NCT02372604

Efficacy of Levocetirizine Fourfold Dosage in Chronic Spontaneous Urticaria

Efficacy of Levocetirizine Fourfold Dosage in Chronic Spontaneous Urticaria Resistant to the Licensed Dosage

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Chronic Spontaneous Urticaria (CSU), defined by the persistence of daily or almost daily urticaria over 6 weeks, affects 0.5% to 1% of the general population. In more than half of the cases, it lasts more than 2 years. It can dramatically alter the quality of life, in particular sleep, and generates numerous consultations and hospitalizations, with an average annual cost per patient close to 2000 euros in Europe. The treatment is based on the validated 2nd generation anti-H1 antihistamines dosage of one tablet per day whose effectiveness is satisfactory, however about half the time. In cases of severe CSU refractory to treatment with anti-H1 licensed dosage, few therapeutic alternatives exist, still off-label: the monketulast, an anti-leukotriene, ciclosporine or methotrexate, as immunosuppressants. Various studies have shown the important benefit of an expensive anti-IgE biological: the omaluzimab. Several open studies have also suggested superior efficacy and good tolerability of anti-H1 in higher dosage (double, triple or quadruple) including levocetirizine. The off-label use of these high dosages of anti-H1 is growing very rapidly in France, tending to replace the use of anti-H1 first generation or substitution to another 2nd generation anti-H1 recommended by the French Society of Dermatology. This study, under the aegis of the Urticaria Group of the French Society of Dermatology, intends to compare the efficacy of levocetirizine 4 tablets/day versus 1 tablet/day in the treatment of CSU resistant to anti-H1 licensed dosage.

Conditions

• Chronic Spontaneous Urticaria

Interventions

Type	Name	Description
DRUG	Levocetirizine (as levocetirizine dihydrochloride), 5mg ( then 20 mg) per day . Oral administration.	Week 1 to week 5, every day : - the morning : 5 mg of levocetirizine (capsule) * the evening : placebo capsule Week 6 to week 10, every day : - the morning : 10 mg of levocetirizine (capsule) * the evening : 10 mg of levocetirizine (capsule))
DRUG	Levocetirizine, (as levocetirizine dihydrochloride) 20 mg ( then 5 mg) per day. Oral administration.	Week 1 to week 5, every day : - the morning : 10 mg of levocetirizine (tablet) * the evening : 10 mg of levocetirizine(tablet) Week 6 to week 10, every day : - the morning : 5 mg of levocetirizine (tablet) * the evening : placebo tablet

Timeline

• Start date: 2015-07-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2015-02-26
• Last updated: 2018-09-18