Clinical trial NCT00621959: A Study Evaluating the Efficacy and Impact on Health-related Quality of Life of Levocetirizine in Adults With Seasonal Allergic Rhinitis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Seasonal Allergic Rhinitis
Keywords: levocetirizine
Xyzal
Seasonal Allergic Rhinitis
total symptom score
quality of life
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2008-02-22
Enrollment: 596
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: 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.

Primary outcomes:
measure: Mean 24-hour Reflective Total 5 Symptoms Score (T5SS)
timeFrame: Over the total treatment period (14 days)
Secondary outcomes:
measure: Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score
timeFrame: Baseline and endpoint, defined as the last available post-baseline observation during the two-week treatment period (in days)
Other outcomes:
Locations:
city: Scottsdale
country: United States
state: Arizona
city: Hot Springs
country: United States
state: Arkansas
city: Little Rock
country: United States
state: Arkansas
city: Huntington Beach
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Mission Viejo
country: United States
state: California
city: Albany
country: United States
state: Georgia
city: Lilburn
country: United States
state: Georgia
city: Savannah
country: United States
state: Georgia
city: Owensboro
country: United States
state: Kentucky
city: Metairie
country: United States
state: Louisiana
city: Winston-Salem
country: United States
state: North Carolina
city: Tulsa
country: United States
state: Oklahoma
city: Charleston
country: United States
state: South Carolina
city: Knoxville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: El Paso
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Katy
country: United States
state: Texas
city: New Braunfels
country: United States
state: Texas
city: Plano
country: United States
state: Texas
city: San Angelo
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Waco
country: United States
state: Texas
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: Segall N, Gawchik S, Georges G, Haeusler JM. Efficacy and safety of levocetirizine in improving symptoms and health-related quality of life in US adults with seasonal allergic rhinitis: a randomized, placebo-controlled study. Ann Allergy Asthma Immunol. 2010 Mar;104(3):259-67. doi: 10.1016/j.anai.2009.12.003.
citation: Mansfield LE, Hampel F, Haeusler JM, Georges G. Study of levocetirizine in seasonal allergic rhinitis. Curr Med Res Opin. 2010 Jun;26(6):1269-75. doi: 10.1185/03007991003745233.