Back to resultsA Study to Compare the Efficacy of Levocetirizine to Placebo in Reducing Symptoms of Seasonal Allergic Rhinitis (SAR) in Sensitive Subjects Exposed to Ragweed Pollen
Primary Purpose
Rhinitis, Allergic, Seasonal
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Placebo drops
Placebo tablets matching to levocetirizine
Placebo tablets matching to cetirizine
Levocetirizine drops
Levocetirizine tablets
Cetirizine drops
Cetirizine tablets
Sponsored by
About this trial
This is an interventional treatment trial for Rhinitis focused on measuring Levocetirizine, Xyzal, Rhinitis, Allergic, Seasonal, Ragweed
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Experimental
Arm Label
Placebo (PBO)
Levocetirizine (LCTZ) 2.5 mg
Levocetirizine (LCTZ) 5 mg
Cetirizine (CTZ) 5 mg
Cetirizine (CTZ) 10 mg
Arm 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Change From Baseline in the MSC Score Over the Total Treatment Period (Period I + Period II)
Six individual symptoms which are most dominant in the rhinitis symptom profile will be combined to form the MSC severity score:
Runny nose (right and left), itchy nose (right and left), sniffles, nose blows, sneezes, watery eyes.
Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The total MSC score ranges from 0 - 36. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.
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.
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.
Change From Baseline in the Total Symptom Complex (TSC) Score Over the Total Treatment Period (Period I + Period II)
The TSC score was calculated as the sum of the following 10 individual symptom scores:
runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip.
Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The TSC score ranges from 0 to 56. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.
Change From Baseline in the Individual Symptom Scores Over Period I
Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Watery Eyes Score, Sneezes Score, Nose Blows Score.
The subjects had to evaluate the severity of the symptoms using a scale from "None" to "Very severe" (ranging from 0 to 5).
For Sneezes Score and Nose Blows Score, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8.
Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.
Change From Baseline in the Individual Symptom Scores Over Period II
Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Watery Eyes Score, Sneezes Score, Nose Blows Score.
The subjects had to evaluate the severity of the symptoms using a scale from "None" to "Very severe" (ranging from 0 to 5).
For Sneezes Score and Nose Blows Score, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8.
Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.
Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II)
Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Watery Eyes Score, Sneezes Score, Nose Blows Score.
The subjects had to evaluate the severity of the symptoms using a scale from "None" to "Very severe" (ranging from 0 to 5).
For Sneezes Score and Nose Blows Score, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8.
Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00291642
Brief Title
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
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 Type
Interventional
2. Study Status
Record Verification Date
August 1, 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2006 (undefined)
Primary Completion Date
April 1, 2006 (Actual)
Study Completion Date
April 1, 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Pharma
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinitis, Allergic, Seasonal
Keywords
Levocetirizine, Xyzal, Rhinitis, Allergic, Seasonal, Ragweed
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
551 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo (PBO)
Arm Type
Placebo Comparator
Arm Description
A single dose of placebo was administered orally on Day 1.
Arm Title
Levocetirizine (LCTZ) 2.5 mg
Arm Type
Experimental
Arm Description
A single dose of 2.5 mg of LCTZ oral drops was administered orally on Day 1.
Arm Title
Levocetirizine (LCTZ) 5 mg
Arm Type
Experimental
Arm Description
A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1.
Arm Title
Cetirizine (CTZ) 5 mg
Arm Type
Experimental
Arm Description
A single dose of 5 mg of CTZ oral drops was administered orally on Day 1.
Arm Title
Cetirizine (CTZ) 10 mg
Arm Type
Experimental
Arm Description
A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1.
Intervention Type
Drug
Intervention Name(s)
Placebo drops
Intervention Description
Pharmaceutical form: Drops for oral administration
Route of administration: Oral use
Intervention Type
Drug
Intervention Name(s)
Placebo tablets matching to levocetirizine
Intervention Description
Pharmaceutical form: Tablets for oral administration
Route of administration: Oral use
Intervention Type
Drug
Intervention Name(s)
Placebo tablets matching to cetirizine
Intervention Description
Pharmaceutical form: Tablets for oral administration
Route of administration: Oral use
Intervention Type
Drug
Intervention Name(s)
Levocetirizine drops
Other Intervention Name(s)
Xyzal
Intervention Description
Pharmaceutical form: Drops for oral administration
Concentration: 5 mg/ml
Route of administration: Oral use
Intervention Type
Drug
Intervention Name(s)
Levocetirizine tablets
Other Intervention Name(s)
Xyzal
Intervention Description
Pharmaceutical form: Tablets for oral administration
Concentration: 5 mg
Route of administration: Oral use
Intervention Type
Drug
Intervention Name(s)
Cetirizine drops
Intervention Description
Pharmaceutical form: Drops for oral administration
Concentration: 10 mg/ml
Route of administration: Oral use
Intervention Type
Drug
Intervention Name(s)
Cetirizine tablets
Intervention Description
Pharmaceutical form: Tablets for oral administration
Concentration: 10 mg
Route of administration: Oral use
Primary Outcome Measure Information:
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)]
Secondary Outcome Measure Information:
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)]
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
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)]
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)]
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
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)]
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)]
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Cares
Organizational Affiliation
UCB (+1 844 599 2273)
Official's Role
Study Director
Facility Information:
City
Kingston
State/Province
Ontario
Country
Canada
12. IPD Sharing Statement
Links:
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
Learn more about this trial
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
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