Clinical trial NCT00291642: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rhinitis
Allergic
Seasonal
Keywords: Levocetirizine
Xyzal
Rhinitis
Allergic
Seasonal
Ragweed
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2006-02-14
Enrollment: 551
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change From Baseline in the Major Symptom Complex (MSC) Score Over Period I
timeFrame: Baseline, Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]
Secondary outcomes:
measure: Change From Baseline in the MSC Score Over Period II
timeFrame: Baseline, Treatment Period II [Day 2, (8:30 am to 12:00 pm)]
measure: Change From Baseline in the MSC Score Over the Total Treatment Period (Period I + Period II)
timeFrame: Baseline to Day 2
measure: Change From Baseline in the Total Symptom Complex (TSC) Score Over Period I
timeFrame: Baseline, Treatment Period I [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]
measure: Change From Baseline in the Total Symptom Complex (TSC) Score Over Period II
timeFrame: Baseline, Treatment Period II [Day 2, (8:30 am to 12:00 pm)]
measure: Change From Baseline in the Total Symptom Complex (TSC) Score Over the Total Treatment Period (Period I + Period II)
timeFrame: Baseline to Day 2
measure: Change From Baseline in the Individual Symptom Scores Over Period I
timeFrame: Baseline, Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]
measure: Change From Baseline in the Individual Symptom Scores Over Period II
timeFrame: Baseline, Treatment Period II [Day 2, (8:30 am to 12:00 pm)]
measure: Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II)
timeFrame: Baseline to Day 2
Other outcomes:
Locations:
city: Kingston
country: Canada
state: Ontario
Study officials:
affiliation: UCB (+1 844 599 2273)
name: UCB Cares
role: STUDY_DIRECTOR
References: