Chronic Idiopathic Urticaria
Conditions
Keywords
Chronic Idiopathic Urticaria, CUTE Levocetirizine Xyzal®
Brief summary
A study to compare the clinical efficacy and safety of Levocetirizine vs. Desloratadine in patients suffering from Chronic Idiopathic Urticaria (CIU) measured by the mean pruritus severity score over the first week of treatment
Interventions
DRUGLevocetirizine
5mg oral capsules, once daily, 4 week duration
DRUGDesloratadine
5mg oral capsules, once daily, 4 week duration
Sponsors
UCB Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- At visit 1: Clinical history of Chronic Idiopathic Urticaria for a period of at least 6 weeks during the last 3 months without an identifiable cause \- At visit 2 (after a baseline period of at least 3 days): patient with adequate signs of CIU, both in terms of symptoms and severity.
Exclusion criteria
\- Any condition that would interfere with the evaluation of the therapeutic response.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Pruritus Severity Score Over the First Week of Treatment | over the first week of treatment | Pruritus severity is evaluated on an ordinal 4-point scale from 0 to 3 (0=none, 1=mild, 2=moderate). Mean pruritus severity score is averaged over the first week of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Score for Pruritus Duration Over the Four Weeks of Treatment | over the four weeks of treatment | The pruritus duration score is evaluated on an ordinal 4-point scale (0=no pruritus, 1=less than 1 hour, 2=1 to 6 hours, 3=more than 6 hours). Mean score for pruritus duration is averaged over the four weeks of treatment. |
| Mean Chronic Idiopathic Urticaria (CIU) Composite Score Over the First Week of Treatment | over the first week of treatment | CIU composite score is defined as the sum of 2 scores defined on an ordinal 4-point scale (pruritus severity score: 0=none, 1=mild, 2=moderate, 3=severe/intense; score for the number of wheals/24 h: 0=none, 1=mild or \<=20 wheals, 2=moderate or 21-50 wheals/24 h, 3=severe/intense or \>50 wheals/24 h). Mean is averaged over the 1st week of treatment. |
| Mean Chronic Idiopathic Urticaria (CIU) Composite Score Over the Four Weeks of Treatment | over the four weeks of treatment | CIU composite score is defined as the sum of two scores defined on an ordinal 4-point scale (pruritus severity score: 0=none, 1=mild, 2=moderate, 3=severe/intense; score for the number of wheals/24 h: 0=none, 1=mild or \<=20 wheals, 2=moderate or 21-50 wheals/24 h, 3=severe/intense or \>50 wheals/24 h). Mean is averaged over the 4 weeks of treatment. |
| Mean Pruritus Severity Score Over the Four Weeks of Treatment | over the four weeks of treatment | Pruritus severity is evaluated on an ordinal 4-point scale from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe/intense). Mean pruritus severity score is averaged over the four weeks of treatment. |
| Mean Score for Pruritus Duration Over the First Week of Treatment | over the first week of treatment | The pruritus duration score is evaluated on an ordinal 4-point scale (0=no pruritus, 1=less than 1 hour, 2=1 to 6 hours, 3=more than 6 hours). Mean score for pruritus duration is averaged over the first week of treatment. |
Countries
Belgium, France, Germany, Italy, Malaysia, Romania, South Africa, Spain, United Kingdom
Participant flow
Pre-assignment details
976 patients have been screened for this study. Ninety patients were ineligible for randomization, 886 have been randomized and treated. Participants flow and Baseline Characteristics refer to all patients randomized and treated.
Participants by arm
| Arm | Count |
|---|---|
| Levocetirizine 5 mg Levocetirizine 5 mg once daily for four weeks | 438 |
| Desloratadine 5 mg Desloratadine 5 mg once daily for four weeks | 448 |
| Total | 886 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 3 |
| Overall Study | Lack of Efficacy | 10 | 13 |
| Overall Study | Lost to Follow-up | 3 | 3 |
| Overall Study | Various reasons listed in study report | 6 | 7 |
| Overall Study | Withdrawal by Subject | 2 | 3 |
Baseline characteristics
| Characteristic | Levocetirizine 5 mg | Desloratadine 5 mg | Total |
|---|---|---|---|
| Age Continuous | 43.4 years STANDARD_DEVIATION 15.3 | 42.9 years STANDARD_DEVIATION 14.9 | 43.1 years STANDARD_DEVIATION 15.1 |
| Region of Enrollment Belgium | 14 participants | 10 participants | 24 participants |
| Region of Enrollment France | 79 participants | 82 participants | 161 participants |
| Region of Enrollment Germany | 109 participants | 115 participants | 224 participants |
| Region of Enrollment Italy | 62 participants | 65 participants | 127 participants |
| Region of Enrollment Malaysia | 45 participants | 44 participants | 89 participants |
| Region of Enrollment Romania | 57 participants | 56 participants | 113 participants |
| Region of Enrollment South Africa | 30 participants | 30 participants | 60 participants |
| Region of Enrollment Spain | 38 participants | 37 participants | 75 participants |
| Region of Enrollment United Kingdom | 4 participants | 9 participants | 13 participants |
| Sex: Female, Male Female | 284 Participants | 306 Participants | 590 Participants |
| Sex: Female, Male Male | 154 Participants | 142 Participants | 296 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 80 / 438 | 77 / 448 |
| serious Total, serious adverse events | 0 / 438 | 2 / 448 |
Outcome results
Primary
Mean Pruritus Severity Score Over the First Week of Treatment
Pruritus severity is evaluated on an ordinal 4-point scale from 0 to 3 (0=none, 1=mild, 2=moderate). Mean pruritus severity score is averaged over the first week of treatment.
Time frame: over the first week of treatment
Population: ITT population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Levocetirizine 5 mg | Mean Pruritus Severity Score Over the First Week of Treatment | 1.02 Units on a scale | Standard Error 0.04 |
| Desloratadine 5 mg | Mean Pruritus Severity Score Over the First Week of Treatment | 1.18 Units on a scale | Standard Error 0.04 |
Comparison: The primary hypothesis to be tested in this study was that the clinical efficacy of Levocetirizine 5 mg is superior to that of Desloratidine 5 mgp-value: <0.00195% CI: [0.07, 0.26]ANCOVA
Secondary
Mean Chronic Idiopathic Urticaria (CIU) Composite Score Over the First Week of Treatment
CIU composite score is defined as the sum of 2 scores defined on an ordinal 4-point scale (pruritus severity score: 0=none, 1=mild, 2=moderate, 3=severe/intense; score for the number of wheals/24 h: 0=none, 1=mild or \<=20 wheals, 2=moderate or 21-50 wheals/24 h, 3=severe/intense or \>50 wheals/24 h). Mean is averaged over the 1st week of treatment.
Time frame: over the first week of treatment
Population: Intent to treat (ITT) population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Levocetirizine 5 mg | Mean Chronic Idiopathic Urticaria (CIU) Composite Score Over the First Week of Treatment | 1.98 Units on a scale | Standard Error 0.08 |
| Desloratadine 5 mg | Mean Chronic Idiopathic Urticaria (CIU) Composite Score Over the First Week of Treatment | 2.23 Units on a scale | Standard Error 0.08 |
p-value: 0.00595% CI: [0.08, 0.43]ANCOVA
Secondary
Mean Chronic Idiopathic Urticaria (CIU) Composite Score Over the Four Weeks of Treatment
CIU composite score is defined as the sum of two scores defined on an ordinal 4-point scale (pruritus severity score: 0=none, 1=mild, 2=moderate, 3=severe/intense; score for the number of wheals/24 h: 0=none, 1=mild or \<=20 wheals, 2=moderate or 21-50 wheals/24 h, 3=severe/intense or \>50 wheals/24 h). Mean is averaged over the 4 weeks of treatment.
Time frame: over the four weeks of treatment
Population: Intent to treat (ITT) Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Levocetirizine 5 mg | Mean Chronic Idiopathic Urticaria (CIU) Composite Score Over the Four Weeks of Treatment | 1.71 Units on a scale | Standard Error 0.07 |
| Desloratadine 5 mg | Mean Chronic Idiopathic Urticaria (CIU) Composite Score Over the Four Weeks of Treatment | 1.88 Units on a scale | Standard Error 0.07 |
p-value: 0.04195% CI: [0.01, 0.34]ANCOVA
Secondary
Mean Pruritus Severity Score Over the Four Weeks of Treatment
Pruritus severity is evaluated on an ordinal 4-point scale from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe/intense). Mean pruritus severity score is averaged over the four weeks of treatment.
Time frame: over the four weeks of treatment
Population: Intent to treat (ITT) Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Levocetirizine 5 mg | Mean Pruritus Severity Score Over the Four Weeks of Treatment | 0.86 Units on a scale | Standard Error 0.04 |
| Desloratadine 5 mg | Mean Pruritus Severity Score Over the Four Weeks of Treatment | 0.99 Units on a scale | Standard Error 0.04 |
p-value: 0.00495% CI: [0.04, 0.22]ANCOVA
Secondary
Mean Score for Pruritus Duration Over the First Week of Treatment
The pruritus duration score is evaluated on an ordinal 4-point scale (0=no pruritus, 1=less than 1 hour, 2=1 to 6 hours, 3=more than 6 hours). Mean score for pruritus duration is averaged over the first week of treatment.
Time frame: over the first week of treatment
Population: Intent to treat (ITT) Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Levocetirizine 5 mg | Mean Score for Pruritus Duration Over the First Week of Treatment | 1.08 Units on a scale | Standard Error 0.04 |
| Desloratadine 5 mg | Mean Score for Pruritus Duration Over the First Week of Treatment | 1.24 Units on a scale | Standard Error 0.04 |
p-value: 0.00295% CI: [0.06, 0.26]ANCOVA
Secondary
Mean Score for Pruritus Duration Over the Four Weeks of Treatment
The pruritus duration score is evaluated on an ordinal 4-point scale (0=no pruritus, 1=less than 1 hour, 2=1 to 6 hours, 3=more than 6 hours). Mean score for pruritus duration is averaged over the four weeks of treatment.
Time frame: over the four weeks of treatment
Population: Intent to treat (ITT) Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Levocetirizine 5 mg | Mean Score for Pruritus Duration Over the Four Weeks of Treatment | 0.93 Units on a scale | Standard Error 0.04 |
| Desloratadine 5 mg | Mean Score for Pruritus Duration Over the Four Weeks of Treatment | 1.05 Units on a scale | Standard Error 0.04 |
p-value: 0.00995% CI: [0.03, 0.22]ANCOVA