Phase 4
N=580
A Study Evaluating the Efficacy and Impact on Health-related Quality of Life of Levocetirizine in Adults With Seasonal Allergic Rhinitis
Seasonal Allergic Rhinitis
Bottom Line
View on ClinicalTrials.gov: NCT00653224 ↗Enrolled (actual)
580
Serious AEs
0.2%
Results posted
Nov 2009
Primary outcome: Primary: Mean 24-hour Reflective Total 5 Symptoms Score (T5SS) Over the Total Treatment Period (14 Days) — 8.68; 7.87 points on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- levocetirizine dihydrochloride (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- UCB Pharma
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean 24-hour Reflective Total 5 Symptoms Score (T5SS) Over the Total Treatment Period (14 Days) |
8.68; 7.87 | <0.001 sig |
| SECONDARY Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Endpoint During the Two-week Treatment Period |
-0.93; -1.31 | <0.001 sig |
| SECONDARY Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Week 1 |
-0.60; -0.94 | <0.001 sig |
| SECONDARY Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Week 2 |
-0.95; -1.34 | <0.001 sig |
| SECONDARY Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Endpoint During the Two-week Treatment Period |
-1.28; -1.55 | 0.042 sig |
| SECONDARY Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Week 1 |
-0.80; -1.13 | 0.014 sig |
| SECONDARY Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Week 2 |
-1.30; -1.58 | 0.036 sig |
| SECONDARY Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Endpoint During the Two-week Treatment Period |
-0.90; -1.19 | 0.010 sig |
| SECONDARY Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Week 1 |
-0.59; -0.84 | 0.026 sig |
| SECONDARY Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Week 2 |
-0.93; -1.20 | 0.018 sig |
| SECONDARY Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Non-nose/Eye Symptoms Score at Endpoint During the Two-week Treatment Period |
-0.71; -1.05 | 0.002 sig |
| SECONDARY Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Non-nose/Eye Symptoms Score at Week 1 |
-0.42; -0.70 | 0.006 sig |
| SECONDARY Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Non-nose/Eye Symptoms Score at Week 2 |
-0.73; -1.08 | 0.003 sig |
| SECONDARY Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Practical Problems Score at Endpoint During the Two-week Treatment Period |
-1.22; -1.62 | <0.001 sig |
| SECONDARY Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Practical Problems Score at Week 1 |
-0.76; -1.14 | <0.001 sig |
| SECONDARY Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Practical Problems Score at Week 2 |
-1.24; -1.66 | <0.001 sig |
| SECONDARY Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Nasal Symptoms Score at Endpoint During the Two-week Treatment Period |
-1.05; -1.45 | <0.001 sig |
| SECONDARY Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Nasal Symptoms Score at Week 1 |
-0.68; -1.05 | <0.001 sig |
| SECONDARY Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Nasal Symptoms Score at Week 2 |
-1.08; -1.49 | <0.001 sig |
| SECONDARY Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Eye Symptoms Score at Endpoint During the Two-week Treatment Period |
-0.88; -1.36 | <0.001 sig |
| SECONDARY Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Eye Symptoms Score at Week 1 |
-0.62; -1.04 | <0.001 sig |
| SECONDARY Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Eye Symptoms Score at Week 2 |
-0.89; -1.40 | <0.001 sig |
| SECONDARY Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Emotional Score at Endpoint During the Two-week Treatment Period |
-0.80; -1.21 | <0.001 sig |
| SECONDARY Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Emotional Score at Week 1 |
-0.51; -0.91 | <0.001 sig |
| SECONDARY Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Emotional Score at Week 2 |
-0.82; -1.24 | <0.001 sig |
| SECONDARY Total 5 Symptoms Score (T5SS) Over the First Week |
9.04; 8.24 | <0.001 sig |
| SECONDARY Total 5 Symptoms Score (T5SS) Over the Second Week |
8.20; 7.41 | <0.001 sig |
| SECONDARY Total 4 Symptoms Score (T4SS) Over the First Week |
7.07; 6.32 | <0.001 sig |
| SECONDARY Total 4 Symptoms Score (T4SS) Over the Second Week |
6.39; 5.74 | <0.001 sig |
| SECONDARY Total 4 Symptoms Score (T4SS) Over the Total Treatment Period (14 Days) |
6.78; 6.07 | <0.001 sig |
| SECONDARY Total Nasal Symptom Score (TNSS) Over the First Week |
9.11; 8.34 | <0.001 sig |
| SECONDARY Total Nasal Symptom Score (TNSS) Over the Second Week |
8.23; 7.45 | 0.005 sig |
| SECONDARY Total Nasal Symptom Score (TNSS) Over the Total Treatment Period (14 Days) |
8.73; 7.94 | <0.001 sig |
| SECONDARY Total Ocular Symptom Score (TOSS) Over the First Week |
4.29; 3.99 | <0.001 sig |
| SECONDARY Total Ocular Symptom Score (TOSS) Over the Second Week |
3.89; 3.60 | <0.001 sig |
| SECONDARY Total Ocular Symptom Score (TOSS) Over the Total Treatment Period (14 Days) |
4.13; 3.82 | <0.001 sig |
| SECONDARY Sneezing Score Over the First Week |
1.80; 1.57 | <0.001 sig |
| SECONDARY Sneezing Score Over the Second Week |
1.62; 1.41 | <0.001 sig |
| SECONDARY Sneezing Score Over the Total Treatment Period (14 Days) |
1.72; 1.50 | <0.001 sig |
| SECONDARY Rhinorrhea Score Over the First Week |
1.81; 1.59 | <0.001 sig |
| SECONDARY Rhinorrhea Score Over the Second Week |
1.63; 1.44 | 0.008 sig |
| SECONDARY Rhinorrhea Score Over the Total Treatment Period (14 Days) |
1.73; 1.53 | <0.001 sig |
| SECONDARY Nasal Congestion Score Over the First Week |
1.98; 1.92 | 0.384 |
| SECONDARY Nasal Congestion Score Over the Second Week |
1.81; 1.67 | 0.063 |
| SECONDARY Nasal Congestion Score Over the Total Treatment Period (14 Days) |
1.91; 1.80 | 0.124 |
| SECONDARY Nasal Pruritus Score Over the First Week |
1.80; 1.61 | 0.002 sig |
| SECONDARY Nasal Pruritus Score Over the Second Week |
1.63; 1.45 | 0.016 sig |
| SECONDARY Nasal Pruritus Score Over the Total Treatment Period (14 Days) |
1.73; 1.54 | 0.003 sig |
| SECONDARY Post-nasal Drip Score Over the First Week |
1.72; 1.65 | 0.088 |
| SECONDARY Post-nasal Drip Score Over the Second Week |
1.55; 1.48 | 0.117 |
| SECONDARY Post-nasal Drip Score Over the Total Treatment Period (14 Days) |
1.64; 1.57 | 0.065 |
| SECONDARY Ocular Pruritus Score Over the First Week |
1.65; 1.56 | <0.001 sig |
| SECONDARY Ocular Pruritus Score Over the Second Week |
1.52; 1.44 | 0.002 sig |
| SECONDARY Ocular Pruritus Score Over the Total Treatment Period (14 Days) |
1.59; 1.51 | <0.001 sig |
| SECONDARY Ocular Itching/Burning Score Over the First Week |
1.58; 1.53 | <0.001 sig |
| SECONDARY Ocular Itching/Burning Score Over the Second Week |
1.42; 1.39 | 0.006 sig |
| SECONDARY Ocular Itching/Burning Score Over the Total Treatment Period (14 Days) |
1.52; 1.47 | <0.001 sig |
| SECONDARY Ocular Tearing/Watering Score Over the First Week |
1.40; 1.26 | <0.001 sig |
| SECONDARY Ocular Tearing/Watering Score Over the Second Week |
1.27; 1.16 | 0.011 sig |
| SECONDARY Ocular Tearing/Watering Score Over the Total Treatment Period (14 Days) |
1.34; 1.22 | <0.001 sig |
| SECONDARY Ocular Redness Score Over the First Week |
1.31; 1.21 | 0.004 sig |
| SECONDARY Ocular Redness Score Over the Second Week |
1.20; 1.05 | <0.001 sig |
| SECONDARY Ocular Redness Score Over the Total Treatment Period (14 Days) |
1.27; 1.14 | <0.001 sig |
| SECONDARY Global Patient's Rating of Efficacy at Endpoint of the Two Week Treatment Period |
14; 6; 16; 11; 21; 8 | <0.001 sig |
| SECONDARY Global Physician's Rating of Efficacy at Endpoint During the Two Week Treatment Period |
5; 5; 13; 7; 18; 7 | <0.001 sig |
| SECONDARY Change From Baseline in the Dimension 1 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Work Time Missed Due to Allergy at Endpoint During the Two-week Treatment Period |
-1.01; -2.68 | 0.027 sig |
| SECONDARY Change From Baseline in the Dimension 1 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Work Time Missed Due to Allergy at Week 1 |
-1.33; -2.48 | 0.554 |
| SECONDARY Change From Baseline in the Dimension 1 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Work Time Missed Due to Allergy at Week 2 |
-0.93; -2.83 | 0.015 sig |
| SECONDARY Change From Baseline in the Dimension 2 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment While Working Due to Allergy at Endpoint During the Two-week Treatment Period |
-8.06; -13.98 | 0.016 sig |
| SECONDARY Change From Baseline in the Dimension 2 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment While Working Due to Allergy at Week 1 |
-5.64; -11.23 | 0.017 sig |
| SECONDARY Change From Baseline in the Dimension 2 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment While Working Due to Allergy at Week 2 |
-8.59; -14.34 | 0.027 sig |
| SECONDARY Change From Baseline in the Dimension 3 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Work Impairment Due to Allergy at Endpoint During the Two-week Treatment Period |
-8.61; -14.49 | 0.023 sig |
| SECONDARY Change From Baseline in the Dimension 3 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Work Impairment Due to Allergy at Week 1 |
-5.80; -11.77 | 0.015 sig |
| SECONDARY Change From Baseline in the Dimension 3 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Work Impairment Due to Allergy at Week 2 |
-9.14; -14.89 | 0.036 sig |
| SECONDARY Change From Baseline in the Dimension 4 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Class Time Missed Due to Allergy at Endpoint During the Two-week Treatment Period |
0.25; -3.64 | 0.102 |
| SECONDARY Change From Baseline in the Dimension 4 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Class Time Missed Due to Allergy at Week 1 |
-2.82; -3.27 | 0.493 |
| SECONDARY Change From Baseline in the Dimension 4 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Class Time Missed Due to Allergy at Week 2 |
-0.03; -3.64 | 0.117 |
| SECONDARY Change From Baseline in the Dimension 5 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment in the Classroom Due to Allergy at Endpoint During the Two-week Treatment Period |
-6.33; -7.73 | 0.409 |
| SECONDARY Change From Baseline in the Dimension 5 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment in the Classroom Due to Allergy at Week 1 |
-2.86; -6.00 | 0.432 |
| SECONDARY Change From Baseline in the Dimension 5 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment in the Classroom Due to Allergy at Week 2 |
-6.55; -7.73 | 0.450 |
| SECONDARY Change From Baseline in the Dimension 6 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Classroom Impairment Due to Allergy at Endpoint During the Two-week Treatment Period |
-5.22; -8.65 | 0.251 |
| SECONDARY Change From Baseline in the Dimension 6 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Classroom Impairment Due to Allergy at Week 1 |
-3.05; -7.18 | 0.258 |
| SECONDARY Change From Baseline in the Dimension 6 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Classroom Impairment Due to Allergy at Week 2 |
-5.52; -8.65 | 0.288 |
| SECONDARY Change From Baseline in the Dimension 7 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Activity Impairment Due to Allergy at Endpoint During the Two-week Treatment Period |
-11.71; -18.46 | <0.001 sig |
| SECONDARY Change From Baseline in the Dimension 7 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Activity Impairment Due to Allergy at Week 1 |
-6.85; -14.29 | <0.001 sig |
| SECONDARY Change From Baseline in the Dimension 7 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Activity Impairment Due to Allergy at Week 2 |
-12.05; -18.84 | 0.001 sig |
| SECONDARY Change From Baseline in Epworth Sleepiness Scale (ESS) Score at Endpoint During the Two-week Treatment Period |
-1.02; -1.79 | 0.027 sig |
| SECONDARY Change From Baseline in Epworth Sleepiness Scale (ESS) Score at Week 1 |
-0.67; -0.91 | 0.535 |
| SECONDARY Change From Baseline in Epworth Sleepiness Scale (ESS) Score at Week 2 |
-1.05; -1.78 | 0.042 sig |
| SECONDARY Sleepiness According to Epworth Sleepiness Scale (ESS) Score at Baseline and at Endpoint During the Two-week Treatment Period |
66; 63; 16; 13; 46; 57 | 0.171 |
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
Data sourced from ClinicalTrials.gov (NCT00653224). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.