Levocetirizine in the Treatment of Nasal Obstruction Due to Perennial Allergic Rhinitis

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to show that in patients suffering from perennial allergic rhinitis levocetirizine 5 mg OD relieves nasal obstruction. Furthermore the study is to investigate how relevant for these patients their nasal obstruction and the effect of levocetirizine on their nasal obstruction are.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut für Atemwegsforschung GmbH
• Collaborator: UCB Pharma
• Treatments: Cetirizine; Levocetirizine

Criteria

Inclusion Criteria:

• Age of 18 to 65 years (inclusively).

• Ability to understand nature, scope and possible consequences of the study.

• Capability and willingness to comply with the requirements of the protocol.

• Written informed consent was granted after in depth written and oral information on all relevant aspects of the study.

• Adequate contraception in case of females of child bearing potential (i.e. hormonal contraception, IUD, double barrier method, monogamous sexual relation with an monogamous partner, sexual inactivity).

• 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.

Exclusion Criteria:

• Exposure to another investigational agent within the last three months.

• Pregnancy or nursing.

• 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

• restricted liver or kidney function or respectively creatinine clearance below 50 ml/min, the clearance being estimated according to the formula by Cockcroft/Gault from serum creatinine assessed on visit 1,

• nasal polyps, severe deviations of the nasal septum, and any other considerable impairments of nasal patency,

• an ear, nose or throat infection during the last 2 weeks or any other but allergic form of rhinitis,

• asthma requiring any other treatment than short acting β-agonists on demand,

• atopic dermatitis with considerable probability to require corticosteroid treatment.

• Intake of impermissible medication or non observance of the designated washout periods.

• History of malignancy within the last 5 years.

• Drug or alcohol abuse.

• Intention to donate blood during the study period.

• Intolerance to one of the components of the trial medication.