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

Study Overview
=================
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.

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)

Conditions
-----------------
Rhinitis, Allergic, Seasonal

Intervention / Treatment
-----------------
* 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


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, Treatment Period II [Day 2, (8:30 am to 12:00 pm)] | 
| 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. | Baseline to Day 2 | 
| 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. | Baseline, Treatment Period I [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)] | 
| 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. | Baseline, Treatment Period II [Day 2, (8:30 am to 12:00 pm)] | 
| 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. | Baseline to Day 2 | 
| 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. | Baseline, Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)] | 
| 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. | Baseline, Treatment Period II [Day 2, (8:30 am to 12:00 pm)] | 
| 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. | Baseline to Day 2 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Levocetirizine, Xyzal, Rhinitis, Allergic, Seasonal, Ragweed