4Ig; 20. Eating (including chewing gum), drinking, smoking, brushing teeth < 3 hours before measurements; 21. Lack of comprehension of the study and measurements; 22. Pregnancy; 23. A history of hyper- or hypothyroid function or use of Levothyroxine; 24. A history of renal insufficiency.

Design outcomes

Primary

MeasureTime frame
The primary outcome parameter is the smell-print provided by the electronic nose, together with the results of the on-board and offline statistical analysis.

Contacts

Public ContactP.P. Tak

Academic Medical Center (AMC), Department of Clinical Immunology and Rheumatology, P.O. Box 22660

p.p.tak@amc.nl+31 (0)20 5662171

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)