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

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ClinicalTrials.gov Identifier: NCT00621959
Recruitment Status : Completed
First Posted : February 22, 2008
Results First Posted : August 6, 2009
Last Update Posted : January 15, 2015
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Seasonal Allergic Rhinitis
Interventions Drug: levocetirizine dihydrochloride
Drug: placebo
Enrollment 596
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo LCTZ
Hide Arm/Group Description Matched placebo tablets once daily 5 mg levocetirizine dihydrochloride tablet once daily
Period Title: Overall Study
Started 295 [1] 301
Completed 288 292
Not Completed 7 9
Reason Not Completed
Adverse Event             4             2
Lack of Efficacy             1             1
Lost to Follow-up             0             2
Withdrawal by Subject             1             1
Other             1             3
[1]
In all 791 subjects have been screened and 596 have been randomized
Arm/Group Title Placebo LCTZ Total
Hide Arm/Group Description Matched placebo tablets once daily 5 mg levocetirizine dihydrochloride tablet once daily Total of all reporting groups
Overall Number of Baseline Participants 295 301 596
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 295 participants 301 participants 596 participants
37.36  (11.05) 37.02  (11.99) 37.18  (11.52)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 295 participants 301 participants 596 participants
Female
199
  67.5%
206
  68.4%
405
  68.0%
Male
96
  32.5%
95
  31.6%
191
  32.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 295 participants 301 participants 596 participants
295 301 596
1.Primary Outcome
Title Mean 24-hour Reflective Total 5 Symptoms Score (T5SS)
Hide Description 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.
Time Frame Over the total treatment period (14 days)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the Intent-To-Treat (ITT) population with available T5SS over the Total Treatment Period
Arm/Group Title Placebo LCTZ
Hide Arm/Group Description:
Matched placebo tablets once daily
5 mg levocetirizine dihydrochloride tablet once daily
Overall Number of Participants Analyzed 294 299
Mean (Standard Deviation)
Unit of Measure: points on a scale
8.96  (2.96) 8.77  (3.28)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, LCTZ
Comments The Null Hypothesis for the primary endpoint is expressed as follows: ‘The mean 24-hr reflective T5SS over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.546
Comments If the p-value of this estimated difference is lower than 5% the mean T5SS is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA including treatment and center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.14
Confidence Interval 95%
-0.59 to 0.31
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
2.Secondary Outcome
Title Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score
Hide Description 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.
Time Frame Baseline and endpoint, defined as the last available post-baseline observation during the two-week treatment period (in days)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the Intent-To-Treat (ITT) population with available overall RQLQ score at Endpoint visit and at Baseline
Arm/Group Title Placebo LCTZ
Hide Arm/Group Description:
Matched placebo tablets once daily
5 mg levocetirizine dihydrochloride tablet once daily
Overall Number of Participants Analyzed 294 299
Mean (Standard Deviation)
Unit of Measure: points on a scale
-1.07  (1.26) -1.12  (1.25)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, LCTZ
Comments The Null Hypothesis is expressed as follows: ‘The mean change from baseline in overall RQLQ score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.442
Comments If the p-value of this estimated difference is lower than 5% the mean change from baseline in overall RQLQ score is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the change from baseline in overall RQLQ score including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.08
Confidence Interval 95%
-0.27 to 0.12
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo LCTZ
Hide Arm/Group Description Matched placebo tablets once daily 5 mg levocetirizine dihydrochloride tablet once daily
All-Cause Mortality
Placebo LCTZ
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo LCTZ
Affected / at Risk (%) Affected / at Risk (%)
Total   2/295 (0.68%)   0/301 (0.00%) 
Gastrointestinal disorders     
Gastrooesophageal reflux disease * 1  1/295 (0.34%)  0/301 (0.00%) 
General disorders     
Non-cardiac chest pain * 1  1/295 (0.34%)  0/301 (0.00%) 
Psychiatric disorders     
Suicide attempt * 1  1/295 (0.34%)  0/301 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Placebo LCTZ
Affected / at Risk (%) Affected / at Risk (%)
Total   30/295 (10.17%)   29/301 (9.63%) 
General disorders     
Fatigue * 1  5/295 (1.69%)  9/301 (2.99%) 
Nervous system disorders     
Headache * 1  20/295 (6.78%)  10/301 (3.32%) 
Somnolence * 1  8/295 (2.71%)  12/301 (3.99%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
UCB has > 60 days but <= 180 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
Results Point of Contact
Name/Title: UCB Clinical Trial Call Center
Organization: UCB Pharma
Phone: +1 877 822 9493
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00621959     History of Changes
Other Study ID Numbers: A00430
First Submitted: February 11, 2008
First Posted: February 22, 2008
Results First Submitted: June 18, 2009
Results First Posted: August 6, 2009
Last Update Posted: January 15, 2015