3-D Visualization of the Anti-Obstructive Effect of Levocetirizine (LevoNasalFlo)
The prevalence of allergic rhinitis is high and appears to be rising worldwide. Therefore, it is important and necessary to understand and visualize therapy effects on this disease. In this study we will demonstrate the effect of levocetirizine on nasal cavity dimensions by assessing not only standard nasal flow diagnostics such as rhinomanometry and acoustic rhinometry, but supplement exami¬nation procedures with long-term rhinometry and magnetic resonance imaging (MRI). With the aid of a virtual model and computer fluid dynamics, we are able to simulate nasal air flow and provide three-dimensional visualization of the computed flow.
In previous trials ([Bachert], [deBlic], [Day] and [Deruaz]) it has been shown that allergic symptoms, especially nasal congestion, diminish significantly under treatment with levocetirizine. We will demonstrate this anti-obstructive effect by comparing the reaction to nasal allergen challenge before and after four-week treatment with levocetirizine.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||3-D Visualization of the Anti-Obstructive Effect of Levocetirizine - A Monocentric Clinical Trail With One Patient (Phase-IV-Study)|
- Improvement of nasal flow [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||November 2009|
|Study Completion Date:||July 2010|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
Levo 5 mg o.d.
The study drug is Xyzal® 5 mg (API: levocetirizine dihydrochloride). 28 film tablets will be dispensed. Oral intake should be performed once daily (administration in the evening).Drug: Levocetirizine
Please refer to this study by its ClinicalTrials.gov identifier: NCT01000792
|HNO-Praxis Dr. Pasch/Prof. Schlöndorff|
|Aachen, NRW, Germany, 52074|
|Principal Investigator:||Ralph Mösges, M.D.||CRI-Ltd|