Allergic, Rhinitis, Seasonal
Conditions
Keywords
Levocetirizine, Xyzal, Rhinitis, Allergic, Seasonal, Ragweed
Brief summary
The purpose of the study is to assess the efficacy comparability of cetirizine and levocetirizine, by comparing the effects of single intake of the two drugs to placebo in reducing symptoms of seasonal allergic rhinitis (SAR) in ragweed sensitive adult subjects exposed to ragweed pollen in an Environmental Exposure Unit.
Interventions
DRUGPlacebo drops
* Pharmaceutical form: Drops for oral administration * Route of administration: Oral use
DRUGPlacebo tablets matching to levocetirizine
* Pharmaceutical form: Tablets for oral administration * Route of administration: Oral use
DRUGPlacebo tablets matching to cetirizine
* Pharmaceutical form: Tablets for oral administration * Route of administration: Oral use
DRUGLevocetirizine drops
* Pharmaceutical form: Drops for oral administration * Concentration: 5 mg/ml * Route of administration: Oral use
DRUGLevocetirizine tablets
* Pharmaceutical form: Tablets for oral administration * Concentration: 5 mg * Route of administration: Oral use
DRUGCetirizine drops
* Pharmaceutical form: Drops for oral administration * Concentration: 10 mg/ml * Route of administration: Oral use
DRUGCetirizine tablets
* Pharmaceutical form: Tablets for oral administration * Concentration: 10 mg * Route of administration: Oral use
Sponsors
UCB Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female subject of non-childbearing potential or of childbearing potential agreeing not to become pregnant during the study. * Have had seasonal allergic rhinitis due to Ragweed for the last 2 consecutive years * Subjects who obtain a minimum sum considering SAR related symptoms (mean value) as defined by protocol
Exclusion criteria
* Any clinically significant condition that might interfere with the treatment evaluation, both for efficacy and safety * Have used forbidden concomitant medications as defined by the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Major Symptom Complex (MSC) Score Over Period I | Baseline, Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)] | Six individual symptoms which are most dominant in the rhinitis symptom profile will be combined to form the MSC severity score: Runny nose (right and left), itchy nose (right and left), sniffles, nose blows, sneezes, watery eyes. Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The total MSC score ranges from 0 - 36. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the MSC Score Over the Total Treatment Period (Period I + Period II) | Baseline to Day 2 | Six individual symptoms which are most dominant in the rhinitis symptom profile will be combined to form the MSC severity score: Runny nose (right and left), itchy nose (right and left), sniffles, nose blows, sneezes, watery eyes. Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The total MSC score ranges from 0 - 36. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline. |
| Change From Baseline in the Total Symptom Complex (TSC) Score Over Period I | Baseline, Treatment Period I [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)] | The TSC score was calculated as the sum of the following 10 individual symptom scores: runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip. Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The TSC score ranges from 0 to 56. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline. |
| Change From Baseline in the Total Symptom Complex (TSC) Score Over Period II | Baseline, Treatment Period II [Day 2, (8:30 am to 12:00 pm)] | The TSC score was calculated as the sum of the following 10 individual symptom scores: runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip. Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The TSC score ranges from 0 to 56. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline. |
| Change From Baseline in the MSC Score Over Period II | Baseline, Treatment Period II [Day 2, (8:30 am to 12:00 pm)] | Six individual symptoms which are most dominant in the rhinitis symptom profile will be combined to form the MSC severity score: Runny nose (right and left), itchy nose (right and left), sniffles, nose blows, sneezes, watery eyes. Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The total MSC score ranges from 0 - 36. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline. |
| Change From Baseline in the Individual Symptom Scores Over Period I | Baseline, Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)] | Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Watery Eyes Score, Sneezes Score, Nose Blows Score. The subjects had to evaluate the severity of the symptoms using a scale from None to Very severe (ranging from 0 to 5). For Sneezes Score and Nose Blows Score, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline. |
| Change From Baseline in the Individual Symptom Scores Over Period II | Baseline, Treatment Period II [Day 2, (8:30 am to 12:00 pm)] | Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Watery Eyes Score, Sneezes Score, Nose Blows Score. The subjects had to evaluate the severity of the symptoms using a scale from None to Very severe (ranging from 0 to 5). For Sneezes Score and Nose Blows Score, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline. |
| Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II) | Baseline to Day 2 | Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Watery Eyes Score, Sneezes Score, Nose Blows Score. The subjects had to evaluate the severity of the symptoms using a scale from None to Very severe (ranging from 0 to 5). For Sneezes Score and Nose Blows Score, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline. |
| Change From Baseline in the Total Symptom Complex (TSC) Score Over the Total Treatment Period (Period I + Period II) | Baseline to Day 2 | The TSC score was calculated as the sum of the following 10 individual symptom scores: runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip. Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The TSC score ranges from 0 to 56. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline. |
Countries
Canada
Participant flow
Recruitment details
Participant Flow refers to the Randomized Set.
Participants by arm
| Arm | Count |
|---|---|
| Placebo (PBO) A single dose of placebo was administered orally on Day 1. | 78 |
| Levocetirizine (LCTZ) 2.5 mg A single dose of 2.5 mg of LCTZ oral drops was administered orally on Day 1. | 116 |
| Levocetirizine (LCTZ) 5 mg A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1. | 119 |
| Cetirizine (CTZ) 5 mg A single dose of 5 mg of CTZ oral drops was administered orally on Day 1. | 119 |
| Cetirizine (CTZ) 10 mg A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1. | 119 |
| Total Title | 551 |
| Total | 1,102 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 1 | 0 | 1 |
| Overall Study | Intake of prohibited medication | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Patient missed visit | 0 | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Placebo (PBO) | Levocetirizine (LCTZ) 2.5 mg | Levocetirizine (LCTZ) 5 mg | Cetirizine (CTZ) 5 mg | Cetirizine (CTZ) 10 mg | Total Title |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 2 Participants | 2 Participants | 6 Participants | 4 Participants | 15 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 3 Participants | 0 Participants | 1 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 76 Participants | 113 Participants | 114 Participants | 113 Participants | 114 Participants | 530 Participants |
| Age, Continuous | 33.71 years STANDARD_DEVIATION 12.46 | 33.45 years STANDARD_DEVIATION 11.28 | 34.36 years STANDARD_DEVIATION 12.84 | 32.91 years STANDARD_DEVIATION 11.3 | 34.33 years STANDARD_DEVIATION 11.65 | 33.76 years STANDARD_DEVIATION 11.86 |
| Sex: Female, Male Female | 42 Participants | 65 Participants | 68 Participants | 65 Participants | 72 Participants | 312 Participants |
| Sex: Female, Male Male | 36 Participants | 51 Participants | 51 Participants | 54 Participants | 47 Participants | 239 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 78 | 0 / 116 | 0 / 119 | 0 / 119 | 0 / 119 |
| other Total, other adverse events | 5 / 78 | 10 / 116 | 9 / 119 | 13 / 119 | 7 / 119 |
| serious Total, serious adverse events | 0 / 78 | 0 / 116 | 0 / 119 | 0 / 119 | 0 / 119 |
Outcome results
Primary
Change From Baseline in the Major Symptom Complex (MSC) Score Over Period I
Six individual symptoms which are most dominant in the rhinitis symptom profile will be combined to form the MSC severity score: Runny nose (right and left), itchy nose (right and left), sniffles, nose blows, sneezes, watery eyes. Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The total MSC score ranges from 0 - 36. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.
Time frame: Baseline, Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]
Population: Only patients with valid MSC scores in Period I were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo (PBO) | Change From Baseline in the Major Symptom Complex (MSC) Score Over Period I | -3.80 units on a scale | Standard Error 0.495 |
| Levocetirizine (LCTZ) 2.5 mg | Change From Baseline in the Major Symptom Complex (MSC) Score Over Period I | -7.15 units on a scale | Standard Error 0.406 |
| Levocetirizine (LCTZ) 5 mg | Change From Baseline in the Major Symptom Complex (MSC) Score Over Period I | -7.05 units on a scale | Standard Error 0.401 |
| Cetirizine (CTZ) 5 mg | Change From Baseline in the Major Symptom Complex (MSC) Score Over Period I | -7.93 units on a scale | Standard Error 0.401 |
| Cetirizine (CTZ) 10 mg | Change From Baseline in the Major Symptom Complex (MSC) Score Over Period I | -7.54 units on a scale | Standard Error 0.401 |
p-value: <0.00195% CI: [-4.61, -2.09]ANCOVA
p-value: <0.00195% CI: [-4.5, -2]ANCOVA
p-value: <0.00195% CI: [-5.38, -2.88]ANCOVA
p-value: <0.00195% CI: [-4.99, -2.49]ANCOVA
Secondary
Change From Baseline in the Individual Symptom Scores Over Period I
Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Watery Eyes Score, Sneezes Score, Nose Blows Score. The subjects had to evaluate the severity of the symptoms using a scale from None to Very severe (ranging from 0 to 5). For Sneezes Score and Nose Blows Score, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.
Time frame: Baseline, Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]
Population: Only subjects with valid individual symptom scores in Period I were included in the analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (PBO) | Change From Baseline in the Individual Symptom Scores Over Period I | Sneezes Score | -0.37 units on a scale | Standard Error 0.103 |
| Placebo (PBO) | Change From Baseline in the Individual Symptom Scores Over Period I | Sniffles Score | -0.65 units on a scale | Standard Error 0.1 |
| Placebo (PBO) | Change From Baseline in the Individual Symptom Scores Over Period I | Itchy Nose Score | -0.66 units on a scale | Standard Error 0.099 |
| Placebo (PBO) | Change From Baseline in the Individual Symptom Scores Over Period I | Nose Blow Score | -0.98 units on a scale | Standard Error 0.129 |
| Placebo (PBO) | Change From Baseline in the Individual Symptom Scores Over Period I | Runny Nose Score | -0.60 units on a scale | Standard Error 0.095 |
| Placebo (PBO) | Change From Baseline in the Individual Symptom Scores Over Period I | Watery Eyes Score | -0.56 units on a scale | Standard Error 0.09 |
| Levocetirizine (LCTZ) 2.5 mg | Change From Baseline in the Individual Symptom Scores Over Period I | Watery Eyes Score | -0.94 units on a scale | Standard Error 0.074 |
| Levocetirizine (LCTZ) 2.5 mg | Change From Baseline in the Individual Symptom Scores Over Period I | Runny Nose Score | -1.01 units on a scale | Standard Error 0.078 |
| Levocetirizine (LCTZ) 2.5 mg | Change From Baseline in the Individual Symptom Scores Over Period I | Sneezes Score | -1.15 units on a scale | Standard Error 0.084 |
| Levocetirizine (LCTZ) 2.5 mg | Change From Baseline in the Individual Symptom Scores Over Period I | Sniffles Score | -1.15 units on a scale | Standard Error 0.082 |
| Levocetirizine (LCTZ) 2.5 mg | Change From Baseline in the Individual Symptom Scores Over Period I | Itchy Nose Score | -1.03 units on a scale | Standard Error 0.082 |
| Levocetirizine (LCTZ) 2.5 mg | Change From Baseline in the Individual Symptom Scores Over Period I | Nose Blow Score | -1.87 units on a scale | Standard Error 0.106 |
| Levocetirizine (LCTZ) 5 mg | Change From Baseline in the Individual Symptom Scores Over Period I | Sniffles Score | -1.06 units on a scale | Standard Error 0.081 |
| Levocetirizine (LCTZ) 5 mg | Change From Baseline in the Individual Symptom Scores Over Period I | Sneezes Score | -1.07 units on a scale | Standard Error 0.083 |
| Levocetirizine (LCTZ) 5 mg | Change From Baseline in the Individual Symptom Scores Over Period I | Runny Nose Score | -0.95 units on a scale | Standard Error 0.077 |
| Levocetirizine (LCTZ) 5 mg | Change From Baseline in the Individual Symptom Scores Over Period I | Itchy Nose Score | -1.09 units on a scale | Standard Error 0.081 |
| Levocetirizine (LCTZ) 5 mg | Change From Baseline in the Individual Symptom Scores Over Period I | Nose Blow Score | -1.82 units on a scale | Standard Error 0.105 |
| Levocetirizine (LCTZ) 5 mg | Change From Baseline in the Individual Symptom Scores Over Period I | Watery Eyes Score | -1.08 units on a scale | Standard Error 0.073 |
| Cetirizine (CTZ) 5 mg | Change From Baseline in the Individual Symptom Scores Over Period I | Watery Eyes Score | -1.13 units on a scale | Standard Error 0.073 |
| Cetirizine (CTZ) 5 mg | Change From Baseline in the Individual Symptom Scores Over Period I | Sniffles Score | -1.24 units on a scale | Standard Error 0.081 |
| Cetirizine (CTZ) 5 mg | Change From Baseline in the Individual Symptom Scores Over Period I | Nose Blow Score | -1.92 units on a scale | Standard Error 0.105 |
| Cetirizine (CTZ) 5 mg | Change From Baseline in the Individual Symptom Scores Over Period I | Runny Nose Score | -1.17 units on a scale | Standard Error 0.077 |
| Cetirizine (CTZ) 5 mg | Change From Baseline in the Individual Symptom Scores Over Period I | Itchy Nose Score | -1.28 units on a scale | Standard Error 0.081 |
| Cetirizine (CTZ) 5 mg | Change From Baseline in the Individual Symptom Scores Over Period I | Sneezes Score | -1.22 units on a scale | Standard Error 0.083 |
| Cetirizine (CTZ) 10 mg | Change From Baseline in the Individual Symptom Scores Over Period I | Sniffles Score | -1.10 units on a scale | Standard Error 0.081 |
| Cetirizine (CTZ) 10 mg | Change From Baseline in the Individual Symptom Scores Over Period I | Sneezes Score | -1.23 units on a scale | Standard Error 0.083 |
| Cetirizine (CTZ) 10 mg | Change From Baseline in the Individual Symptom Scores Over Period I | Watery Eyes Score | -1.07 units on a scale | Standard Error 0.073 |
| Cetirizine (CTZ) 10 mg | Change From Baseline in the Individual Symptom Scores Over Period I | Runny Nose Score | -1.04 units on a scale | Standard Error 0.077 |
| Cetirizine (CTZ) 10 mg | Change From Baseline in the Individual Symptom Scores Over Period I | Itchy Nose Score | -1.10 units on a scale | Standard Error 0.081 |
| Cetirizine (CTZ) 10 mg | Change From Baseline in the Individual Symptom Scores Over Period I | Nose Blow Score | -1.96 units on a scale | Standard Error 0.105 |
Secondary
Change From Baseline in the Individual Symptom Scores Over Period II
Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Watery Eyes Score, Sneezes Score, Nose Blows Score. The subjects had to evaluate the severity of the symptoms using a scale from None to Very severe (ranging from 0 to 5). For Sneezes Score and Nose Blows Score, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.
Time frame: Baseline, Treatment Period II [Day 2, (8:30 am to 12:00 pm)]
Population: Only subjects with valid individual symptom scores in Period II were included in the analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (PBO) | Change From Baseline in the Individual Symptom Scores Over Period II | Itchy Nose Score | -0.57 units on a scale | Standard Error 0.12 |
| Placebo (PBO) | Change From Baseline in the Individual Symptom Scores Over Period II | Watery Eyes Score | -0.30 units on a scale | Standard Error 0.119 |
| Placebo (PBO) | Change From Baseline in the Individual Symptom Scores Over Period II | Sniffles Score | -0.58 units on a scale | Standard Error 0.127 |
| Placebo (PBO) | Change From Baseline in the Individual Symptom Scores Over Period II | Nose Blow Score | -1.00 units on a scale | Standard Error 0.162 |
| Placebo (PBO) | Change From Baseline in the Individual Symptom Scores Over Period II | Runny Nose Score | -0.62 units on a scale | Standard Error 0.122 |
| Placebo (PBO) | Change From Baseline in the Individual Symptom Scores Over Period II | Sneezes Score | -0.48 units on a scale | Standard Error 0.112 |
| Levocetirizine (LCTZ) 2.5 mg | Change From Baseline in the Individual Symptom Scores Over Period II | Sniffles Score | -0.91 units on a scale | Standard Error 0.103 |
| Levocetirizine (LCTZ) 2.5 mg | Change From Baseline in the Individual Symptom Scores Over Period II | Watery Eyes Score | -0.78 units on a scale | Standard Error 0.097 |
| Levocetirizine (LCTZ) 2.5 mg | Change From Baseline in the Individual Symptom Scores Over Period II | Itchy Nose Score | -1.00 units on a scale | Standard Error 0.097 |
| Levocetirizine (LCTZ) 2.5 mg | Change From Baseline in the Individual Symptom Scores Over Period II | Runny Nose Score | -0.86 units on a scale | Standard Error 0.098 |
| Levocetirizine (LCTZ) 2.5 mg | Change From Baseline in the Individual Symptom Scores Over Period II | Nose Blow Score | -1.61 units on a scale | Standard Error 0.131 |
| Levocetirizine (LCTZ) 2.5 mg | Change From Baseline in the Individual Symptom Scores Over Period II | Sneezes Score | -1.18 units on a scale | Standard Error 0.091 |
| Levocetirizine (LCTZ) 5 mg | Change From Baseline in the Individual Symptom Scores Over Period II | Itchy Nose Score | -1.11 units on a scale | Standard Error 0.097 |
| Levocetirizine (LCTZ) 5 mg | Change From Baseline in the Individual Symptom Scores Over Period II | Sniffles Score | -0.96 units on a scale | Standard Error 0.102 |
| Levocetirizine (LCTZ) 5 mg | Change From Baseline in the Individual Symptom Scores Over Period II | Runny Nose Score | -0.94 units on a scale | Standard Error 0.098 |
| Levocetirizine (LCTZ) 5 mg | Change From Baseline in the Individual Symptom Scores Over Period II | Watery Eyes Score | -0.91 units on a scale | Standard Error 0.096 |
| Levocetirizine (LCTZ) 5 mg | Change From Baseline in the Individual Symptom Scores Over Period II | Sneezes Score | -1.33 units on a scale | Standard Error 0.09 |
| Levocetirizine (LCTZ) 5 mg | Change From Baseline in the Individual Symptom Scores Over Period II | Nose Blow Score | -1.84 units on a scale | Standard Error 0.131 |
| Cetirizine (CTZ) 5 mg | Change From Baseline in the Individual Symptom Scores Over Period II | Watery Eyes Score | -0.83 units on a scale | Standard Error 0.096 |
| Cetirizine (CTZ) 5 mg | Change From Baseline in the Individual Symptom Scores Over Period II | Nose Blow Score | -1.78 units on a scale | Standard Error 0.13 |
| Cetirizine (CTZ) 5 mg | Change From Baseline in the Individual Symptom Scores Over Period II | Sniffles Score | -0.90 units on a scale | Standard Error 0.101 |
| Cetirizine (CTZ) 5 mg | Change From Baseline in the Individual Symptom Scores Over Period II | Runny Nose Score | -0.95 units on a scale | Standard Error 0.097 |
| Cetirizine (CTZ) 5 mg | Change From Baseline in the Individual Symptom Scores Over Period II | Itchy Nose Score | -1.13 units on a scale | Standard Error 0.096 |
| Cetirizine (CTZ) 5 mg | Change From Baseline in the Individual Symptom Scores Over Period II | Sneezes Score | -1.19 units on a scale | Standard Error 0.089 |
| Cetirizine (CTZ) 10 mg | Change From Baseline in the Individual Symptom Scores Over Period II | Watery Eyes Score | -0.93 units on a scale | Standard Error 0.096 |
| Cetirizine (CTZ) 10 mg | Change From Baseline in the Individual Symptom Scores Over Period II | Runny Nose Score | -1.10 units on a scale | Standard Error 0.098 |
| Cetirizine (CTZ) 10 mg | Change From Baseline in the Individual Symptom Scores Over Period II | Itchy Nose Score | -1.24 units on a scale | Standard Error 0.096 |
| Cetirizine (CTZ) 10 mg | Change From Baseline in the Individual Symptom Scores Over Period II | Sniffles Score | -1.21 units on a scale | Standard Error 0.102 |
| Cetirizine (CTZ) 10 mg | Change From Baseline in the Individual Symptom Scores Over Period II | Nose Blow Score | -2.02 units on a scale | Standard Error 0.13 |
| Cetirizine (CTZ) 10 mg | Change From Baseline in the Individual Symptom Scores Over Period II | Sneezes Score | -1.38 units on a scale | Standard Error 0.09 |
Secondary
Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II)
Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Watery Eyes Score, Sneezes Score, Nose Blows Score. The subjects had to evaluate the severity of the symptoms using a scale from None to Very severe (ranging from 0 to 5). For Sneezes Score and Nose Blows Score, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.
Time frame: Baseline to Day 2
Population: Only subjects with valid individual symptom scores in Period I and II were included in the analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (PBO) | Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II) | Itchy Nose Score | -0.61 units on a scale | Standard Error 0.097 |
| Placebo (PBO) | Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II) | Watery Eyes Score | -0.44 units on a scale | Standard Error 0.089 |
| Placebo (PBO) | Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II) | Runny Nose Score | -0.59 units on a scale | Standard Error 0.093 |
| Placebo (PBO) | Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II) | Sneezes Score | -0.41 units on a scale | Standard Error 0.09 |
| Placebo (PBO) | Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II) | Nose Blow Score | -0.98 units on a scale | Standard Error 0.124 |
| Placebo (PBO) | Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II) | Sniffles Score | -0.60 units on a scale | Standard Error 0.098 |
| Levocetirizine (LCTZ) 2.5 mg | Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II) | Sneezes Score | -1.17 units on a scale | Standard Error 0.074 |
| Levocetirizine (LCTZ) 2.5 mg | Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II) | Watery Eyes Score | -0.87 units on a scale | Standard Error 0.073 |
| Levocetirizine (LCTZ) 2.5 mg | Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II) | Itchy Nose Score | -1.02 units on a scale | Standard Error 0.08 |
| Levocetirizine (LCTZ) 2.5 mg | Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II) | Sniffles Score | -1.05 units on a scale | Standard Error 0.08 |
| Levocetirizine (LCTZ) 2.5 mg | Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II) | Runny Nose Score | -0.94 units on a scale | Standard Error 0.076 |
| Levocetirizine (LCTZ) 2.5 mg | Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II) | Nose Blow Score | -1.75 units on a scale | Standard Error 0.102 |
| Levocetirizine (LCTZ) 5 mg | Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II) | Watery Eyes Score | -1.01 units on a scale | Standard Error 0.072 |
| Levocetirizine (LCTZ) 5 mg | Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II) | Sniffles Score | -1.02 units on a scale | Standard Error 0.079 |
| Levocetirizine (LCTZ) 5 mg | Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II) | Sneezes Score | -1.19 units on a scale | Standard Error 0.073 |
| Levocetirizine (LCTZ) 5 mg | Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II) | Nose Blow Score | -1.83 units on a scale | Standard Error 0.1 |
| Levocetirizine (LCTZ) 5 mg | Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II) | Runny Nose Score | -0.95 units on a scale | Standard Error 0.075 |
| Levocetirizine (LCTZ) 5 mg | Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II) | Itchy Nose Score | -1.10 units on a scale | Standard Error 0.079 |
| Cetirizine (CTZ) 5 mg | Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II) | Itchy Nose Score | -1.21 units on a scale | Standard Error 0.079 |
| Cetirizine (CTZ) 5 mg | Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II) | Nose Blow Score | -1.86 units on a scale | Standard Error 0.101 |
| Cetirizine (CTZ) 5 mg | Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II) | Sniffles Score | -1.09 units on a scale | Standard Error 0.079 |
| Cetirizine (CTZ) 5 mg | Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II) | Runny Nose Score | -1.07 units on a scale | Standard Error 0.075 |
| Cetirizine (CTZ) 5 mg | Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II) | Watery Eyes Score | -1.00 units on a scale | Standard Error 0.073 |
| Cetirizine (CTZ) 5 mg | Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II) | Sneezes Score | -1.21 units on a scale | Standard Error 0.073 |
| Cetirizine (CTZ) 10 mg | Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II) | Watery Eyes Score | -1.01 units on a scale | Standard Error 0.072 |
| Cetirizine (CTZ) 10 mg | Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II) | Runny Nose Score | -1.06 units on a scale | Standard Error 0.075 |
| Cetirizine (CTZ) 10 mg | Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II) | Itchy Nose Score | -1.16 units on a scale | Standard Error 0.079 |
| Cetirizine (CTZ) 10 mg | Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II) | Sniffles Score | -1.15 units on a scale | Standard Error 0.079 |
| Cetirizine (CTZ) 10 mg | Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II) | Nose Blow Score | -1.99 units on a scale | Standard Error 0.1 |
| Cetirizine (CTZ) 10 mg | Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II) | Sneezes Score | -1.31 units on a scale | Standard Error 0.073 |
Secondary
Change From Baseline in the MSC Score Over Period II
Six individual symptoms which are most dominant in the rhinitis symptom profile will be combined to form the MSC severity score: Runny nose (right and left), itchy nose (right and left), sniffles, nose blows, sneezes, watery eyes. Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The total MSC score ranges from 0 - 36. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.
Time frame: Baseline, Treatment Period II [Day 2, (8:30 am to 12:00 pm)]
Population: Only patients with valid MSC scores in Period II were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo (PBO) | Change From Baseline in the MSC Score Over Period II | -3.50 units on a scale | Standard Error 0.604 |
| Levocetirizine (LCTZ) 2.5 mg | Change From Baseline in the MSC Score Over Period II | -6.35 units on a scale | Standard Error 0.489 |
| Levocetirizine (LCTZ) 5 mg | Change From Baseline in the MSC Score Over Period II | -7.07 units on a scale | Standard Error 0.487 |
| Cetirizine (CTZ) 5 mg | Change From Baseline in the MSC Score Over Period II | -6.78 units on a scale | Standard Error 0.483 |
| Cetirizine (CTZ) 10 mg | Change From Baseline in the MSC Score Over Period II | -7.92 units on a scale | Standard Error 0.485 |
Secondary
Change From Baseline in the MSC Score Over the Total Treatment Period (Period I + Period II)
Six individual symptoms which are most dominant in the rhinitis symptom profile will be combined to form the MSC severity score: Runny nose (right and left), itchy nose (right and left), sniffles, nose blows, sneezes, watery eyes. Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The total MSC score ranges from 0 - 36. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.
Time frame: Baseline to Day 2
Population: Only patients with valid MSC scores in Period I and II were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo (PBO) | Change From Baseline in the MSC Score Over the Total Treatment Period (Period I + Period II) | -3.61 units on a scale | Standard Error 0.473 |
| Levocetirizine (LCTZ) 2.5 mg | Change From Baseline in the MSC Score Over the Total Treatment Period (Period I + Period II) | -6.80 units on a scale | Standard Error 0.388 |
| Levocetirizine (LCTZ) 5 mg | Change From Baseline in the MSC Score Over the Total Treatment Period (Period I + Period II) | -7.10 units on a scale | Standard Error 0.383 |
| Cetirizine (CTZ) 5 mg | Change From Baseline in the MSC Score Over the Total Treatment Period (Period I + Period II) | -7.43 units on a scale | Standard Error 0.384 |
| Cetirizine (CTZ) 10 mg | Change From Baseline in the MSC Score Over the Total Treatment Period (Period I + Period II) | -7.72 units on a scale | Standard Error 0.383 |
Secondary
Change From Baseline in the Total Symptom Complex (TSC) Score Over Period I
The TSC score was calculated as the sum of the following 10 individual symptom scores: runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip. Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The TSC score ranges from 0 to 56. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.
Time frame: Baseline, Treatment Period I [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]
Population: Only patients with valid TSC scores in Period I were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo (PBO) | Change From Baseline in the Total Symptom Complex (TSC) Score Over Period I | -6.55 units on a scale | Standard Error 0.757 |
| Levocetirizine (LCTZ) 2.5 mg | Change From Baseline in the Total Symptom Complex (TSC) Score Over Period I | -11.33 units on a scale | Standard Error 0.62 |
| Levocetirizine (LCTZ) 5 mg | Change From Baseline in the Total Symptom Complex (TSC) Score Over Period I | -11.27 units on a scale | Standard Error 0.613 |
| Cetirizine (CTZ) 5 mg | Change From Baseline in the Total Symptom Complex (TSC) Score Over Period I | -12.71 units on a scale | Standard Error 0.613 |
| Cetirizine (CTZ) 10 mg | Change From Baseline in the Total Symptom Complex (TSC) Score Over Period I | -11.74 units on a scale | Standard Error 0.613 |
Secondary
Change From Baseline in the Total Symptom Complex (TSC) Score Over Period II
The TSC score was calculated as the sum of the following 10 individual symptom scores: runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip. Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The TSC score ranges from 0 to 56. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.
Time frame: Baseline, Treatment Period II [Day 2, (8:30 am to 12:00 pm)]
Population: Only patients with valid TSC scores in Period II were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo (PBO) | Change From Baseline in the Total Symptom Complex (TSC) Score Over Period II | -5.73 units on a scale | Standard Error 0.917 |
| Levocetirizine (LCTZ) 2.5 mg | Change From Baseline in the Total Symptom Complex (TSC) Score Over Period II | -10.25 units on a scale | Standard Error 0.742 |
| Levocetirizine (LCTZ) 5 mg | Change From Baseline in the Total Symptom Complex (TSC) Score Over Period II | -11.03 units on a scale | Standard Error 0.739 |
| Cetirizine (CTZ) 5 mg | Change From Baseline in the Total Symptom Complex (TSC) Score Over Period II | -10.73 units on a scale | Standard Error 0.734 |
| Cetirizine (CTZ) 10 mg | Change From Baseline in the Total Symptom Complex (TSC) Score Over Period II | -12.14 units on a scale | Standard Error 0.736 |
Secondary
Change From Baseline in the Total Symptom Complex (TSC) Score Over the Total Treatment Period (Period I + Period II)
The TSC score was calculated as the sum of the following 10 individual symptom scores: runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip. Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The TSC score ranges from 0 to 56. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.
Time frame: Baseline to Day 2
Population: Only patients with valid TSC scores in Period I and II were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo (PBO) | Change From Baseline in the Total Symptom Complex (TSC) Score Over the Total Treatment Period (Period I + Period II) | -6.10 units on a scale | Standard Error 0.729 |
| Levocetirizine (LCTZ) 2.5 mg | Change From Baseline in the Total Symptom Complex (TSC) Score Over the Total Treatment Period (Period I + Period II) | -10.86 units on a scale | Standard Error 0.598 |
| Levocetirizine (LCTZ) 5 mg | Change From Baseline in the Total Symptom Complex (TSC) Score Over the Total Treatment Period (Period I + Period II) | -11.22 units on a scale | Standard Error 0.591 |
| Cetirizine (CTZ) 5 mg | Change From Baseline in the Total Symptom Complex (TSC) Score Over the Total Treatment Period (Period I + Period II) | -11.84 units on a scale | Standard Error 0.591 |
| Cetirizine (CTZ) 10 mg | Change From Baseline in the Total Symptom Complex (TSC) Score Over the Total Treatment Period (Period I + Period II) | -11.92 units on a scale | Standard Error 0.591 |