Status:
COMPLETED
Levocetirizine in the Treatment of Nasal Obstruction Due to Perennial Allergic Rhinitis
Lead Sponsor:
Institut für Atemwegsforschung GmbH
Collaborating Sponsors:
UCB Pharma
Conditions:
Perennial Allergic Rhinitis
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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...
Detailed Description
The study is performed according to a monocentre, double-blind, placebo controlled, two arm parallel group design. It is divided in 3 periods: A 7 ± 2 day screening phase when patients are not to trea...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00439712
Start Date
February 1 2007
End Date
May 1 2007
Last Update
January 15 2008
Active Locations (1)
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1
Institut für Atemwegsforschung GmbH
Düsseldorf, North Rhine-Westphalia, Germany, 404597