A Study Evaluating the Efficacy and Impact on Health-related Quality of Life of Levocetirizine in Adults With Seasonal Allergic Rhinitis

Seasonal Allergic Rhinitis Clinical Trial

Official title:

A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Evaluating the Efficacy and Impact on Health-related Quality of Life of Levocetirizine 5 mg Once Daily Given for 2 Weeks in Subjects 18 yr of Age and Older With Seasonal Allergic Rhinitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00621959
• Other study ID #: A00430
• Status: Completed
• Phase: Phase 4
• Start date: March 2008
• Est. completion date: June 2008

Study information

• Verified date: July 2020
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study objective is to investigate the efficacy of levocetirizine in reducing symptoms associated with seasonal allergic rhinitis and in improving rhinitis-related Quality of Life

Recruitment information / eligibility

• Status: Completed
• Enrollment: 596
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Subjects with a history of SAR symptoms

• A positive skin prick test at least one grass allergen

• Moderate - severe SAR symptoms at baseline

• Women of childbearing potential must use a medically acceptable form of contraception

• 80% compliance on run in study medication and 80% compliance on completing the diary

Exclusion Criteria:

• The presence of any clinically significant comorbid disease which may interfere with the study assessments

• The presence of renal disease

• Pregnant or breastfeeding

• Subject is currently participating in another clinical trial

• Known hypersensitivity to piperazines or any of the excipients

• Intake of medications prohibited before the start of the trial

• Subjects who started or changed the dose of immunotherapy

• Rhinitis medicamentosa

• Subjects with a recent history (within the last 2 years) of drug or alcohol abuse.

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

Intervention

Drug:
• levocetirizine dihydrochloride
5mg daily (oral tablet) for 14 days
• placebo
0mg (matching oral tablet)for 14 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean 24-hour Reflective Total 5 Symptoms Score (T5SS)	Total 5 Symptoms Score (T5SS) is the sum of rhinorrhea, sneezing, nasal congestion, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). The total score varies from 0 to 15.	Over the total treatment period (14 days)
Secondary	Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score	The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Overall health-related quality of life is expressed as the mean of the seven dimension scores. The overall RQLQ score varies from 0 to 6.	Baseline and endpoint, defined as the last available post-baseline observation during the two-week treatment period (in days)

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