Clinical trial NCT00295022: Compare the Efficacy of Levocetirizine and Montelukast to Placebo in Reducing Seasonal Allergic Rhinitis (SAR) Symptoms in Ragweed Sensitive Subjects
Official title: Double-blind, Three Parallel Randomized Groups, Therapeutic Confirmatory Clinical Trial to Compare the Efficacy of Oral Levocetirizine 5 mg and Montelukast 10 mg 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: PHASE4
Conditions: Rhinitis, Allergic, Seasonal
Keywords: Levocetirizine
Xyzal
Rhinitis
Allergic
Seasonal
Ragweed
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2006-02-22
Enrollment: 418
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the clinical efficacy of levocetirizine 5 mg and montelukast 10 mg on symptoms of seasonal allergic rhinitis occurring in subjects exposed to ragweed pollen in an environmental exposure unit.


Eligibility criteria: Inclusion Criteria:

* Have had seasonal allergic rhinitis due to Ragweed for the last 2 consecutive years
* Subjects who obtain a minimum sum score, considering Seasonal Allergic Rhinitis (SAR) related symptoms (mean value), as defined by the 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, from 9:30 am to 11:00 am]
measure: Change From Baseline in the MSC Score Over Period III
timeFrame: Baseline, Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm]
measure: Change From Baseline in the MSC Score Over the Total Treatment Period (Period I + Period II + Period III)
timeFrame: Baseline to Day 2
measure: Change From Baseline in the Total Symptom Complex (TSC) 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)]
measure: Change From Baseline in the Total Symptom Complex (TSC) Score Over Period II
timeFrame: Baseline, Treatment Period II [Day 2, from 9:30 am to 11:00 am]
measure: Change From Baseline in the Total Symptom Complex (TSC) Score Over Period III
timeFrame: Baseline, Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm]
measure: Change From Baseline in the Total Symptom Complex (TSC) Score Over the Total Treatment Period (Period I + Period II + Period III)
timeFrame: Baseline to Day 2
measure: Change From Baseline in the TSC Score + Nasal Congestion 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)]
measure: Change From Baseline in the TSC Score + Nasal Congestion Score Over Period II
timeFrame: Baseline, Treatment Period II [Day 2, from 9:30 am to 11:00 am]
measure: Change From Baseline in the TSC Score + Nasal Congestion Score Over Period III
timeFrame: Baseline, Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm]
measure: Change From Baseline in the TSC Score + Nasal Congestion Score Over the Total Treatment Period (Period I + Period II + Period III)
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, from 9:30 am to 11:00 am]
measure: Change From Baseline in the Individual Symptom Scores Over Period III
timeFrame: Baseline, Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm]
measure: Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II + Period III)
timeFrame: Baseline to Day 2
measure: Time to First Feeling of Improvement During Period I
timeFrame: During Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]
measure: Onset of Action During Period I
timeFrame: During Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]
measure: Intensity of Action From Baseline in the MSC Score Over Period I
timeFrame: Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]
measure: Intensity of Action From Baseline in the MSC Score Over Period II
timeFrame: Treatment Period II [Day 2, from 9:30 am to 11:00 am]
measure: Intensity of Action From Baseline in the MSC Score Over Period III
timeFrame: Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm]
measure: Variability of Action From Baseline in the MSC Score Over Period I
timeFrame: Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]
measure: Variability of Action From Baseline in the MSC Score Over Period II
timeFrame: Treatment Period II [Day 2, from 9:30 am to 11:00 am]
measure: Variability of Action From Baseline in the MSC Score Over Period III
timeFrame: Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm]
measure: Global Satisfaction of the Subjects at the End of Period III
timeFrame: At the end of Period III (Day 2)
measure: Percentage of Subjects, at the End of Period III Who Are Willing to Take the Same Medication During the Next Pollen Season
timeFrame: At the end of Period III (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: