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Levocetirizine Plus Bed-Time Hydroxyzine in the Management of Corticodependent Chronic Urticaria Versus Both Drugs Alone in High Doses (LevoHydroxy)

This study is currently recruiting participants.
Verified June 2011 by Association Asthma, Bulgaria
Sponsor:
Collaborator:
UCB, Inc.
Information provided by:
Association Asthma, Bulgaria
ClinicalTrials.gov Identifier:
NCT01250652
First received: November 30, 2010
Last updated: June 21, 2011
Last verified: June 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Chronic Urticaria
 Drug: Levocetirizine
Drug: Hydroxyzine
Drug: Levocetirizine plus Hydroxyzine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of 20 mg Levocetirizine, 200 mg Hydroxyzine and 15 mg Levocetirizine + 50 mg Bed-Time Hydroxyzine in Severe Chronic Urticaria in Adults: a Pilot, Randomized, Double-blind, Cross-over and Parallel, Active-controlled, Single-centre Study

Resource links provided by NLM:

MedlinePlus related topics: Hives
U.S. FDA Resources

Further study details as provided by Association Asthma, Bulgaria:

Primary Outcome Measures:
  • Urticaria specific quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The primary objective of the study is to compare the effect on urticaria specific quality of life of three regimens: levocetirizine 20 mg per day (4x1 tablets) vs. levocetirizine 15 mg (3x1 tablets) + hydroxyzine 50 mg (2 tablets) before night time sleep and hydroxyzine 200 mg in corticosteroid treated chronic urticaria patients


Secondary Outcome Measures:
  • Effect of the three regimens on urticaria symptoms [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    To compare the effect of the three regimens on urticaria symptoms (number of wheals, pruritus severity

  • Effect on night time sleep [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    To compare the effect of the three regimens on the quality of night time sleep

  • Effect on day time somnolence [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    To compare the effect of the three regimens on the day time somnolence.

  • The effect on blood eosinophil numbers, Na+, K+, ALAT, ASAT, ECG [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    To document the effect of treatment with higher doses of levocetirizine or hydroxizine on blood eosinophil numbers, Na+, K+, ALAT, ASAT, ECG

  • To assess adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    To investigate safety by assessing the nature, incidence and severity of adverse events within the treatment groups


Estimated Enrollment: 40
Study Start Date: March 2011
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Levocetirizine
20 patients will received 20 mg Levocetirizine daily
 Drug: Levocetirizine
20 mg levocetirizine for 5 days
Other Name: Xyzal
Experimental: Hydroxyzine
20 patients will receive 200 mg Hydroxyzine for 5 + 5 days
 Drug: Hydroxyzine
20 patients will received 200 mg hydroxyzine daily for 5+5 days
Other Name: Atarax
Experimental: Levocetirizine plus Hydroxyzine
20 patient will receive 15 mg Levocetirizine plus 50 mg Hydroxyzine at bad time for 5 days
 Drug: Levocetirizine plus Hydroxyzine
20 patient will receive 15 mg Levocetirizine plus 50 mg Hydroxyzine at bad time for 5 days
Other Name: Xyzal plus Atarax

Detailed Description:

Study design:

The study will involve two distinct parts (flow chart):

  1. In-hospital assessment of effectiveness and tolerability of 10 & 20 mg levocetirizine vs. 100 & 200 mg hydroxyzine in subjects to be weaned off corticosteroid treatment.
  2. Subsequent ambulatory treatment of the same patients with 20 mg levocetirizine alone, 15 mg levocetirizine + 50 hydroxyzine or hydroxyzine 200 mg.

Protocol description Patients with chronic urticaria treated with systemic steroids are traditionally admitted to the Clinic of Allergy and Asthma in Sofia to try to wean them off this class of drugs. Hospitalized patients will be invited to take part in the study and will sign an informed consent. They will be assessed by standard questionnaire and by objective assessment of the urticarial lesions, QoLQ will be filled in, discomfort due to urticaria, day time somnolence and night time sleep quality will be assessed on a visual analogue scale. Systemic steroids will be withheld and patients would be given 10 mg levocetirizine on Days 1 & 2; after a new assessment of quality of night time sleep and day time somnolence, 100 mg hydroxyzine will be given on Days 3 & 4. The cycle will be repeated on Days 5 & 6 and Days 7 & 8 with 20 mg levocetirizine and 200 hydroxyzine respectively. At this point patients will be discharged and randomized to three treatment arms: levocetirizine 20 mg per day, levocetirizine 15 mg + hydroxyzine 50 mg as evening dose and hydroxyzine 200 mg for 5 days. Diaries will be given to patients for assessment of daily SS, day time somnolence score, quality of night time sleep, facial tissue swelling, rescue medication with oral prednisolone, adverse events, intake of any other medications. After 5 days the patients from arm 1 and 2 will be crossed over to the alternative treatment while the patient from arm 3 will continue on hydroxyzine 200 mg for other 5 days. QoLQ questionnaire will be filled out at onset, at cross over (day 5) and at the end of the 10 day treatment period. On completion of the study subjects will be asked to state there preference for one treatment or the other.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 40 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.

Exclusion Criteria:

  • Patients with physically induced urticarias;
  • pregnancy and lactation;
  • any chronic disease requiring daily other drug treatment including, antihypertensives, antipsychotics and antidepressants;
  • other skin disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01250652

Contacts
Contact: Maria T Staevska, MD +359898201927 mari66sta@gmail.com

Locations
Bulgaria
Medical University Sofia, Department of Allergology Recruiting
Sofia, Bulgaria, 1431
Contact: Vasil D Dimitrov, MD, PhD     +359888474728     vasdim48@gmail.com    
Principal Investigator: Todor A Popov, MD, PhD            
Sub-Investigator: Maria T Staevska, MD            
Sub-Investigator: Tzvetelina L Canova, MD            
Sub-Investigator: Tanja Z Kralimarkova, MD            
Sub-Investigator: Vasil D Dimitrov, MD, PhD            
Sponsors and Collaborators
Association Asthma, Bulgaria
UCB, Inc.
Investigators
Principal Investigator: Todor A Popov, MD, PhD Professor of Allergology
  More Information

Publications:
The effectiveness of levocetirizine and desloratadine in up to 4 times conventional doses in difficult-to-treat urticaria Staevska M, Popov T, Kralimarkova T, Lazarova C, Kraeva S, Popova D, Church D, Dimitrov V, Church M J Allergy Clin Immunol 2010;125:676-82

Responsible Party: Prof. Todor Popov, Association Asthma, Bulgaria
ClinicalTrials.gov Identifier: NCT01250652     History of Changes
Other Study ID Numbers: 67LH13102010
Study First Received: November 30, 2010
Last Updated: June 21, 2011
Health Authority: Bulgaria: Bulgarian Drug Agency

Keywords provided by Association Asthma, Bulgaria:
Chronic urticaria
Urticaria
Antihistamine

Additional relevant MeSH terms:
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Hydroxyzine
Levocetirizine
Cetirizine
Antipruritics
Dermatologic Agents
 Therapeutic Uses
Pharmacologic Actions
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Histamine H1 Antagonists, Non-Sedating
Anti-Allergic Agents

ClinicalTrials.gov processed this record on May 19, 2013