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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-005608-15-DE

Enrollment

Registered

2006-11-20

Start date

2007-02-12

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perennial allergic rhinitis MedDRA version: 8.1 Level: LLT Classification code 10034382 Term: Perennial allergic rhinitis

Interventions

Trade Name: Xusal(R) Filmtabletten Pharmaceutical Form: Tablet INN or Proposed INN: LEVOCETIRIZINE CAS Number: 130018778 Concentration unit: kg kilogram(s) Concentration type: equal Concentration numb

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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 To investigate the effect of levocetirizine on symptoms of perennial allergic rhinitis different from nasal obstruction.	—

Measure

Time frame

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 To investigate the effect of levocetirizine on symptoms of perennial allergic rhinitis different from nasal obstruction.

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Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026