Levocetirizine Plus Bed-Time Hydroxyzine in the Management of Corticodependent Chronic Urticaria Versus Levocetirizine Alone in High Doses

NCT01250652 | Completed Phase 4 DMC

• 1 other identifier: 67LH13102010
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Allen Kaplan is a prominent American allergist with the reputation of leader in the field of chronic urticaria. He advocates treatment with first generation hydroxyzine, which he considers at least as effective as modern second generation H1-blockers in suppressing the symptoms of difficult-to-treat / systemic-steroid-dependant cases of chronic urticaria. He further speculates that hydroxyzine may have the advantage to better suppress itch and improve nighttime sleep. This has prompted many practitioners around the world to believe that adding hydroxyzine to the treatment regimen at bed time at night may be beneficial to patients. At the same time European guidelines indicate modern second generation H1-blockers in higher than conventional doses as drugs of choice for such cases. However, there is no evidence from clinical trials addressing this controversy. The investigators' previous studies suggest that levocetirizine at quadruple doses may be beneficial in difficult to treat urticaria by reducing lesions and itch, improving quality of life and night time sleep, while not causing day time somnolence. First generation H1-receptor antagonists and hydroxyzine among them are known to penetrate the blood / brain barrier and to cause sedation. The question stays whether this sedation is beneficial to the subjects with chronic urticaria at night, whether it has any hang-over unwanted effects the following day and whether this has any influence on the overall urticaria-specific quality of life.

Conditions

Chronic Urticaria

Keywords

Chronic urticaria; Urticaria; Antihistamine

Outcome Measures

Primary Outcomes (1)

• Urticaria specific quality of life

  The primary objective of the study is to compare the effect on urticaria specific quality of life of two regimens: levocetirizine 20 mg per day (4x1 tablets) vs. levocetirizine 15 mg (3x1 tablets) + hydroxyzine 50 mg (2 tablets) before night time sleep.

  1 year

Secondary Outcomes (5)

• Effect of the two regimens on urticaria symptoms

  1 year

• Effect on night time sleep

  1 year

• Effect on day time somnolence

  1 year

• The effect on blood eosinophil numbers, Na+, K+, ALAT, ASAT, ECG

  1 year

• To assess adverse events

  1 year

Study Arms (2)

Levocetirizine

ACTIVE COMPARATOR

24 patients will received 20 mg Levocetirizine daily

Drug: Levocetirizine

Levocetirizine plus Hydroxyzine

EXPERIMENTAL

24 patient will receive 15 mg Levocetirizine plus 50 mg Hydroxyzine at bad time for 5 days

Drug: Levocetirizine plus Hydroxyzine

Interventions

Levocetirizine DRUG

20 mg levocetirizine for 5 days

Also known as: Xyzal

Levocetirizine

Levocetirizine plus Hydroxyzine DRUG

24 patient will receive 15 mg Levocetirizine plus 50 mg Hydroxyzine at bad time for 5 days

Also known as: Xyzal plus Atarax

Levocetirizine plus Hydroxyzine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• randomized patients of either sex,
• ≥18 years of age.
• Included patients should have at least a 6-week documented history of urticaria with intake of 15-30 mg Prednisolon.

You may not qualify if:

• Patients with physically induced urticarias;
• pregnancy and lactation;
• any chronic disease requiring daily other drug treatment including, antihypertensives, antipsychotics and antidepressants;
• other skin disease

Sponsors & Collaborators

• Association Asthma, Bulgaria: lead
• UCB Pharma: collaborator

Study Sites (1)

Medical University Sofia, Department of Allergology

Sofia, 1431, Bulgaria

Location

Related Publications (3)

• Kaplan AP. Chronic urticaria: pathogenesis and treatment. J Allergy Clin Immunol. 2004 Sep;114(3):465-74; quiz 475. doi: 10.1016/j.jaci.2004.02.049.

  PMID: 15356542 BACKGROUND

• Kaplan AP. What the first 10,000 patients with chronic urticaria have taught me: a personal journey. J Allergy Clin Immunol. 2009 Mar;123(3):713-7. doi: 10.1016/j.jaci.2008.10.050. Epub 2008 Dec 10. No abstract available.

  PMID: 19081615 BACKGROUND

• Staevska M, Popov TA, Kralimarkova T, Lazarova C, Kraeva S, Popova D, Church DS, Dimitrov V, Church MK. The effectiveness of levocetirizine and desloratadine in up to 4 times conventional doses in difficult-to-treat urticaria. J Allergy Clin Immunol. 2010 Mar;125(3):676-82. doi: 10.1016/j.jaci.2009.11.047.

  PMID: 20226302 BACKGROUND

MeSH Terms

Conditions

Chronic Urticaria; Urticaria

Interventions

levocetirizine; Hydroxyzine

Condition Hierarchy (Ancestors)

Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Todor A Popov, MD, PhD

  Professor of Allergology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Todor Popov

Study Record Dates

• First Submitted: November 30, 2010
• First Posted: December 1, 2010
• Study Start: March 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: March 1, 2013
• Last Updated: July 17, 2013

Record last verified: 2013-07

Locations

BU (1)