Compare the Efficacy of Levocetirizine and Montelukast to Placebo in Reducing Seasonal Allergic Rhinitis (SAR) Symptoms in Ragweed Sensitive Subjects
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)
1 other identifier
interventional
418
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jul 2006
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2006
CompletedFirst Posted
Study publicly available on registry
February 22, 2006
CompletedStudy Start
First participant enrolled
July 29, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2006
CompletedResults Posted
Study results publicly available
July 23, 2018
CompletedSeptember 11, 2018
August 1, 2018
2 months
February 20, 2006
October 10, 2017
August 13, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (25)
Change From Baseline in the MSC Score Over Period II
Baseline, Treatment Period II [Day 2, from 9:30 am to 11:00 am]
Change From Baseline in the MSC Score Over Period III
Baseline, Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm]
Change From Baseline in the MSC Score Over the Total Treatment Period (Period I + Period II + Period III)
Baseline to Day 2
Change From Baseline in the Total Symptom Complex (TSC) 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)]
Change From Baseline in the Total Symptom Complex (TSC) Score Over Period II
Baseline, Treatment Period II [Day 2, from 9:30 am to 11:00 am]
- +20 more secondary outcomes
Study Arms (3)
Placebo (PBO)
PLACEBO COMPARATORPlacebo was administered orally on Days 1 and 2.
Montelukast (MLKT)
EXPERIMENTAL10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
Levocetirizine (LCTZ)
EXPERIMENTAL5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.
Interventions
* Pharmaceutical form: Over-encapsulated tablet * Route of administration: Oral use
* Pharmaceutical form: Over-encapsulated tablet * Concentration: 10 mg * Route of administration: Oral use
* Pharmaceutical form: Over-encapsulated tablet * Concentration: 5 mg * Route of administration: Oral use
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Kingston, Ontario, Canada
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB
- Organization
- Cares
Study Officials
- STUDY DIRECTOR
UCB Cares
UCB (+1 844 599 2273)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2006
First Posted
February 22, 2006
Study Start
July 29, 2006
Primary Completion
October 1, 2006
Study Completion
October 1, 2006
Last Updated
September 11, 2018
Results First Posted
July 23, 2018
Record last verified: 2018-08