Seasonal Allergic Rhinitis
Conditions
Keywords
levocetirizine, Xyzal, Seasonal Allergic Rhinitis, total symptom score, quality of life
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
Interventions
5mg daily (oral tablet) for 14 days
DRUGplacebo
0mg (matching oral tablet)for 14 days
Sponsors
UCB Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean 24-hour Reflective Total 5 Symptoms Score (T5SS) | Over the total treatment period (14 days) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score | Baseline and endpoint, defined as the last available post-baseline observation during the two-week treatment period (in days) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Matched placebo tablets once daily | 295 |
| LCTZ 5 mg levocetirizine dihydrochloride tablet once daily | 301 |
| Total | 596 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 2 |
| Overall Study | Lack of Efficacy | 1 | 1 |
| Overall Study | Lost to Follow-up | 0 | 2 |
| Overall Study | Other | 1 | 3 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Placebo | LCTZ | Total |
|---|---|---|---|
| Age, Continuous | 37.36 years STANDARD_DEVIATION 11.05 | 37.02 years STANDARD_DEVIATION 11.99 | 37.18 years STANDARD_DEVIATION 11.52 |
| Region of Enrollment United States | 295 participants | 301 participants | 596 participants |
| Sex: Female, Male Female | 199 Participants | 206 Participants | 405 Participants |
| Sex: Female, Male Male | 96 Participants | 95 Participants | 191 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 30 / 295 | 29 / 301 |
| serious Total, serious adverse events | 2 / 295 | 0 / 301 |
Outcome results
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.
Time frame: Over the total treatment period (14 days)
Population: Number of participants from the Intent-To-Treat (ITT) population with available T5SS over the Total Treatment Period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean 24-hour Reflective Total 5 Symptoms Score (T5SS) | 8.96 points on a scale | Standard Deviation 2.96 |
| LCTZ | Mean 24-hour Reflective Total 5 Symptoms Score (T5SS) | 8.77 points on a scale | Standard Deviation 3.28 |
Comparison: 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.'p-value: 0.54695% CI: [-0.59, 0.31]ANCOVA
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.
Time frame: Baseline and endpoint, defined as the last available post-baseline observation during the two-week treatment period (in days)
Population: Number of participants from the Intent-To-Treat (ITT) population with available overall RQLQ score at Endpoint visit and at Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score | -1.07 points on a scale | Standard Deviation 1.26 |
| LCTZ | Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score | -1.12 points on a scale | Standard Deviation 1.25 |
Comparison: 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.'p-value: 0.44295% CI: [-0.27, 0.12]ANCOVA