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Proven Relief in Clinical Trials

   Topics:     Consistent Efficacy Across 8 Clinical Trials
Proven Relief in Perennial Allergic Rhinitis1
Powerful Relief in Seasonal Allergic Rhinitis2
Powerful Inhibition of Pruritus and Wheal in Chronic Idiopathic Urticaria3,4

Consistent Efficacy Across 8 Clinical Trials

  • Six clinical trials in allergic rhinitis (seasonal and perennial)
    • Efficacy was demonstrated in 2,412 adult and adolescent patients (≥12 years of age) in trials 2 weeks to 6 months in duration
  • Two clinical trials in chronic idiopathic urticaria
    • Efficacy was demonstrated in 423 adult patients (≥18 years of age) in two 4-week trials

Proven Relief in Perennial Allergic Rhinitis1

  • XYZAL® was statistically superior to placebo over the first week and over 4 weeks of treatment
  • XYZAL demonstrated a significant relative improvement over placebo over week 1 in Total 4 Symptom Score (T4SS)—the sum of nasal pruritus, ocular pruritus, rhinorrhea, and sneezing
Improvement in Combined Symptoms

Six-week, placebo-controlled, randomized, double-blind, multicenter study in 294 patients 12 years of age or older with perennial allergic rhinitis who were previously sensitized to house dust mites. The primary objective was to show whether XYZAL 5 mg once-daily at bedtime would provide a statistically superior improvement vs placebo in 24-hour reflective T4SS over treatment weeks 1 and 4, and a ≥50% relative improvement from baseline vs placebo over treatment week 1. Secondary efficacy variables measured were mean T4SS over the total 6-week treatment period and mean individual symptom scores over treatment weeks 1, 4, and 6.

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Powerful Relief in Seasonal Allergic Rhinitis2

XYZAL demonstrated significant improvement in a 4-week, open-label study

  • After taking XYZAL, patients experienced a 68% symptom reduction from baseline at 4 weeks in Total 4 Symptom Score (T4SS)—the sum of nasal pruritus, ocular pruritus, rhinorrhea, and sneezing
Reduction in Overall T4SS

†Four-week, open-label, uncontrolled, multicenter study conducted in 1,290 patients with seasonal allergic rhinitis who had a T4SS of ≥6 upon enrollment. Enrolled patients were either without treatment or on another antihistamine experiencing inefficacy or excessive adverse events. The primary endpoints included efficacy as measured by T4SS. Patients were not monitored or observed on treatments prior to taking XYZAL. No information is available regarding efficacy, safety, duration, or compliance with previous treatments. The secondary endpoint was treatment-related adverse events.

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Powerful Inhibition of Pruritus and Wheal in Chronic Idiopathic Urticaria3,4

  • Over the first week, XYZAL demonstrated a significant improvement in pruritus severity
    • Significant improvement was maintained over the entire 4-week study period
Significant improvement in Pruritus and Wheals over the first week

Four-week, placebo-controlled, randomized, double-blind, parallel-group, multicenter study conducted in 166 adult patients with chronic idiopathic urticaria. The primary objective was to evaluate the effect of XYZAL 5 mg on pruritus severity over 1 and 4 weeks of treatment. Secondary objectives included pruritus duration and number and size of wheals.

  • After 4 weeks of treatment with XYZAL, 85% of patients had no or mild pruritus according to the investigators' assessment3

1. Potter PC. Levocetrizine is effective for symptom relief including nasal congestion in adolescent and adult (PAR) sensitized to house dust mites. Allergy. 2003;58:893-899.
2. Jorissen M, Bertrand B, Stiels B, Vandenbulcke K. Levocetirizine as treatment for symptoms of seasonal allergic rhinitis. B-ENT. 2006;2:55-62.
3. Kapp A, Pichler WJ. Levocetirizine is an effective treatment in patients suffering from chronic idiopathic urticaria: a randomized, double-blind, placebo-controlled, parallel, multicenter study. Int J Dermatol. 2006;45:469-474
4. Data on file, UCB, Inc.

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XYZAL has 6 years of
post-marketing experi-
ence and more than
1.3 billion patient-days
worldwide.4
4Data on file, UCB, Inc.
 

Indications and Important Safety Information

XYZAL is indicated for the relief of symptoms associated with allergic rhinitis (seasonal and perennial) and the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older.

The use of XYZAL is contraindicated in: patients with a known hypersensitivity to levocetirizine or any of the ingredients of XYZAL or to cetirizine (observed reactions range from urticaria to anaphylaxis); patients with end-stage renal impairment at less than 10 mL/min creatinine clearance or patients undergoing hemodialysis; and pediatric patients aged 6 to 11 years with impaired renal function.

Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness and motor coordination, such as operating machinery or driving a motor vehicle, after ingestion of XYZAL. Concurrent use of XYZAL with alcohol or other central nervous system (CNS) depressants should be avoided because additional reductions in alertness and additional impairment of CNS performance may occur.

In clinical trials, the most common adverse reactions in ≥2% of adult and adolescent patients (12 years of age and older) taking XYZAL 2.5 mg, XYZAL 5 mg, or placebo were somnolence (5%, 6%, 2%), nasopharyngitis (6%, 4%, 3%), fatigue (1%, 4%, 2%), dry mouth (3%, 2%, 1%), and pharyngitis (2%, 1%, 1%), respectively.

In clinical trials, the most common adverse reactions in ≥2% of pediatric patients (6-12 years of age) taking XYZAL 5 mg included pyrexia (4% vs 2% placebo), cough (3% vs <1% placebo), somnolence (3% vs <1% placebo), and epistaxis (2% vs <1% placebo).

XYZAL® is a trademark of UCB Group of companies.
© 2008 UCB, Inc. and sanofi-aventis U.S. LLC. All rights reserved. X1104-1008

Last Updated: November 2008
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