3-D Visualization of the Anti-Obstructive Effect of Levocetirizine (LevoNasalFlo)

This study has been completed.
Sponsor:
Information provided by:
Clinical Research International Limited
ClinicalTrials.gov Identifier:
NCT01000792
First received: October 22, 2009
Last updated: June 21, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Allergic Rhinitis
Drug: Levocetirizine
Phase 3

Study Type: Interventional
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)

Resource links provided by NLM:


Further study details as provided by Clinical Research International Limited:

Primary Outcome Measures:
  • Improvement of nasal flow [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: November 2009
Study Completion Date: July 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Levocetirizine
Levo 5 mg o.d.
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject must be informed and give written informed consent for study participation
  • Subject must be able to adhere to dose and visit schedules and meet study requirements
  • Subject must be aged 18 to 65 (inclusive); gender and race are irrelevant
  • Subject must have at least a two-year history of allergic rhinitis consistent with persistent allergic rhinitis (defined as symptoms of allergic rhinitis present on four days or more per week or for four or more consecutive weeks per year)
  • In the previous pollen season, subject must have been sufficiently symptomatic, with a T6SS (reflective) symptoms severity score of at least 10 (out of max. 18). (Symptoms include nasal itching, sneezing, rhinorrhea, congestion, conjunctival itching, redness and tearing graded on a scale of 0 -absent, 1 - mild, 2 - moderate, 3 - severe)
  • Subject must have a positive skin prick test at screening to one or more allergens in the local panel of seasonal allergens (e.g. grass, tree pollen), but not to perennial allergens. Subject must demonstrate an antigen-induced skin prick wheal of at least 3mm greater in diameter than the diluent control.
  • Subject must have had a positive nasal allergen challenge within the previous six months. (see [Riechelmann])
  • Nonsterile or premenopausal female subjects must use a medically accepted method of birth control, e.g. oral contraceptives

Exclusion Criteria:

  • Failure to fulfill all of the above mentioned inclusion criteria
  • Insufficient ability to understand the nature, scope and possible consequences of the study
  • Insufficient legal competence or insufficient knowledge of the German language
  • Participation in another clinical trial within the previous three months
  • Pregnancy or lactation
  • Positive skin prick test to frequently occurring perennial allergens, e.g. house dust mites, cats
  • History of anaphylaxis and/or severe local reactions to skin testing with allergens
  • Intolerable symptoms that would make participating in the study unbearable, especially the 45 min MRI-session
  • Any viral inflammation of the upper respiratory system, acute or chronic sinusitis, rhinitis medicamentosa, nasal polyps, clinically relevant anatomic deviations of the nose, active or inactive tuberculosis of the respiratory tract, or asthma other than mild intermittent asthma treated with ß2-agonists on an as-needed basis
  • Any kind of clinically significant disease, especially any signs of active persistent allergic rhinitis, which would interfere with the study evaluations.
  • Known intolerance to levocetirizine or any other components of the study drugs
  • Surgery of the nose or the nasal sinuses within the previous six months
  • Any deviation from the norm in the physical investigation of any disease which in the investigator's judgment might require impermissible medication, influence study performance and results or affect the patients safety
  • Intake of drugs which might interfere with the study results
  • History of alcohol or drug abuse
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01000792

Locations
Germany
HNO-Praxis Dr. Pasch/Prof. Schlöndorff
Aachen, NRW, Germany, 52074
Sponsors and Collaborators
Clinical Research International Limited
Investigators
Principal Investigator: Ralph Mösges, M.D. CRI-Ltd
  More Information

No publications provided

Responsible Party: Prof. Dr. med. Dipl.-Ing. Ralph Mösges, CRI - Clinical Research International Ltd.
ClinicalTrials.gov Identifier: NCT01000792     History of Changes
Other Study ID Numbers: CRI-2009-09-001-IV
Study First Received: October 22, 2009
Last Updated: June 21, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Levocetirizine
Cetirizine
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Allergic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014