No registrations found.
ID
Source
Brief title
Health condition
RA, reuma, rheumatoid arthritis
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
N/A
Background summary
We 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.
Study objective
We 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.
Study design
One moment, test will be performed in duplo.
Intervention
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 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.
P.O. Box 22660
P.P. Tak
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5662171
p.p.tak@amc.nl
P.O. Box 22660
P.P. Tak
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5662171
p.p.tak@amc.nl
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 (< 5 pack-years, > 12 months);
2. A negative test for Rheumatoid factor IgM and anti-CCP.
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2343 |
| NTR-old | NTR2449 |
| Other | MEC AMC : 10/126 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |