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E Nose.


- candidate number8294
- NTR NumberNTR2449
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-aug-2010
- Secondary IDs10/126 MEC AMC
- Public TitleE Nose.
- Scientific TitleThe use of the electronic nose (e nose) in the diagnosis of patients with rheumatoid arthritis.
- ACRONYME Nose
- hypothesisWe postulate that exhaled breath sampling by an electronic nose can distinguish patients with rheumatoid arthritis with active disease defined by a disease activity score of 28 joints (DAS28) ≥ 3.2, from non-smoking asymptomatic controls.
- Healt Condition(s) or Problem(s) studiedRheumatoid arthritis
- Inclusion criteriaRheumatoid 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 (< 5 pack-years, > 12 months);
2. A negative test for Rheumatoid factor IgM and anti-CCP.
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-jul-2010
- planned closingdate1-jul-2011
- Target number of participants30
- InterventionsMethods: 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 unique smell-print. These measurements are stored in an on-board database and can be analyzed by the pattern recognition software as well as by offline statistics software.
Breathing maneuver: Patients will breathe normally through a mouthpiece, connected to a three-way non-re-breathing valve and an inspiratory VOC-filter (A2, North Safety, NL) for 5 minutes. After a single deep inspiration the patient exhales a vital capacity volume into a Tedlar bag connected to the expiratory port. Tests will be performed in duplo.
- Primary outcomeThe primary outcome parameter is the smell-print provided by the electronic nose, together with the results of the on-board and offline statistical analysis.
- Secondary outcomeN/A
- TimepointsOne moment, test will be performed in duplo.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESProf. Dr. P.P. Tak
- CONTACT for SCIENTIFIC QUERIESProf. Dr. P.P. Tak
- Sponsor/Initiator Academic Medical Center (AMC), Division of Clinical Immunology and Rheumatology
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Division of Clinical Immunology and Rheumatology
- PublicationsN/A
- Brief summaryWe postulate that exhaled breath sampling by an electronic nose can distinguish:
Patients with rheumatoid arthritis with active disease defined by a disease activity score of 28 joints (DAS28) ≥ 3.2, from non-smoking asymptomatic controls.
Country of recruitment: the Netherlands.
- Main changes (audit trail)
- RECORD2-aug-2010 - 14-aug-2010


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