Chronic UrticariaPhase 4LevoHydroxyNCT01250652
Levocetirizine Plus Bed-Time Hydroxyzine in the Management of Corticodependent Chronic Urticaria Versus Levocetirizine Alone in High Doses
A Phase 4 study testing Levocetirizine and Levocetirizine plus Hydroxyzine in people with Chronic Urticaria, run by Association Asthma, Bulgaria at 1 site in Bulgaria.
Trial 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 /… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Urticaria
- What is being tested?
- Levocetirizine and Levocetirizine plus Hydroxyzine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBulgaria
- Study dates
- Mar 2011to Mar 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 24 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.
Who cannot join
- Patients with physically induced urticarias;
- pregnancy and lactation;
- any chronic disease requiring daily other drug treatment including, antihypertensives, antipsychotics and antidepressants;
- other skin disease
Trial locations and contacts
1 site in 1 country.
Bulgaria1 site
Medical University Sofia, Department of Allergology
Sofia, 1431
About this study
Official title: Efficacy and Safety of 20 mg Levocetirizine 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
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.
Read the detailed description
Study design:
The study will involve two distinct parts (flow chart):
- 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.
- Subsequent ambulatory treatment of the same patients with 20 mg levocetirizine alone and 15 mg levocetirizine + 50 hydroxyzine at night
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 two treatment arms: levocetirizine 20 mg per day and levocetirizine 15 mg + hydroxyzine 50 mg as evening dose 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. 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.
- Conditions
- Chronic Urticaria
- Being tested
- Levocetirizine, Levocetirizine plus Hydroxyzine
- Keywords
- Chronic urticaria, Urticaria, Antihistamine
- Medical subject headings
- Chronic Urticaria, Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevocetirizineDrug
Also called Xyzal
20 mg levocetirizine for 5 days
Levocetirizine plus HydroxyzineDrug
Also called Xyzal plus Atarax
24 patient will receive 15 mg Levocetirizine plus 50 mg Hydroxyzine at bad time for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Levocetirizine | Active comparator | 24 patients will received 20 mg Levocetirizine daily Receives: Drug: Levocetirizine |
| Levocetirizine plus Hydroxyzine | Experimental | 24 patient will receive 15 mg Levocetirizine plus 50 mg Hydroxyzine at bad time for 5 days Receives: Drug: Levocetirizine plus Hydroxyzine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (5)
Effect of the two regimens on urticaria symptoms
To compare the effect of the two regimens on urticaria symptoms (number of wheals, pruritus severity
Measured: 1 year
Effect on night time sleep
To compare the effect of the two regimens on the quality of night time sleep
Measured: 1 year
Effect on day time somnolence
To compare the effect of the two regimens on the day time somnolence.
Measured: 1 year
The effect on blood eosinophil numbers, Na+, K+, ALAT, ASAT, ECG
To document the effect of treatment with higher doses of levocetirizine or hydroxyzine on blood eosinophil numbers, Na+(sodium ion), K+(potassium ion), ALAT (Alanine transaminase), AST (Aspartate transaminase), ECG (Electrocardiogram)
Measured: 1 year
To assess adverse events
To investigate safety by assessing the nature, incidence and severity of adverse events within the treatment groups
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2010 (estimated)
- Study startMar 2011
- Primary completionFeb 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic UrticariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association Asthma, Bulgaria
- Sponsor type
- University, hospital or other
- Collaborators
- UCB Pharma
- Responsible party
- Principal investigator, Prof. Todor Popov, Association Asthma, Bulgaria
- Investigators
- Todor A Popov, MD, PhD, Principal investigator, Professor of Allergology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01250652
- Sponsor's protocol ID
- 67LH13102010
- Acronym
- LevoHydroxy
- Status last verified
- Jul 2013
- First submitted
- 30 Nov 2010
- Last updated
- 17 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 15356542Kaplan 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.
PubMed 19081615Staevska 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.
PubMed 20226302
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of 20 mg Levocetirizine 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
- ClinicalTrials.gov ID
- NCT01250652
- Acronym / sponsor ID
- LevoHydroxy / 67LH13102010
- Conditions
- Chronic Urticaria
- Keywords
- Chronic urticaria, Urticaria, Antihistamine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Association Asthma, BulgariaUniversity, hospital or other
- Collaborators
- UCB Pharma
- Study start
- Mar 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 1 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study design:
The study will involve two distinct parts (flow chart):
- 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.
- Subsequent ambulatory treatment of the same patients with 20 mg levocetirizine alone and 15 mg levocetirizine + 50 hydroxyzine at night
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 two treatment arms: levocetirizine 20 mg per day and levocetirizine 15 mg + hydroxyzine 50 mg as evening dose 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. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levocetirizine | Active comparator | Drug: Levocetirizine24 patients will received 20 mg Levocetirizine daily |
| Levocetirizine plus Hydroxyzine | Experimental | Drug: Levocetirizine plus Hydroxyzine24 patient will receive 15 mg Levocetirizine plus 50 mg Hydroxyzine at bad time for 5 days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 24 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.
Key exclusion criteria (4 listed)
- Patients with physically induced urticarias;
- pregnancy and lactation;
- any chronic disease requiring daily other drug treatment including, antihypertensives, antipsychotics and antidepressants;
- other skin disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LevocetirizineAlso: Xyzal20 mg levocetirizine for 5 days | Drug | Levocetirizine |
| Levocetirizine plus HydroxyzineAlso: Xyzal plus Atarax24 patient will receive 15 mg Levocetirizine plus 50 mg Hydroxyzine at bad time for 5 days | Drug | Levocetirizine plus Hydroxyzine |
Primary outcome
Urticaria specific quality of life
Time frame: 1 year
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.
5 secondary outcomes
Effect of the two regimens on urticaria symptoms
Time frame: 1 year
Effect on night time sleep
Time frame: 1 year
Effect on day time somnolence
Time frame: 1 year
The effect on blood eosinophil numbers, Na+, K+, ALAT, ASAT, ECG
Time frame: 1 year
To assess adverse events
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2013.
- Background: PubMed 15356542Kaplan 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.
- Background: PubMed 19081615Kaplan 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.
- Background: PubMed 20226302Staevska 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Todor A Popov, MD, PhD principal investigator
Professor of Allergology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levocetirizine and Levocetirizine plus Hydroxyzine in people with Chronic Urticaria, run by Association Asthma, Bulgaria at 1 site in Bulgaria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bulgaria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urticaria specific quality of life (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01250652, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2013.