A Study to Compare the Efficacy of Levocetirizine to Placebo in Reducing Symptoms of Seasonal Allergic Rhinitis (SAR) in Sensitive Subjects Exposed to Ragweed Pollen

• Sponsor: UCB Pharma (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00291642
• Collaborator: (none)
• Enrollment: 551
• Location: 1
• Arms: 5
• Duration (Months): 3
• Patients Per Site Per Month: 186.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rhinitis; Allergic; Seasonal	Drug: Placebo drops; Drug: Placebo tablets matching to levocetirizine; Drug: Placebo tablets matching to cetirizine; Drug: Levocetirizine drops; Drug: Levocetirizine tablets; Drug: Cetirizine drops; Drug: Cetirizine tablets	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 551 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Double Blind, Double-dummy, Five Parallel Groups, Randomized, Exploratory Clinical Trial to Compare the Efficacy of Single Dose of Levocetirizine 2.5 mg Oral Drops (5 mg/mL), Levocetirizine 5 mg Oral Tablets, Cetirizine 5 mg Oral Drops (10 mg/mL) and Cetirizine 10 mg Oral Tablets to Placebo in Reducing Symptoms of Seasonal Allergic Rhinitis (SAR) in Ragweed Sensitive Subjects Exposed to Ragweed Pollen in an Environmental Exposure Unit (EEU)
• Study Start Date: Jan 1, 2006
• Actual Primary Completion Date: Apr 1, 2006
• Actual Study Completion Date: Apr 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo (PBO) A single dose of placebo was administered orally on Day 1.	Drug: Placebo drops; Pharmaceutical form: Drops for oral administration Route of administration: Oral use; Drug: Placebo tablets matching to levocetirizine; Pharmaceutical form: Tablets for oral administration Route of administration: Oral use; Drug: Placebo tablets matching to cetirizine; Pharmaceutical form: Tablets for oral administration Route of administration: Oral use
Experimental: Levocetirizine (LCTZ) 2.5 mg A single dose of 2.5 mg of LCTZ oral drops was administered orally on Day 1.	Drug: Levocetirizine drops; Pharmaceutical form: Drops for oral administration Concentration: 5 mg/ml Route of administration: Oral use; Other Names: Xyzal
Experimental: Levocetirizine (LCTZ) 5 mg A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1.	Drug: Levocetirizine tablets; Pharmaceutical form: Tablets for oral administration Concentration: 5 mg Route of administration: Oral use; Other Names: Xyzal
Experimental: Cetirizine (CTZ) 5 mg A single dose of 5 mg of CTZ oral drops was administered orally on Day 1.	Drug: Cetirizine drops; Pharmaceutical form: Drops for oral administration Concentration: 10 mg/ml Route of administration: Oral use
Experimental: Cetirizine (CTZ) 10 mg A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1.	Drug: Cetirizine tablets; Pharmaceutical form: Tablets for oral administration Concentration: 10 mg Route of administration: Oral use

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Kingston	Ontario	Canada

Sponsors and Collaborators

• UCB Pharma

Investigators

• Study Director: UCB Cares, UCB ([phone])

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• FDA Safety Alerts and Recalls

Publications

None provided.

• Responsible Party: UCB Pharma
• ClinicalTrials.gov Identifier: NCT00291642
• Other Study ID Numbers: A00412
• First Posted: Feb 14, 2006
• Last Update Posted: Sep 11, 2018
• Last Verified: Aug 1, 2018

• Keywords provided by UCB Pharma: Levocetirizine; Xyzal; Rhinitis; Allergic; Seasonal; Ragweed
• Additional relevant MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Cetirizine; Levocetirizine

Study Results

Participant Flow

Recruitment Details	Participant Flow refers to the Randomized Set.

Arm/Group Title	Placebo (PBO)	Levocetirizine (LCTZ) 2.5 mg	Levocetirizine (LCTZ) 5 mg	Cetirizine (CTZ) 5 mg	Cetirizine (CTZ) 10 mg
Arm/Group Description	A single dose of placebo was administered orally on Day 1.	A single dose of 2.5 mg of LCTZ oral drops was administered orally on Day 1.	A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1.	A single dose of 5 mg of CTZ oral drops was administered orally on Day 1.	A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1.
Period Title: Overall Study
STARTED	78	116	119	119	119
COMPLETED	76	116	117	119	118
NOT COMPLETED	2	0	2	0	1

Baseline Characteristics

Arm/Group Title	Placebo (PBO)	Levocetirizine (LCTZ) 2.5 mg	Levocetirizine (LCTZ) 5 mg	Cetirizine (CTZ) 5 mg	Cetirizine (CTZ) 10 mg	Total Title
Arm/Group Description	A single dose of placebo was administered orally on Day 1.	A single dose of 2.5 mg of LCTZ oral drops was administered orally on Day 1.	A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1.	A single dose of 5 mg of CTZ oral drops was administered orally on Day 1.	A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1.
Overall Participants	78	116	119	119	119	551
Age (Count of Participants)
<=18 years	1 1.3%	2 1.7%	2 1.7%	6 5%	4 3.4%	15 2.7%
Between 18 and 65 years	76 97.4%	113 97.4%	114 95.8%	113 95%	114 95.8%	530 96.2%
>=65 years	1 1.3%	1 0.9%	3 2.5%	0 0%	1 0.8%	6 1.1%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	33.71 (12.46)	33.45 (11.28)	34.36 (12.84)	32.91 (11.30)	34.33 (11.65)	33.76 (11.86)
Sex: Female, Male (Count of Participants)
Female	42 53.8%	65 56%	68 57.1%	65 54.6%	72 60.5%	312 56.6%
Male	36 46.2%	51 44%	51 42.9%	54 45.4%	47 39.5%	239 43.4%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in the Major Symptom Complex (MSC) Score Over Period I
Description	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)]

Outcome Measure Data

Analysis Population Description

Only patients with valid MSC scores in Period I were included in the analysis.

Arm/Group Title	Placebo (PBO)	Levocetirizine (LCTZ) 2.5 mg	Levocetirizine (LCTZ) 5 mg	Cetirizine (CTZ) 5 mg	Cetirizine (CTZ) 10 mg
Arm/Group Description	A single dose of placebo was administered orally on Day 1.	A single dose of 2.5 mg of LCTZ oral drops was administered orally on Day 1.	A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1.	A single dose of 5 mg of CTZ oral drops was administered orally on Day 1.	A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1.
Measure Participants	78	116	119	119	119
Least Squares Mean (Standard Error) [units on a scale]	-3.80 (0.495)	-7.15 (0.406)	-7.05 (0.401)	-7.93 (0.401)	-7.54 (0.401)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo (PBO), Levocetirizine (LCTZ) 2.5 mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-3.35
	Confidence Interval	(2-Sided) 95%; -4.61 to -2.09
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.640
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo (PBO), Levocetirizine (LCTZ) 5 mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-3.25
	Confidence Interval	(2-Sided) 95%; -4.50 to -2.00
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.637
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo (PBO), Cetirizine (CTZ) 5 mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-4.13
	Confidence Interval	(2-Sided) 95%; -5.38 to -2.88
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.637
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo (PBO), Cetirizine (CTZ) 10 mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-3.74
	Confidence Interval	(2-Sided) 95%; -4.99 to -2.49
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.637
	Estimation Comments

2. Secondary Outcome

Title	Change From Baseline in the MSC Score Over Period II
Description	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)]

Outcome Measure Data

Analysis Population Description

Only patients with valid MSC scores in Period II were included in the analysis.

Arm/Group Title	Placebo (PBO)	Levocetirizine (LCTZ) 2.5 mg	Levocetirizine (LCTZ) 5 mg	Cetirizine (CTZ) 5 mg	Cetirizine (CTZ) 10 mg
Arm/Group Description	A single dose of placebo was administered orally on Day 1.	A single dose of 2.5 mg of LCTZ oral drops was administered orally on Day 1.	A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1.	A single dose of 5 mg of CTZ oral drops was administered orally on Day 1.	A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1.
Measure Participants	76	116	117	119	118
Least Squares Mean (Standard Error) [units on a scale]	-3.50 (0.604)	-6.35 (0.489)	-7.07 (0.487)	-6.78 (0.483)	-7.92 (0.485)

3. Secondary Outcome

Title	Change From Baseline in the MSC Score Over the Total Treatment Period (Period I + Period II)
Description	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

Outcome Measure Data

Analysis Population Description

Only patients with valid MSC scores in Period I and II were included in the analysis.

Arm/Group Title	Placebo (PBO)	Levocetirizine (LCTZ) 2.5 mg	Levocetirizine (LCTZ) 5 mg	Cetirizine (CTZ) 5 mg	Cetirizine (CTZ) 10 mg
Arm/Group Description	A single dose of placebo was administered orally on Day 1.	A single dose of 2.5 mg of LCTZ oral drops was administered orally on Day 1.	A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1.	A single dose of 5 mg of CTZ oral drops was administered orally on Day 1.	A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1.
Measure Participants	78	116	119	119	119
Least Squares Mean (Standard Error) [units on a scale]	-3.61 (0.473)	-6.80 (0.388)	-7.10 (0.383)	-7.43 (0.384)	-7.72 (0.383)

4. Secondary Outcome

Title	Change From Baseline in the Total Symptom Complex (TSC) Score Over Period I
Description	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)]

Outcome Measure Data

Analysis Population Description

Only patients with valid TSC scores in Period I were included in the analysis.

Arm/Group Title	Placebo (PBO)	Levocetirizine (LCTZ) 2.5 mg	Levocetirizine (LCTZ) 5 mg	Cetirizine (CTZ) 5 mg	Cetirizine (CTZ) 10 mg
Arm/Group Description	A single dose of placebo was administered orally on Day 1.	A single dose of 2.5 mg of LCTZ oral drops was administered orally on Day 1.	A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1.	A single dose of 5 mg of CTZ oral drops was administered orally on Day 1.	A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1.
Measure Participants	78	116	119	119	119
Least Squares Mean (Standard Error) [units on a scale]	-6.55 (0.757)	-11.33 (0.620)	-11.27 (0.613)	-12.71 (0.613)	-11.74 (0.613)

5. Secondary Outcome

Title	Change From Baseline in the Total Symptom Complex (TSC) Score Over Period II
Description	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)]

Outcome Measure Data

Analysis Population Description

Only patients with valid TSC scores in Period II were included in the analysis.

Arm/Group Title	Placebo (PBO)	Levocetirizine (LCTZ) 2.5 mg	Levocetirizine (LCTZ) 5 mg	Cetirizine (CTZ) 5 mg	Cetirizine (CTZ) 10 mg
Arm/Group Description	A single dose of placebo was administered orally on Day 1.	A single dose of 2.5 mg of LCTZ oral drops was administered orally on Day 1.	A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1.	A single dose of 5 mg of CTZ oral drops was administered orally on Day 1.	A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1.
Measure Participants	76	116	117	119	118
Least Squares Mean (Standard Error) [units on a scale]	-5.73 (0.917)	-10.25 (0.742)	-11.03 (0.739)	-10.73 (0.734)	-12.14 (0.736)

6. Secondary Outcome

Title	Change From Baseline in the Total Symptom Complex (TSC) Score Over the Total Treatment Period (Period I + Period II)
Description	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

Outcome Measure Data

Analysis Population Description

Only patients with valid TSC scores in Period I and II were included in the analysis.

Arm/Group Title	Placebo (PBO)	Levocetirizine (LCTZ) 2.5 mg	Levocetirizine (LCTZ) 5 mg	Cetirizine (CTZ) 5 mg	Cetirizine (CTZ) 10 mg
Arm/Group Description	A single dose of placebo was administered orally on Day 1.	A single dose of 2.5 mg of LCTZ oral drops was administered orally on Day 1.	A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1.	A single dose of 5 mg of CTZ oral drops was administered orally on Day 1.	A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1.
Measure Participants	78	116	119	119	119
Least Squares Mean (Standard Error) [units on a scale]	-6.10 (0.729)	-10.86 (0.598)	-11.22 (0.591)	-11.84 (0.591)	-11.92 (0.591)

7. Secondary Outcome

Title	Change From Baseline in the Individual Symptom Scores Over Period I
Description	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)]

Outcome Measure Data

Analysis Population Description

Only subjects with valid individual symptom scores in Period I were included in the analysis.

Arm/Group Title	Placebo (PBO)	Levocetirizine (LCTZ) 2.5 mg	Levocetirizine (LCTZ) 5 mg	Cetirizine (CTZ) 5 mg	Cetirizine (CTZ) 10 mg
Arm/Group Description	A single dose of placebo was administered orally on Day 1.	A single dose of 2.5 mg of LCTZ oral drops was administered orally on Day 1.	A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1.	A single dose of 5 mg of CTZ oral drops was administered orally on Day 1.	A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1.
Measure Participants	78	116	119	119	119
Runny Nose Score	-0.60 (0.095)	-1.01 (0.078)	-0.95 (0.077)	-1.17 (0.077)	-1.04 (0.077)
Itchy Nose Score	-0.66 (0.099)	-1.03 (0.082)	-1.09 (0.081)	-1.28 (0.081)	-1.10 (0.081)
Sniffles Score	-0.65 (0.100)	-1.15 (0.082)	-1.06 (0.081)	-1.24 (0.081)	-1.10 (0.081)
Nose Blow Score	-0.98 (0.129)	-1.87 (0.106)	-1.82 (0.105)	-1.92 (0.105)	-1.96 (0.105)
Sneezes Score	-0.37 (0.103)	-1.15 (0.084)	-1.07 (0.083)	-1.22 (0.083)	-1.23 (0.083)
Watery Eyes Score	-0.56 (0.090)	-0.94 (0.074)	-1.08 (0.073)	-1.13 (0.073)	-1.07 (0.073)

8. Secondary Outcome

Title	Change From Baseline in the Individual Symptom Scores Over Period II
Description	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)]

Outcome Measure Data

Analysis Population Description

Only subjects with valid individual symptom scores in Period II were included in the analysis.

Arm/Group Title	Placebo (PBO)	Levocetirizine (LCTZ) 2.5 mg	Levocetirizine (LCTZ) 5 mg	Cetirizine (CTZ) 5 mg	Cetirizine (CTZ) 10 mg
Arm/Group Description	A single dose of placebo was administered orally on Day 1.	A single dose of 2.5 mg of LCTZ oral drops was administered orally on Day 1.	A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1.	A single dose of 5 mg of CTZ oral drops was administered orally on Day 1.	A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1.
Measure Participants	76	116	117	119	118
Runny Nose Score	-0.62 (0.122)	-0.86 (0.098)	-0.94 (0.098)	-0.95 (0.097)	-1.10 (0.098)
Itchy Nose Score	-0.57 (0.120)	-1.00 (0.097)	-1.11 (0.097)	-1.13 (0.096)	-1.24 (0.096)
Sniffles Score	-0.58 (0.127)	-0.91 (0.103)	-0.96 (0.102)	-0.90 (0.101)	-1.21 (0.102)
Nose Blow Score	-1.00 (0.162)	-1.61 (0.131)	-1.84 (0.131)	-1.78 (0.130)	-2.02 (0.130)
Sneezes Score	-0.48 (0.112)	-1.18 (0.091)	-1.33 (0.090)	-1.19 (0.089)	-1.38 (0.090)
Watery Eyes Score	-0.30 (0.119)	-0.78 (0.097)	-0.91 (0.096)	-0.83 (0.096)	-0.93 (0.096)

9. Secondary Outcome

Title	Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II)
Description	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

Outcome Measure Data

Analysis Population Description

Only subjects with valid individual symptom scores in Period I and II were included in the analysis.

Arm/Group Title	Placebo (PBO)	Levocetirizine (LCTZ) 2.5 mg	Levocetirizine (LCTZ) 5 mg	Cetirizine (CTZ) 5 mg	Cetirizine (CTZ) 10 mg
Arm/Group Description	A single dose of placebo was administered orally on Day 1.	A single dose of 2.5 mg of LCTZ oral drops was administered orally on Day 1.	A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1.	A single dose of 5 mg of CTZ oral drops was administered orally on Day 1.	A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1.
Measure Participants	78	116	119	119	119
Runny Nose Score	-0.59 (0.093)	-0.94 (0.076)	-0.95 (0.075)	-1.07 (0.075)	-1.06 (0.075)
Itchy Nose Score	-0.61 (0.097)	-1.02 (0.080)	-1.10 (0.079)	-1.21 (0.079)	-1.16 (0.079)
Sniffles Score	-0.60 (0.098)	-1.05 (0.080)	-1.02 (0.079)	-1.09 (0.079)	-1.15 (0.079)
Nose Blow Score	-0.98 (0.124)	-1.75 (0.102)	-1.83 (0.100)	-1.86 (0.101)	-1.99 (0.100)
Sneezes Score	-0.41 (0.090)	-1.17 (0.074)	-1.19 (0.073)	-1.21 (0.073)	-1.31 (0.073)
Watery Eyes Score	-0.44 (0.089)	-0.87 (0.073)	-1.01 (0.072)	-1.00 (0.073)	-1.01 (0.072)

Adverse Events

Time Frame	Adverse events were collected from Day 1 until up to 9 days after the study drug intake.
Adverse Event Reporting Description	Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
Arm/Group Title	Placebo (PBO)		Levocetirizine (LCTZ) 2.5 mg		Levocetirizine (LCTZ) 5 mg		Cetirizine (CTZ) 5 mg		Cetirizine (CTZ) 10 mg
Arm/Group Description	A single dose of placebo was administered orally on Day 1.		A single dose of 2.5 mg of LCTZ oral drops was administered orally on Day 1.		A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1.		A single dose of 5 mg of CTZ oral drops was administered orally on Day 1.		A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1.
All Cause Mortality
	Placebo (PBO)		Levocetirizine (LCTZ) 2.5 mg		Levocetirizine (LCTZ) 5 mg		Cetirizine (CTZ) 5 mg		Cetirizine (CTZ) 10 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/78 (0%)		0/116 (0%)		0/119 (0%)		0/119 (0%)		0/119 (0%)
Serious Adverse Events
	Placebo (PBO)		Levocetirizine (LCTZ) 2.5 mg		Levocetirizine (LCTZ) 5 mg		Cetirizine (CTZ) 5 mg		Cetirizine (CTZ) 10 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/78 (0%)		0/116 (0%)		0/119 (0%)		0/119 (0%)		0/119 (0%)
Other (Not Including Serious) Adverse Events
	Placebo (PBO)		Levocetirizine (LCTZ) 2.5 mg		Levocetirizine (LCTZ) 5 mg		Cetirizine (CTZ) 5 mg		Cetirizine (CTZ) 10 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/78 (6.4%)		10/116 (8.6%)		9/119 (7.6%)		13/119 (10.9%)		7/119 (5.9%)
Cardiac disorders
Palpitations	0/78 (0%)		1/116 (0.9%)		0/119 (0%)		0/119 (0%)		0/119 (0%)
Eye disorders
Conjunctivitis	0/78 (0%)		0/116 (0%)		2/119 (1.7%)		0/119 (0%)		0/119 (0%)
Ocular hyperaemia	0/78 (0%)		0/116 (0%)		1/119 (0.8%)		0/119 (0%)		0/119 (0%)
Vision blurred	0/78 (0%)		1/116 (0.9%)		0/119 (0%)		0/119 (0%)		0/119 (0%)
Gastrointestinal disorders
Abdominal discomfort	0/78 (0%)		1/116 (0.9%)		0/119 (0%)		0/119 (0%)		0/119 (0%)
Defaecation urgency	0/78 (0%)		1/116 (0.9%)		0/119 (0%)		0/119 (0%)		0/119 (0%)
Diarrhoea	0/78 (0%)		0/116 (0%)		0/119 (0%)		1/119 (0.8%)		0/119 (0%)
Dry mouth	0/78 (0%)		1/116 (0.9%)		2/119 (1.7%)		3/119 (2.5%)		2/119 (1.7%)
Flatulence	0/78 (0%)		0/116 (0%)		1/119 (0.8%)		0/119 (0%)		0/119 (0%)
Nausea	0/78 (0%)		1/116 (0.9%)		0/119 (0%)		2/119 (1.7%)		0/119 (0%)
Vomiting	0/78 (0%)		1/116 (0.9%)		0/119 (0%)		0/119 (0%)		0/119 (0%)
General disorders
Fatigue	0/78 (0%)		0/116 (0%)		2/119 (1.7%)		0/119 (0%)		1/119 (0.8%)
Pyrexia	1/78 (1.3%)		0/116 (0%)		0/119 (0%)		0/119 (0%)		0/119 (0%)
Musculoskeletal and connective tissue disorders
Back pain	0/78 (0%)		0/116 (0%)		0/119 (0%)		0/119 (0%)		1/119 (0.8%)
Neck pain	1/78 (1.3%)		0/116 (0%)		0/119 (0%)		0/119 (0%)		0/119 (0%)
Nervous system disorders
Dizziness	0/78 (0%)		0/116 (0%)		0/119 (0%)		1/119 (0.8%)		0/119 (0%)
Headache	2/78 (2.6%)		2/116 (1.7%)		0/119 (0%)		1/119 (0.8%)		2/119 (1.7%)
Paraesthesia	0/78 (0%)		1/116 (0.9%)		0/119 (0%)		0/119 (0%)		0/119 (0%)
Somnolence	0/78 (0%)		1/116 (0.9%)		1/119 (0.8%)		1/119 (0.8%)		0/119 (0%)
Syncope vasovagal	0/78 (0%)		0/116 (0%)		0/119 (0%)		0/119 (0%)		1/119 (0.8%)
Psychiatric disorders
Nervousness	0/78 (0%)		0/116 (0%)		0/119 (0%)		0/119 (0%)		1/119 (0.8%)
Respiratory, thoracic and mediastinal disorders
Dry throat	0/78 (0%)		1/116 (0.9%)		0/119 (0%)		2/119 (1.7%)		0/119 (0%)
Epistaxis	0/78 (0%)		1/116 (0.9%)		1/119 (0.8%)		0/119 (0%)		0/119 (0%)
Nasal dryness	0/78 (0%)		0/116 (0%)		0/119 (0%)		1/119 (0.8%)		0/119 (0%)
Nasal mucosal disorder	0/78 (0%)		0/116 (0%)		1/119 (0.8%)		0/119 (0%)		0/119 (0%)
Pharyngolaryngeal pain	0/78 (0%)		0/116 (0%)		0/119 (0%)		2/119 (1.7%)		1/119 (0.8%)
Rhinorrhoea	0/78 (0%)		0/116 (0%)		1/119 (0.8%)		0/119 (0%)		0/119 (0%)
Throat tightness	1/78 (1.3%)		0/116 (0%)		0/119 (0%)		0/119 (0%)		0/119 (0%)
Skin and subcutaneous tissue disorders
Periorbital oedema	0/78 (0%)		0/116 (0%)		0/119 (0%)		1/119 (0.8%)		0/119 (0%)
Rash	0/78 (0%)		1/116 (0.9%)		0/119 (0%)		0/119 (0%)		0/119 (0%)
Rash maculo-papular	0/78 (0%)		1/116 (0.9%)		0/119 (0%)		0/119 (0%)		0/119 (0%)
Rash pruritic	0/78 (0%)		1/116 (0.9%)		0/119 (0%)		0/119 (0%)		0/119 (0%)
Swelling face	0/78 (0%)		1/116 (0.9%)		0/119 (0%)		0/119 (0%)		0/119 (0%)
Urticaria	0/78 (0%)		1/116 (0.9%)		0/119 (0%)		0/119 (0%)		0/119 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.