Efficacy of Levocetirizine in the Treatment of Nasal Obstruction Due to Perennial Rhinitis - Levocetirizine with PAR

• Conditions: Perennial allergic rhinitis; MedDRA version: 8.1Level: LLTClassification code 10034382Term: Perennial allergic rhinitis

• Registration Number: EUCTR2006-005608-15-DE
• Lead Sponsor: Institut für Atemwegsforschung GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11-20
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

- At least 2 year history of perennial allergic rhinitis with pronounced symptoms.
- Sensitization to D. farinae or D. pteronyssinus proved by a prick test (wheal diameter = 3 mm) or measurement of specific IgE (at least RAST class 2) at most one year ago.
- On visit 2: Sum of the morning nasal obstruction scores documented in the screening diary is at least 40% of the maximal sum the patient could have attained.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Severe diseases and diseases, conditions or findings which might interfere with the study results, deteriorate due to study participation or require impermissible medication. In particular this includes
(a) restricted liver or kidney function,
(b) nasal polyps, severe deviations of the nasal septum, and any other considerable impairments of nasal patency,
(c) an ear, nose or throat inflammation during the last 2 weeks or any other but allergic form of rhinitis,
(d) asthma requiring any other treatment than short acting ß-agonists on demand,
(e) atopic dermatitis with considerable probability to require corticosteroid treatment.
- Intake of impermissible medication or non observance of the designated washout periods.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): Average morning nasal obstruction score calculated from diary assessments during treatment.;Main Objective: To show that levocetirizine is more effective than placebo in the treatment of nasal obstruction due to perennial allergic rhinitis;Secondary Objective: To investigate patients' appreciation of the clinical relevance of the effect of levocetirizine on their symptoms of perennial allergic rhinitis<br>To investigate the effect of levocetirizine on symptoms of perennial allergic rhinitis different from nasal obstruction.<br>