Rhinitis, Allergic, Seasonal
Conditions
Keywords
Levocetirizine, Xyzal, Rhinitis, Allergic, Seasonal, Ragweed
Brief summary
To compare the clinical efficacy of levocetirizine 5 mg and montelukast 10 mg on symptoms of seasonal allergic rhinitis occurring in subjects exposed to ragweed pollen in an environmental exposure unit.
Interventions
DRUGPlacebo
* Pharmaceutical form: Over-encapsulated tablet * Route of administration: Oral use
DRUGMontelukast
* Pharmaceutical form: Over-encapsulated tablet * Concentration: 10 mg * Route of administration: Oral use
DRUGLevocetirizine
* Pharmaceutical form: Over-encapsulated tablet * Concentration: 5 mg * Route of administration: Oral use
Sponsors
UCB S.A. - Pharma Sector
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have had seasonal allergic rhinitis due to Ragweed for the last 2 consecutive years * Subjects who obtain a minimum sum score, considering Seasonal Allergic Rhinitis (SAR) related symptoms (mean value), as defined by the 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 Period III | Baseline, Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 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 MSC Score Over the Total Treatment Period (Period I + Period II + Period III) | 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 1 [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, from 9:30 am to 11:00 am] | 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 III | Baseline, Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 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 the Total Treatment Period (Period I + Period II + Period III) | 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. |
| Change From Baseline in the TSC Score + Nasal Congestion 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)] | 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 Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. The TSC score plus Nasal congestion score was added and ranged from 0 to 60. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline. |
| Change From Baseline in the TSC Score + Nasal Congestion Score Over Period II | Baseline, Treatment Period II [Day 2, from 9:30 am to 11:00 am] | 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 Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. The TSC score plus Nasal congestion score was added and ranged from 0 to 60. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline. |
| Intensity of Action From Baseline in the MSC Score Over Period I | Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)] | The intensity of action was measured by the percentage of subjects with categorized percentage change from Baseline in the MSC score over Period I. Categories are defined as following: \< 20%, \>=20%, \< 50%, \>=50%, \< 70%, \>=70% change from Baseline. |
| Change From Baseline in the TSC Score + Nasal Congestion Score Over Period III | Baseline, Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 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 Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. The TSC score plus Nasal congestion score was added and ranged from 0 to 60. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline. |
| Change From Baseline in the TSC Score + Nasal Congestion Score Over the Total Treatment Period (Period I + Period II + Period III) | 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 Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. The TSC score plus Nasal congestion score was added and ranged from 0 to 60. 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, Postnasal Drip Score, Watery Eyes Score, Itchy Eyes and Ears Score, Itchy Throat Score, Cough Score, Sneezes Score, Nose Blows Score, Nasal Congestion 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. The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. 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, from 9:30 am to 11:00 am] | 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 III | Baseline, Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm] | Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Postnasal Drip Score, Watery Eyes Score, Itchy Eyes and Ears Score, Itchy Throat Score, Cough Score, Sneezes Score, Nose Blows Score, Nasal Congestion 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. The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. 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 + Period III) | Baseline to Day 2 | Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Postnasal Drip Score, Watery Eyes Score, Itchy Eyes and Ears Score, Itchy Throat Score, Cough Score, Sneezes Score, Nose Blows Score, Nasal Congestion 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. The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline. |
| Time to First Feeling of Improvement During Period I | During Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)] | During Period I, the subjects had to record the moment (hh:mm) of first feeling of improvement (compared to Baseline intensity of symptoms). |
| Onset of Action During Period I | During Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)] | The onset of action was defined as the first time point during Period I after initiation of the treatment when the reduction from Baseline in the MSC score for the active treatment group became statistically different from the placebo group and when this significant change was maintained for some period of time. |
| Intensity of Action From Baseline in the MSC Score Over Period II | Treatment Period II [Day 2, from 9:30 am to 11:00 am] | The intensity of action was measured by the percentage of subjects with categorized percentage change from Baseline in the MSC score over Period II. Categories are defined as following: \< 20%, \>=20%, \< 50%, \>=50%, \< 70%, \>=70% change from Baseline. |
| Intensity of Action From Baseline in the MSC Score Over Period III | Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm] | The intensity of action was measured by the percentage of subjects with categorized percentage change from Baseline in the MSC score over Period III. Categories are defined as following: \< 20%, \>=20%, \< 50%, \>=50%, \< 70%, \>=70% change from Baseline. |
| Variability of Action From Baseline in the MSC Score Over Period I | Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)] | The variability of action was assessed by the percentage of distribution of the percentage change from Baseline in the MSC score. Categories are defined as following: \< 20%, 20%-35%, 35%-50%, 50%-65%, 65%-80%, \>=80%. |
| Variability of Action From Baseline in the MSC Score Over Period II | Treatment Period II [Day 2, from 9:30 am to 11:00 am] | The variability of action was assessed by the percentage of distribution of the percentage change from Baseline in the MSC score. Categories are defined as following: \< 20%, 20%-35%, 35%-50%, 50%-65%, 65%-80%, \>=80%. |
| Variability of Action From Baseline in the MSC Score Over Period III | Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm] | The variability of action was assessed by the percentage of distribution of the percentage change from Baseline in the MSC score. Categories are defined as following: \< 20%, 20%-35%, 35%-50%, 50%-65%, 65%-80%, \>=80%. |
| Global Satisfaction of the Subjects at the End of Period III | At the end of Period III (Day 2) | Global satisfaction was evaluated at the end of Period III by the subject on a Visual Analog Scale (VAS) ranging from 0 (very dissatisfied) to 100 mm (very satisfied). |
| Percentage of Subjects, at the End of Period III Who Are Willing to Take the Same Medication During the Next Pollen Season | At the end of Period III (Day 2) | At the end of Period III, each subject without reference to the Symptom Diary Card (SDC) answered to the question: Do you want to take the same treatment during the next pollen season? (yes or no). |
| Change From Baseline in the Individual Symptom Scores Over Period II | Baseline, Treatment Period II [Day 2, from 9:30 am to 11:00 am] | Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Postnasal Drip Score, Watery Eyes Score, Itchy Eyes and Ears Score, Itchy Throat Score, Cough Score, Sneezes Score, Nose Blows Score, Nasal Congestion 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. The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline. |
Countries
Canada
Participant flow
Pre-assignment details
Participant Flow refers to the Randomized Set.
Participants by arm
| Arm | Count |
|---|---|
| Placebo (PBO) Placebo was administered orally on Days 1 and 2. | 105 |
| Levocetirizine (LCTZ) 5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2. | 157 |
| Montelukast (MLKT) 10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2. | 156 |
| Total Title | 418 |
| Total | 836 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 | 2 |
| Overall Study | Lost to Follow-up | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 2 |
Baseline characteristics
| Characteristic | Placebo (PBO) | Levocetirizine (LCTZ) | Montelukast (MLKT) | Total Title |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 2 Participants | 0 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 104 Participants | 155 Participants | 156 Participants | 415 Participants |
| Age, Continuous | 35.41 years STANDARD_DEVIATION 11.74 | 34.95 years STANDARD_DEVIATION 11.98 | 32.98 years STANDARD_DEVIATION 11.72 | 34.33 years STANDARD_DEVIATION 11.85 |
| Sex: Female, Male Female | 60 Participants | 101 Participants | 89 Participants | 250 Participants |
| Sex: Female, Male Male | 45 Participants | 56 Participants | 67 Participants | 168 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 105 | 0 / 157 | 0 / 156 |
| other Total, other adverse events | 9 / 105 | 13 / 157 | 18 / 156 |
| serious Total, serious adverse events | 0 / 105 | 0 / 157 | 0 / 156 |
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: Efficacy variables were analyzed using the Intention-To-Treat (ITT) population. ITT consists of all randomized subjects who took at least one dose of study medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo (PBO) | Change From Baseline in the Major Symptom Complex (MSC) Score Over Period I | -3.46 units on a scale | Standard Error 0.49 |
| Levocetirizine (LCTZ) | Change From Baseline in the Major Symptom Complex (MSC) Score Over Period I | -6.58 units on a scale | Standard Error 0.4 |
| Montelukast (MLKT) | Change From Baseline in the Major Symptom Complex (MSC) Score Over Period I | -5.65 units on a scale | Standard Error 0.4 |
p-value: <0.00195% CI: [-4.35, -1.88]ANCOVA
p-value: =0.00195% CI: [-2.04, 0.18]ANCOVA
p-value: <0.00195% CI: [-3.43, -0.95]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, Postnasal Drip Score, Watery Eyes Score, Itchy Eyes and Ears Score, Itchy Throat Score, Cough Score, Sneezes Score, Nose Blows Score, Nasal Congestion 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. The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. 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 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 | Cough Score | -0.71 units on a scale | Standard Error 0.06 |
| Placebo (PBO) | Change From Baseline in the Individual Symptom Scores Over Period I | Watery Eyes Score | -0.58 units on a scale | Standard Error 0.09 |
| Placebo (PBO) | Change From Baseline in the Individual Symptom Scores Over Period I | Nose Blows Score | -1.03 units on a scale | Standard Error 0.13 |
| Placebo (PBO) | Change From Baseline in the Individual Symptom Scores Over Period I | Itchy Throat Score | -0.66 units on a scale | Standard Error 0.09 |
| Placebo (PBO) | Change From Baseline in the Individual Symptom Scores Over Period I | Itchy Eyes/Ears Score | -0.69 units on a scale | Standard Error 0.09 |
| Placebo (PBO) | Change From Baseline in the Individual Symptom Scores Over Period I | Runny Nose Score | -0.55 units on a scale | Standard Error 0.09 |
| Placebo (PBO) | Change From Baseline in the Individual Symptom Scores Over Period I | Sniffles Score | -0.53 units on a scale | Standard Error 0.09 |
| Placebo (PBO) | Change From Baseline in the Individual Symptom Scores Over Period I | Itchy Nose Score | -0.52 units on a scale | Standard Error 0.09 |
| Placebo (PBO) | Change From Baseline in the Individual Symptom Scores Over Period I | Sneezes Score | -0.28 units on a scale | Standard Error 0.11 |
| Placebo (PBO) | Change From Baseline in the Individual Symptom Scores Over Period I | Postnasal Drip Score | -0.65 units on a scale | Standard Error 0.1 |
| Placebo (PBO) | Change From Baseline in the Individual Symptom Scores Over Period I | Nasal Congestion Score | -0.41 units on a scale | Standard Error 0.07 |
| Levocetirizine (LCTZ) | Change From Baseline in the Individual Symptom Scores Over Period I | Itchy Eyes/Ears Score | -1.14 units on a scale | Standard Error 0.08 |
| Levocetirizine (LCTZ) | Change From Baseline in the Individual Symptom Scores Over Period I | Runny Nose Score | -0.89 units on a scale | Standard Error 0.07 |
| Levocetirizine (LCTZ) | Change From Baseline in the Individual Symptom Scores Over Period I | Itchy Nose Score | -0.93 units on a scale | Standard Error 0.08 |
| Levocetirizine (LCTZ) | Change From Baseline in the Individual Symptom Scores Over Period I | Sniffles Score | -0.93 units on a scale | Standard Error 0.08 |
| Levocetirizine (LCTZ) | Change From Baseline in the Individual Symptom Scores Over Period I | Postnasal Drip Score | -0.99 units on a scale | Standard Error 0.08 |
| Levocetirizine (LCTZ) | Change From Baseline in the Individual Symptom Scores Over Period I | Watery Eyes Score | -0.94 units on a scale | Standard Error 0.07 |
| Levocetirizine (LCTZ) | Change From Baseline in the Individual Symptom Scores Over Period I | Itchy Throat Score | -1.00 units on a scale | Standard Error 0.07 |
| Levocetirizine (LCTZ) | Change From Baseline in the Individual Symptom Scores Over Period I | Cough Score | -0.81 units on a scale | Standard Error 0.05 |
| Levocetirizine (LCTZ) | Change From Baseline in the Individual Symptom Scores Over Period I | Sneezes Score | -1.07 units on a scale | Standard Error 0.09 |
| Levocetirizine (LCTZ) | Change From Baseline in the Individual Symptom Scores Over Period I | Nose Blows Score | -1.77 units on a scale | Standard Error 0.1 |
| Levocetirizine (LCTZ) | Change From Baseline in the Individual Symptom Scores Over Period I | Nasal Congestion Score | -0.62 units on a scale | Standard Error 0.06 |
| Montelukast (MLKT) | Change From Baseline in the Individual Symptom Scores Over Period I | Nose Blows Score | -1.59 units on a scale | Standard Error 0.1 |
| Montelukast (MLKT) | Change From Baseline in the Individual Symptom Scores Over Period I | Cough Score | -0.71 units on a scale | Standard Error 0.05 |
| Montelukast (MLKT) | Change From Baseline in the Individual Symptom Scores Over Period I | Sniffles Score | -0.87 units on a scale | Standard Error 0.08 |
| Montelukast (MLKT) | Change From Baseline in the Individual Symptom Scores Over Period I | Runny Nose Score | -0.86 units on a scale | Standard Error 0.07 |
| Montelukast (MLKT) | Change From Baseline in the Individual Symptom Scores Over Period I | Sneezes Score | -0.68 units on a scale | Standard Error 0.09 |
| Montelukast (MLKT) | Change From Baseline in the Individual Symptom Scores Over Period I | Itchy Nose Score | -0.85 units on a scale | Standard Error 0.08 |
| Montelukast (MLKT) | Change From Baseline in the Individual Symptom Scores Over Period I | Itchy Eyes/Ears Score | -0.90 units on a scale | Standard Error 0.08 |
| Montelukast (MLKT) | Change From Baseline in the Individual Symptom Scores Over Period I | Watery Eyes Score | -0.82 units on a scale | Standard Error 0.07 |
| Montelukast (MLKT) | Change From Baseline in the Individual Symptom Scores Over Period I | Nasal Congestion Score | -0.64 units on a scale | Standard Error 0.06 |
| Montelukast (MLKT) | Change From Baseline in the Individual Symptom Scores Over Period I | Itchy Throat Score | -0.85 units on a scale | Standard Error 0.07 |
| Montelukast (MLKT) | Change From Baseline in the Individual Symptom Scores Over Period I | Postnasal Drip Score | -0.89 units on a scale | Standard Error 0.08 |
Secondary
Change From Baseline in the Individual Symptom Scores Over Period II
Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Postnasal Drip Score, Watery Eyes Score, Itchy Eyes and Ears Score, Itchy Throat Score, Cough Score, Sneezes Score, Nose Blows Score, Nasal Congestion 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. The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.
Time frame: Baseline, Treatment Period II [Day 2, from 9:30 am to 11:00 am]
Population: Only patients 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 | Cough Score | -0.49 units on a scale | Standard Error 0.08 |
| Placebo (PBO) | Change From Baseline in the Individual Symptom Scores Over Period II | Watery Eyes Score | -0.20 units on a scale | Standard Error 0.11 |
| Placebo (PBO) | Change From Baseline in the Individual Symptom Scores Over Period II | Nose Blows Score | -0.38 units on a scale | Standard Error 0.15 |
| Placebo (PBO) | Change From Baseline in the Individual Symptom Scores Over Period II | Itchy Throat Score | -0.19 units on a scale | Standard Error 0.1 |
| Placebo (PBO) | Change From Baseline in the Individual Symptom Scores Over Period II | Itchy Eyes/Ears Score | -0.18 units on a scale | Standard Error 0.1 |
| Placebo (PBO) | Change From Baseline in the Individual Symptom Scores Over Period II | Runny Nose Score | -0.18 units on a scale | Standard Error 0.09 |
| Placebo (PBO) | Change From Baseline in the Individual Symptom Scores Over Period II | Sniffles Score | -0.10 units on a scale | Standard Error 0.09 |
| Placebo (PBO) | Change From Baseline in the Individual Symptom Scores Over Period II | Itchy Nose Score | -0.22 units on a scale | Standard Error 0.09 |
| Placebo (PBO) | Change From Baseline in the Individual Symptom Scores Over Period II | Sneezes Score | -0.19 units on a scale | Standard Error 0.14 |
| Placebo (PBO) | Change From Baseline in the Individual Symptom Scores Over Period II | Postnasal Drip Score | -0.37 units on a scale | Standard Error 0.09 |
| Placebo (PBO) | Change From Baseline in the Individual Symptom Scores Over Period II | Nasal Congestion Score | -0.19 units on a scale | Standard Error 0.07 |
| Levocetirizine (LCTZ) | Change From Baseline in the Individual Symptom Scores Over Period II | Itchy Eyes/Ears Score | -0.81 units on a scale | Standard Error 0.08 |
| Levocetirizine (LCTZ) | Change From Baseline in the Individual Symptom Scores Over Period II | Runny Nose Score | -0.85 units on a scale | Standard Error 0.08 |
| Levocetirizine (LCTZ) | Change From Baseline in the Individual Symptom Scores Over Period II | Itchy Nose Score | -0.84 units on a scale | Standard Error 0.07 |
| Levocetirizine (LCTZ) | Change From Baseline in the Individual Symptom Scores Over Period II | Sniffles Score | -0.83 units on a scale | Standard Error 0.08 |
| Levocetirizine (LCTZ) | Change From Baseline in the Individual Symptom Scores Over Period II | Postnasal Drip Score | -0.90 units on a scale | Standard Error 0.08 |
| Levocetirizine (LCTZ) | Change From Baseline in the Individual Symptom Scores Over Period II | Watery Eyes Score | -0.66 units on a scale | Standard Error 0.09 |
| Levocetirizine (LCTZ) | Change From Baseline in the Individual Symptom Scores Over Period II | Itchy Throat Score | -0.78 units on a scale | Standard Error 0.08 |
| Levocetirizine (LCTZ) | Change From Baseline in the Individual Symptom Scores Over Period II | Cough Score | -0.70 units on a scale | Standard Error 0.06 |
| Levocetirizine (LCTZ) | Change From Baseline in the Individual Symptom Scores Over Period II | Sneezes Score | -1.28 units on a scale | Standard Error 0.11 |
| Levocetirizine (LCTZ) | Change From Baseline in the Individual Symptom Scores Over Period II | Nose Blows Score | -1.84 units on a scale | Standard Error 0.13 |
| Levocetirizine (LCTZ) | Change From Baseline in the Individual Symptom Scores Over Period II | Nasal Congestion Score | -0.43 units on a scale | Standard Error 0.05 |
| Montelukast (MLKT) | Change From Baseline in the Individual Symptom Scores Over Period II | Nose Blows Score | -0.99 units on a scale | Standard Error 0.13 |
| Montelukast (MLKT) | Change From Baseline in the Individual Symptom Scores Over Period II | Cough Score | -0.58 units on a scale | Standard Error 0.06 |
| Montelukast (MLKT) | Change From Baseline in the Individual Symptom Scores Over Period II | Sniffles Score | -0.48 units on a scale | Standard Error 0.08 |
| Montelukast (MLKT) | Change From Baseline in the Individual Symptom Scores Over Period II | Runny Nose Score | -0.53 units on a scale | Standard Error 0.08 |
| Montelukast (MLKT) | Change From Baseline in the Individual Symptom Scores Over Period II | Sneezes Score | -0.40 units on a scale | Standard Error 0.12 |
| Montelukast (MLKT) | Change From Baseline in the Individual Symptom Scores Over Period II | Itchy Nose Score | -0.40 units on a scale | Standard Error 0.08 |
| Montelukast (MLKT) | Change From Baseline in the Individual Symptom Scores Over Period II | Itchy Eyes/Ears Score | -0.40 units on a scale | Standard Error 0.09 |
| Montelukast (MLKT) | Change From Baseline in the Individual Symptom Scores Over Period II | Watery Eyes Score | -0.46 units on a scale | Standard Error 0.09 |
| Montelukast (MLKT) | Change From Baseline in the Individual Symptom Scores Over Period II | Nasal Congestion Score | -0.35 units on a scale | Standard Error 0.06 |
| Montelukast (MLKT) | Change From Baseline in the Individual Symptom Scores Over Period II | Itchy Throat Score | -0.39 units on a scale | Standard Error 0.09 |
| Montelukast (MLKT) | Change From Baseline in the Individual Symptom Scores Over Period II | Postnasal Drip Score | -0.52 units on a scale | Standard Error 0.08 |
Secondary
Change From Baseline in the Individual Symptom Scores Over Period III
Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Postnasal Drip Score, Watery Eyes Score, Itchy Eyes and Ears Score, Itchy Throat Score, Cough Score, Sneezes Score, Nose Blows Score, Nasal Congestion 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. The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.
Time frame: Baseline, Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm]
Population: Only patients with valid individual symptom scores in Period III 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 III | Cough Score | -0.78 units on a scale | Standard Error 0.07 |
| Placebo (PBO) | Change From Baseline in the Individual Symptom Scores Over Period III | Watery Eyes Score | -0.36 units on a scale | Standard Error 0.11 |
| Placebo (PBO) | Change From Baseline in the Individual Symptom Scores Over Period III | Nose Blows Score | -1.22 units on a scale | Standard Error 0.15 |
| Placebo (PBO) | Change From Baseline in the Individual Symptom Scores Over Period III | Itchy Throat Score | -0.54 units on a scale | Standard Error 0.11 |
| Placebo (PBO) | Change From Baseline in the Individual Symptom Scores Over Period III | Itchy Eyes/Ears Score | -0.42 units on a scale | Standard Error 0.12 |
| Placebo (PBO) | Change From Baseline in the Individual Symptom Scores Over Period III | Runny Nose Score | -0.52 units on a scale | Standard Error 0.11 |
| Placebo (PBO) | Change From Baseline in the Individual Symptom Scores Over Period III | Sniffles Score | -0.50 units on a scale | Standard Error 0.11 |
| Placebo (PBO) | Change From Baseline in the Individual Symptom Scores Over Period III | Itchy Nose Score | -0.47 units on a scale | Standard Error 0.11 |
| Placebo (PBO) | Change From Baseline in the Individual Symptom Scores Over Period III | Sneezes Score | -0.48 units on a scale | Standard Error 0.12 |
| Placebo (PBO) | Change From Baseline in the Individual Symptom Scores Over Period III | Postnasal Drip Score | -0.67 units on a scale | Standard Error 0.11 |
| Placebo (PBO) | Change From Baseline in the Individual Symptom Scores Over Period III | Nasal Congestion Score | -0.43 units on a scale | Standard Error 0.08 |
| Levocetirizine (LCTZ) | Change From Baseline in the Individual Symptom Scores Over Period III | Itchy Eyes/Ears Score | -1.34 units on a scale | Standard Error 0.1 |
| Levocetirizine (LCTZ) | Change From Baseline in the Individual Symptom Scores Over Period III | Runny Nose Score | -1.23 units on a scale | Standard Error 0.09 |
| Levocetirizine (LCTZ) | Change From Baseline in the Individual Symptom Scores Over Period III | Itchy Nose Score | -1.25 units on a scale | Standard Error 0.09 |
| Levocetirizine (LCTZ) | Change From Baseline in the Individual Symptom Scores Over Period III | Sniffles Score | -1.26 units on a scale | Standard Error 0.09 |
| Levocetirizine (LCTZ) | Change From Baseline in the Individual Symptom Scores Over Period III | Postnasal Drip Score | -1.32 units on a scale | Standard Error 0.09 |
| Levocetirizine (LCTZ) | Change From Baseline in the Individual Symptom Scores Over Period III | Watery Eyes Score | -1.11 units on a scale | Standard Error 0.09 |
| Levocetirizine (LCTZ) | Change From Baseline in the Individual Symptom Scores Over Period III | Itchy Throat Score | -1.15 units on a scale | Standard Error 0.09 |
| Levocetirizine (LCTZ) | Change From Baseline in the Individual Symptom Scores Over Period III | Cough Score | -0.97 units on a scale | Standard Error 0.06 |
| Levocetirizine (LCTZ) | Change From Baseline in the Individual Symptom Scores Over Period III | Sneezes Score | -1.40 units on a scale | Standard Error 0.1 |
| Levocetirizine (LCTZ) | Change From Baseline in the Individual Symptom Scores Over Period III | Nose Blows Score | -2.32 units on a scale | Standard Error 0.12 |
| Levocetirizine (LCTZ) | Change From Baseline in the Individual Symptom Scores Over Period III | Nasal Congestion Score | -0.79 units on a scale | Standard Error 0.06 |
| Montelukast (MLKT) | Change From Baseline in the Individual Symptom Scores Over Period III | Nose Blows Score | -1.82 units on a scale | Standard Error 0.13 |
| Montelukast (MLKT) | Change From Baseline in the Individual Symptom Scores Over Period III | Cough Score | -0.84 units on a scale | Standard Error 0.06 |
| Montelukast (MLKT) | Change From Baseline in the Individual Symptom Scores Over Period III | Sniffles Score | -0.96 units on a scale | Standard Error 0.09 |
| Montelukast (MLKT) | Change From Baseline in the Individual Symptom Scores Over Period III | Runny Nose Score | -0.93 units on a scale | Standard Error 0.09 |
| Montelukast (MLKT) | Change From Baseline in the Individual Symptom Scores Over Period III | Sneezes Score | -0.78 units on a scale | Standard Error 0.1 |
| Montelukast (MLKT) | Change From Baseline in the Individual Symptom Scores Over Period III | Itchy Nose Score | -0.89 units on a scale | Standard Error 0.09 |
| Montelukast (MLKT) | Change From Baseline in the Individual Symptom Scores Over Period III | Itchy Eyes/Ears Score | -0.87 units on a scale | Standard Error 0.1 |
| Montelukast (MLKT) | Change From Baseline in the Individual Symptom Scores Over Period III | Watery Eyes Score | -0.84 units on a scale | Standard Error 0.09 |
| Montelukast (MLKT) | Change From Baseline in the Individual Symptom Scores Over Period III | Nasal Congestion Score | -0.67 units on a scale | Standard Error 0.07 |
| Montelukast (MLKT) | Change From Baseline in the Individual Symptom Scores Over Period III | Itchy Throat Score | -0.86 units on a scale | Standard Error 0.09 |
| Montelukast (MLKT) | Change From Baseline in the Individual Symptom Scores Over Period III | Postnasal Drip Score | -0.97 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 + Period III)
Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Postnasal Drip Score, Watery Eyes Score, Itchy Eyes and Ears Score, Itchy Throat Score, Cough Score, Sneezes Score, Nose Blows Score, Nasal Congestion 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. The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.
Time frame: Baseline to Day 2
Population: Only patients with valid individual symptom scores during the Total Treatment Period 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 + Period III) | Cough Score | -0.71 units on a scale | Standard Error 0.06 |
| Placebo (PBO) | Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II + Period III) | Watery Eyes Score | -0.44 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 + Period III) | Nose Blows Score | -1.02 units on a scale | Standard Error 0.12 |
| Placebo (PBO) | Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II + Period III) | Itchy Throat Score | -0.54 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 + Period III) | Itchy Eyes/Ears Score | -0.51 units on a scale | Standard Error 0.1 |
| Placebo (PBO) | Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II + Period III) | Runny Nose Score | -0.48 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 + Period III) | Sniffles Score | -0.45 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 + Period III) | Itchy Nose Score | -0.46 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 + Period III) | Sneezes Score | -0.35 units on a scale | Standard Error 0.1 |
| Placebo (PBO) | Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II + Period III) | Postnasal Drip Score | -0.62 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 + Period III) | Nasal Congestion Score | -0.38 units on a scale | Standard Error 0.07 |
| Levocetirizine (LCTZ) | Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II + Period III) | Itchy Eyes/Ears Score | -1.17 units on a scale | Standard Error 0.08 |
| Levocetirizine (LCTZ) | Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II + Period III) | Runny Nose Score | -1.02 units on a scale | Standard Error 0.07 |
| Levocetirizine (LCTZ) | Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II + Period III) | Itchy Nose Score | -1.05 units on a scale | Standard Error 0.07 |
| Levocetirizine (LCTZ) | Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II + Period III) | Sniffles Score | -1.05 units on a scale | Standard Error 0.07 |
| Levocetirizine (LCTZ) | Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II + Period III) | Postnasal Drip Score | -1.11 units on a scale | Standard Error 0.07 |
| Levocetirizine (LCTZ) | Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II + Period III) | Watery Eyes Score | -0.97 units on a scale | Standard Error 0.07 |
| Levocetirizine (LCTZ) | Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II + Period III) | Itchy Throat Score | -1.03 units on a scale | Standard Error 0.07 |
| Levocetirizine (LCTZ) | Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II + Period III) | Cough Score | -0.86 units on a scale | Standard Error 0.05 |
| Levocetirizine (LCTZ) | Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II + Period III) | Sneezes Score | -1.23 units on a scale | Standard Error 0.08 |
| Levocetirizine (LCTZ) | Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II + Period III) | Nose Blows Score | -2.00 units on a scale | Standard Error 0.1 |
| Levocetirizine (LCTZ) | Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II + Period III) | Nasal Congestion Score | -0.67 units on a scale | Standard Error 0.05 |
| Montelukast (MLKT) | Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II + Period III) | Nose Blows Score | -1.58 units on a scale | Standard Error 0.1 |
| Montelukast (MLKT) | Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II + Period III) | Cough Score | -0.74 units on a scale | Standard Error 0.05 |
| Montelukast (MLKT) | Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II + Period III) | Sniffles Score | -0.85 units on a scale | Standard Error 0.07 |
| Montelukast (MLKT) | Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II + Period III) | Runny Nose Score | -0.84 units on a scale | Standard Error 0.07 |
| Montelukast (MLKT) | Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II + Period III) | Sneezes Score | -0.67 units on a scale | Standard Error 0.08 |
| Montelukast (MLKT) | Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II + Period III) | Itchy Nose Score | -0.79 units on a scale | Standard Error 0.07 |
| Montelukast (MLKT) | Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II + Period III) | Itchy Eyes/Ears Score | -0.81 units on a scale | Standard Error 0.08 |
| Montelukast (MLKT) | Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II + Period III) | Watery Eyes Score | -0.77 units on a scale | Standard Error 0.07 |
| Montelukast (MLKT) | Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II + Period III) | Nasal Congestion Score | -0.61 units on a scale | Standard Error 0.05 |
| Montelukast (MLKT) | Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II + Period III) | Itchy Throat Score | -0.78 units on a scale | Standard Error 0.07 |
| Montelukast (MLKT) | Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II + Period III) | Postnasal Drip Score | -0.87 units on a scale | Standard Error 0.07 |
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, from 9:30 am to 11:00 am]
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 | -1.22 units on a scale | Standard Error 0.52 |
| Levocetirizine (LCTZ) | Change From Baseline in the MSC Score Over Period II | -6.35 units on a scale | Standard Error 0.42 |
| Montelukast (MLKT) | Change From Baseline in the MSC Score Over Period II | -3.24 units on a scale | Standard Error 0.43 |
Secondary
Change From Baseline in the MSC Score Over Period III
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 III [Day 2, from drug intake (at 11:00 am) to 3:30 pm]
Population: Only patients with valid MSC scores in Period III were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo (PBO) | Change From Baseline in the MSC Score Over Period III | -3.50 units on a scale | Standard Error 0.58 |
| Levocetirizine (LCTZ) | Change From Baseline in the MSC Score Over Period III | -8.62 units on a scale | Standard Error 0.47 |
| Montelukast (MLKT) | Change From Baseline in the MSC Score Over Period III | -6.19 units on a scale | Standard Error 0.48 |
Secondary
Change From Baseline in the MSC Score Over the Total Treatment Period (Period I + Period II + Period III)
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 during the Total Treatment Period 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 + Period III) | -3.16 units on a scale | Standard Error 0.46 |
| Levocetirizine (LCTZ) | Change From Baseline in the MSC Score Over the Total Treatment Period (Period I + Period II + Period III) | -7.37 units on a scale | Standard Error 0.38 |
| Montelukast (MLKT) | Change From Baseline in the MSC Score Over the Total Treatment Period (Period I + Period II + Period III) | -5.48 units on a scale | Standard Error 0.38 |
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 1 [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 | -6.16 units on a scale | Standard Error 0.75 |
| Levocetirizine (LCTZ) | Change From Baseline in the Total Symptom Complex (TSC) Score Over Period I | -10.53 units on a scale | Standard Error 0.61 |
| Montelukast (MLKT) | Change From Baseline in the Total Symptom Complex (TSC) Score Over Period I | -9.01 units on a scale | Standard Error 0.61 |
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, from 9:30 am to 11:00 am]
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 | -2.45 units on a scale | Standard Error 0.76 |
| Levocetirizine (LCTZ) | Change From Baseline in the Total Symptom Complex (TSC) Score Over Period II | -9.54 units on a scale | Standard Error 0.62 |
| Montelukast (MLKT) | Change From Baseline in the Total Symptom Complex (TSC) Score Over Period II | -5.12 units on a scale | Standard Error 0.63 |
Secondary
Change From Baseline in the Total Symptom Complex (TSC) Score Over Period III
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 III [Day 2, from drug intake (at 11:00 am) to 3:30 pm]
Population: Only patients with valid TSC scores in Period III 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 III | -5.91 units on a scale | Standard Error 0.88 |
| Levocetirizine (LCTZ) | Change From Baseline in the Total Symptom Complex (TSC) Score Over Period III | -13.39 units on a scale | Standard Error 0.72 |
| Montelukast (MLKT) | Change From Baseline in the Total Symptom Complex (TSC) Score Over Period III | -9.73 units on a scale | Standard Error 0.73 |
Secondary
Change From Baseline in the Total Symptom Complex (TSC) Score Over the Total Treatment Period (Period I + Period II + Period III)
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 during the Total Treatment Period 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 + Period III) | -5.53 units on a scale | Standard Error 0.72 |
| Levocetirizine (LCTZ) | Change From Baseline in the Total Symptom Complex (TSC) Score Over the Total Treatment Period (Period I + Period II + Period III) | -11.54 units on a scale | Standard Error 0.59 |
| Montelukast (MLKT) | Change From Baseline in the Total Symptom Complex (TSC) Score Over the Total Treatment Period (Period I + Period II + Period III) | -8.68 units on a scale | Standard Error 0.59 |
Secondary
Change From Baseline in the TSC Score + Nasal Congestion 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 Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. The TSC score plus Nasal congestion score was added and ranged from 0 to 60. 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 TSC score + Nasal congestion score in Period I were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo (PBO) | Change From Baseline in the TSC Score + Nasal Congestion Score Over Period I | -6.57 units on a scale | Standard Error 0.8 |
| Levocetirizine (LCTZ) | Change From Baseline in the TSC Score + Nasal Congestion Score Over Period I | -11.15 units on a scale | Standard Error 0.66 |
| Montelukast (MLKT) | Change From Baseline in the TSC Score + Nasal Congestion Score Over Period I | -9.65 units on a scale | Standard Error 0.66 |
Secondary
Change From Baseline in the TSC Score + Nasal Congestion 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 Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. The TSC score plus Nasal congestion score was added and ranged from 0 to 60. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.
Time frame: Baseline, Treatment Period II [Day 2, from 9:30 am to 11:00 am]
Population: Only patients with valid TSC score + Nasal congestion score in Period II were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo (PBO) | Change From Baseline in the TSC Score + Nasal Congestion Score Over Period II | -2.65 units on a scale | Standard Error 0.8 |
| Levocetirizine (LCTZ) | Change From Baseline in the TSC Score + Nasal Congestion Score Over Period II | -9.97 units on a scale | Standard Error 0.65 |
| Montelukast (MLKT) | Change From Baseline in the TSC Score + Nasal Congestion Score Over Period II | -5.47 units on a scale | Standard Error 0.66 |
Secondary
Change From Baseline in the TSC Score + Nasal Congestion Score Over Period III
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 Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. The TSC score plus Nasal congestion score was added and ranged from 0 to 60. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.
Time frame: Baseline, Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm]
Population: Only patients with valid TSC score + Nasal congestion score in Period III were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo (PBO) | Change From Baseline in the TSC Score + Nasal Congestion Score Over Period III | -6.35 units on a scale | Standard Error 0.94 |
| Levocetirizine (LCTZ) | Change From Baseline in the TSC Score + Nasal Congestion Score Over Period III | -14.18 units on a scale | Standard Error 0.77 |
| Montelukast (MLKT) | Change From Baseline in the TSC Score + Nasal Congestion Score Over Period III | -10.39 units on a scale | Standard Error 0.78 |
Secondary
Change From Baseline in the TSC Score + Nasal Congestion Score Over the Total Treatment Period (Period I + Period II + Period III)
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 Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. The TSC score plus Nasal congestion score was added and ranged from 0 to 60. 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 score + Nasal congestion score during the Total Treatment Period were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo (PBO) | Change From Baseline in the TSC Score + Nasal Congestion Score Over the Total Treatment Period (Period I + Period II + Period III) | -5.92 units on a scale | Standard Error 0.77 |
| Levocetirizine (LCTZ) | Change From Baseline in the TSC Score + Nasal Congestion Score Over the Total Treatment Period (Period I + Period II + Period III) | -12.21 units on a scale | Standard Error 0.63 |
| Montelukast (MLKT) | Change From Baseline in the TSC Score + Nasal Congestion Score Over the Total Treatment Period (Period I + Period II + Period III) | -9.28 units on a scale | Standard Error 0.63 |
Secondary
Global Satisfaction of the Subjects at the End of Period III
Global satisfaction was evaluated at the end of Period III by the subject on a Visual Analog Scale (VAS) ranging from 0 (very dissatisfied) to 100 mm (very satisfied).
Time frame: At the end of Period III (Day 2)
Population: Only subjects with valid data for Global Satisfaction (VAS Score) were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo (PBO) | Global Satisfaction of the Subjects at the End of Period III | 32.42 units on a scale | Standard Deviation 31.05 |
| Levocetirizine (LCTZ) | Global Satisfaction of the Subjects at the End of Period III | 53.94 units on a scale | Standard Deviation 32.95 |
| Montelukast (MLKT) | Global Satisfaction of the Subjects at the End of Period III | 41.80 units on a scale | Standard Deviation 32.1 |
Secondary
Intensity of Action From Baseline in the MSC Score Over Period I
The intensity of action was measured by the percentage of subjects with categorized percentage change from Baseline in the MSC score over Period I. Categories are defined as following: \< 20%, \>=20%, \< 50%, \>=50%, \< 70%, \>=70% change from Baseline.
Time frame: Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo (PBO) | Intensity of Action From Baseline in the MSC Score Over Period I | < 20% | 54.3 percentage of participants |
| Placebo (PBO) | Intensity of Action From Baseline in the MSC Score Over Period I | >= 20% | 45.7 percentage of participants |
| Placebo (PBO) | Intensity of Action From Baseline in the MSC Score Over Period I | < 50% | 80.0 percentage of participants |
| Placebo (PBO) | Intensity of Action From Baseline in the MSC Score Over Period I | >= 50% | 20.0 percentage of participants |
| Placebo (PBO) | Intensity of Action From Baseline in the MSC Score Over Period I | < 70% | 95.2 percentage of participants |
| Placebo (PBO) | Intensity of Action From Baseline in the MSC Score Over Period I | >= 70% | 4.8 percentage of participants |
| Levocetirizine (LCTZ) | Intensity of Action From Baseline in the MSC Score Over Period I | >= 70% | 12.1 percentage of participants |
| Levocetirizine (LCTZ) | Intensity of Action From Baseline in the MSC Score Over Period I | < 20% | 21.0 percentage of participants |
| Levocetirizine (LCTZ) | Intensity of Action From Baseline in the MSC Score Over Period I | >= 50% | 31.2 percentage of participants |
| Levocetirizine (LCTZ) | Intensity of Action From Baseline in the MSC Score Over Period I | < 70% | 87.9 percentage of participants |
| Levocetirizine (LCTZ) | Intensity of Action From Baseline in the MSC Score Over Period I | >= 20% | 79.0 percentage of participants |
| Levocetirizine (LCTZ) | Intensity of Action From Baseline in the MSC Score Over Period I | < 50% | 68.8 percentage of participants |
| Montelukast (MLKT) | Intensity of Action From Baseline in the MSC Score Over Period I | >= 20% | 67.3 percentage of participants |
| Montelukast (MLKT) | Intensity of Action From Baseline in the MSC Score Over Period I | < 50% | 67.9 percentage of participants |
| Montelukast (MLKT) | Intensity of Action From Baseline in the MSC Score Over Period I | >= 70% | 7.7 percentage of participants |
| Montelukast (MLKT) | Intensity of Action From Baseline in the MSC Score Over Period I | >= 50% | 32.1 percentage of participants |
| Montelukast (MLKT) | Intensity of Action From Baseline in the MSC Score Over Period I | < 20% | 32.7 percentage of participants |
| Montelukast (MLKT) | Intensity of Action From Baseline in the MSC Score Over Period I | < 70% | 92.3 percentage of participants |
Secondary
Intensity of Action From Baseline in the MSC Score Over Period II
The intensity of action was measured by the percentage of subjects with categorized percentage change from Baseline in the MSC score over Period II. Categories are defined as following: \< 20%, \>=20%, \< 50%, \>=50%, \< 70%, \>=70% change from Baseline.
Time frame: Treatment Period II [Day 2, from 9:30 am to 11:00 am]
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo (PBO) | Intensity of Action From Baseline in the MSC Score Over Period II | < 20% | 67.3 percentage of participants |
| Placebo (PBO) | Intensity of Action From Baseline in the MSC Score Over Period II | >= 20% | 32.7 percentage of participants |
| Placebo (PBO) | Intensity of Action From Baseline in the MSC Score Over Period II | < 50% | 93.3 percentage of participants |
| Placebo (PBO) | Intensity of Action From Baseline in the MSC Score Over Period II | >= 50% | 6.7 percentage of participants |
| Placebo (PBO) | Intensity of Action From Baseline in the MSC Score Over Period II | < 70% | 98.1 percentage of participants |
| Placebo (PBO) | Intensity of Action From Baseline in the MSC Score Over Period II | >= 70% | 1.9 percentage of participants |
| Levocetirizine (LCTZ) | Intensity of Action From Baseline in the MSC Score Over Period II | >= 70% | 16.7 percentage of participants |
| Levocetirizine (LCTZ) | Intensity of Action From Baseline in the MSC Score Over Period II | < 20% | 32.1 percentage of participants |
| Levocetirizine (LCTZ) | Intensity of Action From Baseline in the MSC Score Over Period II | >= 50% | 36.5 percentage of participants |
| Levocetirizine (LCTZ) | Intensity of Action From Baseline in the MSC Score Over Period II | < 70% | 83.3 percentage of participants |
| Levocetirizine (LCTZ) | Intensity of Action From Baseline in the MSC Score Over Period II | >= 20% | 67.9 percentage of participants |
| Levocetirizine (LCTZ) | Intensity of Action From Baseline in the MSC Score Over Period II | < 50% | 63.5 percentage of participants |
| Montelukast (MLKT) | Intensity of Action From Baseline in the MSC Score Over Period II | >= 20% | 46.4 percentage of participants |
| Montelukast (MLKT) | Intensity of Action From Baseline in the MSC Score Over Period II | < 50% | 87.4 percentage of participants |
| Montelukast (MLKT) | Intensity of Action From Baseline in the MSC Score Over Period II | >= 70% | 4.6 percentage of participants |
| Montelukast (MLKT) | Intensity of Action From Baseline in the MSC Score Over Period II | >= 50% | 12.6 percentage of participants |
| Montelukast (MLKT) | Intensity of Action From Baseline in the MSC Score Over Period II | < 20% | 53.6 percentage of participants |
| Montelukast (MLKT) | Intensity of Action From Baseline in the MSC Score Over Period II | < 70% | 95.4 percentage of participants |
Secondary
Intensity of Action From Baseline in the MSC Score Over Period III
The intensity of action was measured by the percentage of subjects with categorized percentage change from Baseline in the MSC score over Period III. Categories are defined as following: \< 20%, \>=20%, \< 50%, \>=50%, \< 70%, \>=70% change from Baseline.
Time frame: Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm]
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo (PBO) | Intensity of Action From Baseline in the MSC Score Over Period III | < 20% | 48.1 percentage of participants |
| Placebo (PBO) | Intensity of Action From Baseline in the MSC Score Over Period III | >= 20% | 51.9 percentage of participants |
| Placebo (PBO) | Intensity of Action From Baseline in the MSC Score Over Period III | < 50% | 84.6 percentage of participants |
| Placebo (PBO) | Intensity of Action From Baseline in the MSC Score Over Period III | >= 50% | 15.4 percentage of participants |
| Placebo (PBO) | Intensity of Action From Baseline in the MSC Score Over Period III | < 70% | 89.4 percentage of participants |
| Placebo (PBO) | Intensity of Action From Baseline in the MSC Score Over Period III | >= 70% | 10.6 percentage of participants |
| Levocetirizine (LCTZ) | Intensity of Action From Baseline in the MSC Score Over Period III | >= 70% | 30.1 percentage of participants |
| Levocetirizine (LCTZ) | Intensity of Action From Baseline in the MSC Score Over Period III | < 20% | 16.7 percentage of participants |
| Levocetirizine (LCTZ) | Intensity of Action From Baseline in the MSC Score Over Period III | >= 50% | 51.9 percentage of participants |
| Levocetirizine (LCTZ) | Intensity of Action From Baseline in the MSC Score Over Period III | < 70% | 69.9 percentage of participants |
| Levocetirizine (LCTZ) | Intensity of Action From Baseline in the MSC Score Over Period III | >= 20% | 83.3 percentage of participants |
| Levocetirizine (LCTZ) | Intensity of Action From Baseline in the MSC Score Over Period III | < 50% | 48.1 percentage of participants |
| Montelukast (MLKT) | Intensity of Action From Baseline in the MSC Score Over Period III | >= 20% | 68.2 percentage of participants |
| Montelukast (MLKT) | Intensity of Action From Baseline in the MSC Score Over Period III | < 50% | 63.6 percentage of participants |
| Montelukast (MLKT) | Intensity of Action From Baseline in the MSC Score Over Period III | >= 70% | 13.9 percentage of participants |
| Montelukast (MLKT) | Intensity of Action From Baseline in the MSC Score Over Period III | >= 50% | 36.4 percentage of participants |
| Montelukast (MLKT) | Intensity of Action From Baseline in the MSC Score Over Period III | < 20% | 31.8 percentage of participants |
| Montelukast (MLKT) | Intensity of Action From Baseline in the MSC Score Over Period III | < 70% | 86.1 percentage of participants |
Secondary
Onset of Action During Period I
The onset of action was defined as the first time point during Period I after initiation of the treatment when the reduction from Baseline in the MSC score for the active treatment group became statistically different from the placebo group and when this significant change was maintained for some period of time.
Time frame: During Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (PBO) | Onset of Action During Period I | NA hours |
| Levocetirizine (LCTZ) | Onset of Action During Period I | 1.5 hours |
| Montelukast (MLKT) | Onset of Action During Period I | 1.5 hours |
Secondary
Percentage of Subjects, at the End of Period III Who Are Willing to Take the Same Medication During the Next Pollen Season
At the end of Period III, each subject without reference to the Symptom Diary Card (SDC) answered to the question: Do you want to take the same treatment during the next pollen season? (yes or no).
Time frame: At the end of Period III (Day 2)
Population: Only subjects with valid data were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (PBO) | Percentage of Subjects, at the End of Period III Who Are Willing to Take the Same Medication During the Next Pollen Season | 23.1 percentage of participants |
| Levocetirizine (LCTZ) | Percentage of Subjects, at the End of Period III Who Are Willing to Take the Same Medication During the Next Pollen Season | 49.4 percentage of participants |
| Montelukast (MLKT) | Percentage of Subjects, at the End of Period III Who Are Willing to Take the Same Medication During the Next Pollen Season | 32.9 percentage of participants |
Secondary
Time to First Feeling of Improvement During Period I
During Period I, the subjects had to record the moment (hh:mm) of first feeling of improvement (compared to Baseline intensity of symptoms).
Time frame: During Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]
Population: Subjects with no first feeling of improvement were censored at 300 minutes.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo (PBO) | Time to First Feeling of Improvement During Period I | 101.02 minutes |
| Levocetirizine (LCTZ) | Time to First Feeling of Improvement During Period I | 70.02 minutes |
| Montelukast (MLKT) | Time to First Feeling of Improvement During Period I | 63.02 minutes |
Secondary
Variability of Action From Baseline in the MSC Score Over Period I
The variability of action was assessed by the percentage of distribution of the percentage change from Baseline in the MSC score. Categories are defined as following: \< 20%, 20%-35%, 35%-50%, 50%-65%, 65%-80%, \>=80%.
Time frame: Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo (PBO) | Variability of Action From Baseline in the MSC Score Over Period I | < 20% | 54.3 percentage of participants |
| Placebo (PBO) | Variability of Action From Baseline in the MSC Score Over Period I | 20%-35% | 15.2 percentage of participants |
| Placebo (PBO) | Variability of Action From Baseline in the MSC Score Over Period I | 35%-50% | 10.5 percentage of participants |
| Placebo (PBO) | Variability of Action From Baseline in the MSC Score Over Period I | 50%-65% | 12.4 percentage of participants |
| Placebo (PBO) | Variability of Action From Baseline in the MSC Score Over Period I | 65%-80% | 4.8 percentage of participants |
| Placebo (PBO) | Variability of Action From Baseline in the MSC Score Over Period I | >=80% | 2.9 percentage of participants |
| Levocetirizine (LCTZ) | Variability of Action From Baseline in the MSC Score Over Period I | >=80% | 3.2 percentage of participants |
| Levocetirizine (LCTZ) | Variability of Action From Baseline in the MSC Score Over Period I | < 20% | 21.0 percentage of participants |
| Levocetirizine (LCTZ) | Variability of Action From Baseline in the MSC Score Over Period I | 50%-65% | 12.7 percentage of participants |
| Levocetirizine (LCTZ) | Variability of Action From Baseline in the MSC Score Over Period I | 65%-80% | 15.3 percentage of participants |
| Levocetirizine (LCTZ) | Variability of Action From Baseline in the MSC Score Over Period I | 20%-35% | 22.9 percentage of participants |
| Levocetirizine (LCTZ) | Variability of Action From Baseline in the MSC Score Over Period I | 35%-50% | 24.8 percentage of participants |
| Montelukast (MLKT) | Variability of Action From Baseline in the MSC Score Over Period I | 20%-35% | 19.2 percentage of participants |
| Montelukast (MLKT) | Variability of Action From Baseline in the MSC Score Over Period I | 35%-50% | 16.0 percentage of participants |
| Montelukast (MLKT) | Variability of Action From Baseline in the MSC Score Over Period I | >=80% | 3.2 percentage of participants |
| Montelukast (MLKT) | Variability of Action From Baseline in the MSC Score Over Period I | 50%-65% | 20.5 percentage of participants |
| Montelukast (MLKT) | Variability of Action From Baseline in the MSC Score Over Period I | < 20% | 32.7 percentage of participants |
| Montelukast (MLKT) | Variability of Action From Baseline in the MSC Score Over Period I | 65%-80% | 8.3 percentage of participants |
Secondary
Variability of Action From Baseline in the MSC Score Over Period II
The variability of action was assessed by the percentage of distribution of the percentage change from Baseline in the MSC score. Categories are defined as following: \< 20%, 20%-35%, 35%-50%, 50%-65%, 65%-80%, \>=80%.
Time frame: Treatment Period II [Day 2, from 9:30 am to 11:00 am]
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo (PBO) | Variability of Action From Baseline in the MSC Score Over Period II | < 20% | 67.3 percentage of participants |
| Placebo (PBO) | Variability of Action From Baseline in the MSC Score Over Period II | 20%-35% | 17.3 percentage of participants |
| Placebo (PBO) | Variability of Action From Baseline in the MSC Score Over Period II | 35%-50% | 8.7 percentage of participants |
| Placebo (PBO) | Variability of Action From Baseline in the MSC Score Over Period II | 50%-65% | 3.8 percentage of participants |
| Placebo (PBO) | Variability of Action From Baseline in the MSC Score Over Period II | 65%-80% | 1.9 percentage of participants |
| Placebo (PBO) | Variability of Action From Baseline in the MSC Score Over Period II | >=80% | 1.0 percentage of participants |
| Levocetirizine (LCTZ) | Variability of Action From Baseline in the MSC Score Over Period II | >=80% | 9.0 percentage of participants |
| Levocetirizine (LCTZ) | Variability of Action From Baseline in the MSC Score Over Period II | < 20% | 32.1 percentage of participants |
| Levocetirizine (LCTZ) | Variability of Action From Baseline in the MSC Score Over Period II | 50%-65% | 17.3 percentage of participants |
| Levocetirizine (LCTZ) | Variability of Action From Baseline in the MSC Score Over Period II | 65%-80% | 10.3 percentage of participants |
| Levocetirizine (LCTZ) | Variability of Action From Baseline in the MSC Score Over Period II | 20%-35% | 19.2 percentage of participants |
| Levocetirizine (LCTZ) | Variability of Action From Baseline in the MSC Score Over Period II | 35%-50% | 12.2 percentage of participants |
| Montelukast (MLKT) | Variability of Action From Baseline in the MSC Score Over Period II | 20%-35% | 16.6 percentage of participants |
| Montelukast (MLKT) | Variability of Action From Baseline in the MSC Score Over Period II | 35%-50% | 17.2 percentage of participants |
| Montelukast (MLKT) | Variability of Action From Baseline in the MSC Score Over Period II | >=80% | 2.6 percentage of participants |
| Montelukast (MLKT) | Variability of Action From Baseline in the MSC Score Over Period II | 50%-65% | 6.6 percentage of participants |
| Montelukast (MLKT) | Variability of Action From Baseline in the MSC Score Over Period II | < 20% | 53.6 percentage of participants |
| Montelukast (MLKT) | Variability of Action From Baseline in the MSC Score Over Period II | 65%-80% | 3.3 percentage of participants |
Secondary
Variability of Action From Baseline in the MSC Score Over Period III
The variability of action was assessed by the percentage of distribution of the percentage change from Baseline in the MSC score. Categories are defined as following: \< 20%, 20%-35%, 35%-50%, 50%-65%, 65%-80%, \>=80%.
Time frame: Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm]
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo (PBO) | Variability of Action From Baseline in the MSC Score Over Period III | < 20% | 48.1 percentage of participants |
| Placebo (PBO) | Variability of Action From Baseline in the MSC Score Over Period III | 20%-35% | 21.2 percentage of participants |
| Placebo (PBO) | Variability of Action From Baseline in the MSC Score Over Period III | 35%-50% | 15.4 percentage of participants |
| Placebo (PBO) | Variability of Action From Baseline in the MSC Score Over Period III | 50%-65% | 3.8 percentage of participants |
| Placebo (PBO) | Variability of Action From Baseline in the MSC Score Over Period III | 65%-80% | 8.7 percentage of participants |
| Placebo (PBO) | Variability of Action From Baseline in the MSC Score Over Period III | >=80% | 2.9 percentage of participants |
| Levocetirizine (LCTZ) | Variability of Action From Baseline in the MSC Score Over Period III | >=80% | 19.9 percentage of participants |
| Levocetirizine (LCTZ) | Variability of Action From Baseline in the MSC Score Over Period III | < 20% | 16.7 percentage of participants |
| Levocetirizine (LCTZ) | Variability of Action From Baseline in the MSC Score Over Period III | 50%-65% | 14.1 percentage of participants |
| Levocetirizine (LCTZ) | Variability of Action From Baseline in the MSC Score Over Period III | 65%-80% | 17.9 percentage of participants |
| Levocetirizine (LCTZ) | Variability of Action From Baseline in the MSC Score Over Period III | 20%-35% | 17.9 percentage of participants |
| Levocetirizine (LCTZ) | Variability of Action From Baseline in the MSC Score Over Period III | 35%-50% | 13.5 percentage of participants |
| Montelukast (MLKT) | Variability of Action From Baseline in the MSC Score Over Period III | 20%-35% | 14.6 percentage of participants |
| Montelukast (MLKT) | Variability of Action From Baseline in the MSC Score Over Period III | 35%-50% | 17.2 percentage of participants |
| Montelukast (MLKT) | Variability of Action From Baseline in the MSC Score Over Period III | >=80% | 4.6 percentage of participants |
| Montelukast (MLKT) | Variability of Action From Baseline in the MSC Score Over Period III | 50%-65% | 17.2 percentage of participants |
| Montelukast (MLKT) | Variability of Action From Baseline in the MSC Score Over Period III | < 20% | 31.8 percentage of participants |
| Montelukast (MLKT) | Variability of Action From Baseline in the MSC Score Over Period III | 65%-80% | 14.6 percentage of participants |