drugset / Trial / NCT00252291
Ability of Aridol to Detect Bronchial Hyperresponsiveness in Suspected Asthmatics
RandomizedCrossoverSingle-blindDiagnostic
Summary
This is a Phase 3 study to determine the sensitivity and specificity of the Aridol bronchial challenge test to detect bronchial hyperresponsiveness in patients with suspected asthma. Patients with suspected asthma of either gender, aged between 6 and 50 years, with only mildly impaired lung function (FEV1 \>70%) are to be tested with three different bronchial hyperresponsiveness challenges (Aridol, exercise and methacholine), and the results compared. A clinical diagnosis will also be made at the end of the study.
Timeline
- Start
- 2005-11
- Primary completion
- —
- Completion
- 2006-09
Publications
- Background Anderson SD, Brannan J, Spring J, Spalding N, Rodwell LT, Chan K, Gonda I, Walsh A, Clark AR. A new method for bronchial-provocation testing in asthmatic subjects using a dry powder of mannitol. Am J Respir Crit Care Med. 1997 Sep;156(3 Pt 1):758-65. doi: 10.1164/ajrccm.156.3.9701113.
- Background Subbarao P, Brannan JD, Ho B, Anderson SD, Chan HK, Coates AL. Inhaled mannitol identifies methacholine-responsive children with active asthma. Pediatr Pulmonol. 2000 Apr;29(4):291-8. doi: 10.1002/(sici)1099-0496(200004)29:43.0.co;2-a.
- Background Holzer K, Anderson SD, Chan HK, Douglass J. Mannitol as a challenge test to identify exercise-induced bronchoconstriction in elite athletes. Am J Respir Crit Care Med. 2003 Feb 15;167(4):534-7. doi: 10.1164/rccm.200208-916OC. Epub 2002 Nov 27.
- Background Koskela HO, Hyvarinen L, Brannan JD, Chan HK, Anderson SD. Sensitivity and validity of three bronchial provocation tests to demonstrate the effect of inhaled corticosteroids in asthma. Chest. 2003 Oct;124(4):1341-9. doi: 10.1378/chest.124.4.1341.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mannitol | Diagnostic / imaging agent | — | — |
| Subject | Methacholine | Diagnostic / imaging agent | — | — |