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
- Conditions
- RhinitisAllergicSeasonal
- Interventions
- Drug: Placebo dropsDrug: Placebo tablets matching to cetirizine
- Registration Number
- NCT00291642
- Lead Sponsor
- UCB Pharma
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 551
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo (PBO) Placebo drops A single dose of placebo was administered orally on Day 1. Placebo (PBO) Placebo tablets matching to levocetirizine A single dose of placebo was administered orally on Day 1. Placebo (PBO) Placebo tablets matching to cetirizine A single dose of placebo was administered orally on Day 1. Levocetirizine (LCTZ) 2.5 mg Levocetirizine drops A single dose of 2.5 mg of LCTZ oral drops was administered orally on Day 1. Levocetirizine (LCTZ) 5 mg Levocetirizine tablets A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1. Cetirizine (CTZ) 5 mg Cetirizine drops A single dose of 5 mg of CTZ oral drops was administered orally on Day 1. Cetirizine (CTZ) 10 mg Cetirizine tablets A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1.
- Primary Outcome Measures
Name Time Method 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
Name Time Method Change From Baseline in the MSC Score Over Period II Baseline, Treatment Period II [Day 2, (8:30 am to 12:00 pm)] Six individual symptoms which are most dominant in the rhinitis symptom profile will be combined to form the MSC severity score:
Runny nose (right and left), itchy nose (right and left), sniffles, nose blows, sneezes, watery eyes.
Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The total MSC score ranges from 0 - 36. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.Change From Baseline in the Individual Symptom Scores Over Period I Baseline, Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)] Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Watery Eyes Score, Sneezes Score, Nose Blows Score.
The subjects had to evaluate the severity of the symptoms using a scale from "None" to "Very severe" (ranging from 0 to 5).
For Sneezes Score and Nose Blows Score, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8.
Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.Change From Baseline in the Individual Symptom Scores Over Period II Baseline, Treatment Period II [Day 2, (8:30 am to 12:00 pm)] Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Watery Eyes Score, Sneezes Score, Nose Blows Score.
The subjects had to evaluate the severity of the symptoms using a scale from "None" to "Very severe" (ranging from 0 to 5).
For Sneezes Score and Nose Blows Score, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8.
Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.Change From Baseline in the MSC Score Over the Total Treatment Period (Period I + Period II) Baseline to Day 2 Six individual symptoms which are most dominant in the rhinitis symptom profile will be combined to form the MSC severity score:
Runny nose (right and left), itchy nose (right and left), sniffles, nose blows, sneezes, watery eyes.
Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The total MSC score ranges from 0 - 36. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.Change From Baseline in the Total Symptom Complex (TSC) Score Over Period I Baseline, Treatment Period I [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)] The TSC score was calculated as the sum of the following 10 individual symptom scores:
runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip.
Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The TSC score ranges from 0 to 56. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.Change From Baseline in the Total Symptom Complex (TSC) Score Over Period II Baseline, Treatment Period II [Day 2, (8:30 am to 12:00 pm)] The TSC score was calculated as the sum of the following 10 individual symptom scores:
runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip.
Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The TSC score ranges from 0 to 56. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.Change From Baseline in the 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.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.