Seasonal Allergic RhinitisPhase 4NCT00621959
A Study Evaluating the Efficacy and Impact on Health-related Quality of Life of Levocetirizine in Adults With Seasonal Allergic Rhinitis
A Phase 4 study testing levocetirizine dihydrochloride in people with Seasonal Allergic Rhinitis, run by UCB Pharma at 26 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- levocetirizine dihydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 596 participants
- Where
- 26 sitesUnited States
- Study dates
- Mar 2008to Jun 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
United States26 sites
Study site
Albany, Georgia
Study site
Austin, Texas
Study site
Charleston, South Carolina
Study site
Dallas, Texas
Study site
El Paso, Texas
Study site
Fort Worth, Texas
Study site
Hot Springs, Arkansas
Study site
Huntington Beach, California
Study site
Katy, Texas
Study site
Knoxville, Tennessee
Study site
Lilburn, Georgia
Study site
Little Rock, Arkansas
Study site
Long Beach, California
Study site
Los Angeles, California
Study site
Metairie, Louisiana
Study site
Mission Viejo, California
Study site
New Braunfels, Texas
Study site
Owensboro, Kentucky
Study site
Plano, Texas
Study site
San Angelo, Texas
Study site
San Antonio, Texas
Study site
Savannah, Georgia
Study site
Scottsdale, Arizona
Study site
Tulsa, Oklahoma
Study site
Waco, Texas
Study site
Winston-Salem, North Carolina
About this study
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
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
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- levocetirizine dihydrochloride, placebo
- Keywords
- levocetirizine, Xyzal, Seasonal Allergic Rhinitis, total symptom score, quality of life
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levocetirizine dihydrochlorideDrug
Also called Xyzal
5mg daily (oral tablet) for 14 days
placeboDrug
0mg (matching oral tablet)for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Matched placebo tablets once daily Receives: Drug: placebo |
| LCTZ | Experimental | 5 mg levocetirizine dihydrochloride tablet Receives: Drug: levocetirizine dihydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Over the total treatment period (14 days)
Secondary outcomes (1)
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.
Measured: Baseline and endpoint, defined as the last available post-baseline observation during the two-week treatment period (in days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2008 (estimated)
- Study startMar 2008
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Seasonal Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 596 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call Center, Study director, +1 877 822 9493 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00621959
- Sponsor's protocol ID
- A00430
- Status last verified
- Jul 2020
- First submitted
- 11 Feb 2008
- Last updated
- 16 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 20377116Mansfield 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.
PubMed 20350147
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00621959
- Acronym / sponsor ID
- A00430
- Conditions
- Seasonal Allergic Rhinitis
- Keywords
- levocetirizine, Xyzal, Seasonal Allergic Rhinitis, total symptom score, quality of life
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 596 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 22 Feb 2008 (estimated)
- Results
- Posted 6 Aug 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: placeboMatched placebo tablets once daily |
| LCTZ | Experimental | Drug: levocetirizine dihydrochloride5 mg levocetirizine dihydrochloride tablet |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| levocetirizine dihydrochlorideAlso: Xyzal5mg daily (oral tablet) for 14 days | Drug | LCTZ |
| placebo0mg (matching oral tablet)for 14 days | Drug | Placebo |
Primary outcome
Mean 24-hour Reflective Total 5 Symptoms Score (T5SS)
Time frame: 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.
1 secondary outcome
Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score
Time frame: Baseline and endpoint, defined as the last available post-baseline observation during the two-week treatment period (in days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20377116Segall 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.
- Derived from this study: PubMed 20350147Mansfield 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.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
Related trials for Seasonal Allergic Rhinitis
RecruitingPhase 1
Safety, Tolerability And Pharmacodynamics of DM-101PX in Birch Pollen Allergy
Birch Pollen Allergy
Active, not recruitingPhase 3
A Clinical Study Evaluating the Efficacy and Safety of SHR-1819 Injection in Patients With Seasonal Allergic Rhinitis
Seasonal Allergic Rhinitis
Enrolling by invitationObservational study
Identification of Allergen-reactive Antibodies in the Blood of Pollen Allergic Patients
Pollen Allergy
RecruitingObservational study
Investigating Nasal and Ocular Immune Response to Conjunctival Allergen Exposure
Allergic Rhinoconjunctivitis
Recruiting
Evaluation of the Efficacy, Safety, and Tolerability of PL-14 Allergy Blocker Compared to Saline Spray in Patients With Seasonal Allergic Rhinitis
Seasonal Allergic Rhinitis (SAR), Allergic Rhinitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UCB Clinical Trial Call Center study director
+1 877 822 9493 (UCB)
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing levocetirizine dihydrochloride in people with Seasonal Allergic Rhinitis, run by UCB Pharma at 26 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean 24-hour Reflective Total 5 Symptoms Score (T5SS) (time frame: Over the total treatment period (14 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00621959, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2020.