Trial · NCT00653224
A Study Evaluating the Efficacy and Impact on Health-related Quality of Life of Levocetirizine in Adults With Seasonal Allergic Rhinitis
NCT00653224, Phase 4, Completed, UCB Pharma; results first posted 2009-11-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study Evaluating the Efficacy and Impact on Health-related Quality of Life of Levocetirizine in Adults With Seasonal Allergic Rhinitis. Trials, record NCT00653224. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00653224
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Evaluating the Efficacy and Impact on Health-related Quality of Life of Levocetirizine in Adults With Seasonal Allergic Rhinitis
- NCT number
- NCT00653224
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 580 participants, actual
- Lead sponsor
- UCB Pharma
- Conditions
- Seasonal Allergic Rhinitis
- Interventions
- levocetirizine dihydrochloride, placebo
- First posted
- 2008-04-04
- Last updated
- 2011-08-31
- Results first posted
- 2009-11-17
Source ClinicalTrials.gov
Registered outcomes90
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean 24-hour Reflective Total 5 Symptoms Score (T5SS) Over the Total Treatment Period (14 Days) | 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). Total score ranges from 0 to 15. |
| Secondary | Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Endpoint During the Two-week Treatment Period | Baseline and at endpoint of the 2 week treatment period | 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 and ranges from 0 to 6. Endpoint is defined as the last available postbaseline measurement during the two week treatment period. |
| Secondary | Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Week 1 | Baseline and week 1 | 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 and ranges from 0 to 6. |
| Secondary | Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Week 2 | Baseline and week 2 | 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 and ranges from 0 to 6. |
| Secondary | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Endpoint During the Two-week Treatment Period | Baseline and at endpoint of the 2 week treatment period | 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. Endpoint is defined as the last available postbaseline measurement during the two week treatment period. |
| Secondary | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Week 1 | Baseline and week 1 | 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. |
| Secondary | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Week 2 | Baseline and week 2 | 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. |
| Secondary | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Endpoint During the Two-week Treatment Period | Baseline and at endpoint of the 2 week treatment period | 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. Endpoint is defined as the last available postbaseline measurement during the two week treatment period. |
| Secondary | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Week 1 | Baseline and week 1 | 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. |
| Secondary | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Week 2 | Baseline and week 2 | 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. |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 registered outcomesOutcomes90
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean 24-hour Reflective Total 5 Symptoms Score (T5SS) Over the Total Treatment Period (14 Days) | Over the total treatment period (14 days) | Number of participants from the Intent to treat (ITT) population with available T5SS over the Total Treatment Period | points on a scale | MEAN |
| SECONDARY | Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Endpoint During the Two-week Treatment Period | Baseline and at endpoint of the 2 week treatment period | Number of participants from the ITT population with available overall RQLQ score at Endpoint visit and at Baseline | points on a scale | MEAN |
| SECONDARY | Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Week 1 | Baseline and week 1 | Number of participants from the ITT population with available RQLQ overall score at Visit 3 (Week 1) and at Baseline | points on a scale | MEAN |
| SECONDARY | Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Week 2 | Baseline and week 2 | Number of participants from the ITT population with available overall RQLQ score at Visit 4 (Week 2) and at Baseline | points on a scale | MEAN |
| SECONDARY | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Endpoint During the Two-week Treatment Period | Baseline and at endpoint of the 2 week treatment period | Number of participants from the ITT population with available RQLQ activities score at Endpoint visit and at Baseline | points on a scale | MEAN |
| SECONDARY | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Week 1 | Baseline and week 1 | Number of participants from the ITT population with available RQLQ activities score at Visit 3 (Week 1) and at Baseline | points on a scale | MEAN |
| SECONDARY | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Week 2 | Baseline and week 2 | Number of participants from the ITT population with available RQLQ activities score at Visit 4 (Week 2) and at Baseline | points on a scale | MEAN |
| SECONDARY | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Endpoint During the Two-week Treatment Period | Baseline and at endpoint of the 2 week treatment period | Number of participants from the ITT population with available RQLQ sleep score at Endpoint visit and at Baseline | points on a scale | MEAN |
| SECONDARY | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Week 1 | Baseline and week 1 | Number of participants from the ITT population with available RQLQ sleep score at Visit 3 (Week 1) and at Baseline | points on a scale | MEAN |
| SECONDARY | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Week 2 | Baseline and week 2 | Number of participants from the ITT population with available RQLQ sleep score at Visit 4 (Week 2) and at Baseline | points on a scale | MEAN |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 outcomesResults by group210
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean 24-hour Reflective Total 5 Symptoms Score (T5SS) Over the Total Treatment Period (14 Days) | Placebo | 8.68 | Standard Deviation 3.44 | points on a scale | |
| Mean 24-hour Reflective Total 5 Symptoms Score (T5SS) Over the Total Treatment Period (14 Days) | Levocetirizine | 7.87 | Standard Deviation 3.17 | points on a scale | |
| Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Endpoint During the Two-week Treatment Period | Placebo | -0.93 | Standard Deviation 1.12 | points on a scale | |
| Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Endpoint During the Two-week Treatment Period | Levocetirizine | -1.31 | Standard Deviation 1.15 | points on a scale | |
| Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Week 1 | Placebo | -0.60 | Standard Deviation 0.93 | points on a scale | |
| Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Week 1 | Levocetirizine | -0.94 | Standard Deviation 1.09 | points on a scale | |
| Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Week 2 | Placebo | -0.95 | Standard Deviation 1.12 | points on a scale | |
| Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Week 2 | Levocetirizine | -1.34 | Standard Deviation 1.15 | points on a scale | |
| Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Endpoint During the Two-week Treatment Period | Placebo | -1.28 | Standard Deviation 1.39 | points on a scale | |
| Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Endpoint During the Two-week Treatment Period | Levocetirizine | -1.55 | Standard Deviation 1.48 | points on a scale |
1 to 10 of 210Source ClinicalTrials.gov
See all 210 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 293 | |
| Overall Study | STARTED | Levocetirizine | 287 | |
| Overall Study | COMPLETED | Placebo | 286 | |
| Overall Study | COMPLETED | Levocetirizine | 280 | |
| Overall Study | NOT COMPLETED | Placebo | 7 | |
| Overall Study | NOT COMPLETED | Levocetirizine | 7 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | Placebo | 12 | 293 | |
| other | Headache | Nervous system disorders | Levocetirizine | 13 | 285 | |
| serious | Cellulitis | Infections and infestations | Placebo | 0 | 293 | |
| serious | Cellulitis | Infections and infestations | Levocetirizine | 1 | 285 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Levocetirizine | ||
| Total, other adverse events | Placebo | 12 | 293 |
| Total, other adverse events | Levocetirizine | 13 | 285 |
| Total, serious adverse events | Placebo | 0 | 293 |
| Total, serious adverse events | Levocetirizine | 1 | 285 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Levocetirizine vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00653224
GET https://conductscience.org/api/trials/v1/NCT00653224/registered?page=2