MedTrace Logo

3-D Visualization of the Anti-Obstructive Effect of Levocetirizine

NCT01000792 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2011-06-22

No results posted yet for this study

Summary

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.

Conditions

  • Allergic Rhinitis

Interventions

DRUG

Levocetirizine

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

Levocetirizine

Sponsors & Collaborators

  • Clinical Research International Limited

    lead INDUSTRY

Principal Investigators

  • Ralph Mösges, M.D. · CRI-Ltd

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2010-01-31
Completion
2010-07-31

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01000792 on ClinicalTrials.gov