Seasonal Allergic RhinitisPhase 4NCT00160537
POPULAR (Preference Of Patient Using Levocetirizine in Allergic Rhinitis)
A Phase 4 study testing Levocetirizine in people with Seasonal Allergic Rhinitis, run by UCB Pharma.
Trial summary
Comparative study on clinical efficacy and safety of levocetirizine and desloratadine as measured by the subject's satisfaction/dissatisfaction after one week of treatment Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- Levocetirizine
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- May 2005to Jul 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Clinical history of SAR known and treated since 2 years.
- Positive skin prick test (wheal > 3 mm larger than the diluent control) or RAST (≥3.5 IU/ml) to grass pollen (less than 1 year).
- Minimum mean T5SS of 8 during the baseline period.
Who cannot join
- Have an associated asthma requiring a daily treatment other than β2 short acting agonist prn
- Have atopic dermatitis or urticaria requiring antihistamine treatment or the administration of oral or topical corticosteroids and any other disease requiring the administration of oral or topical corticosteroids
About this study
Official title: A Monocenter, Double-blind, Randomized Trial, With Two Parallel Groups Comparing the Clinical Efficacy of Levocetirizine 5 mg Capsules and Desloratadine 5 mg Capsules Taken Once a Day Over 3 Weeks of Treatment in Adult Subjects Suffering From Seasonal Allergic Rhinitis (SAR) Due to Grass Pollen
Comparative study on clinical efficacy and safety of levocetirizine and desloratadine as measured by the subject's satisfaction/dissatisfaction after one week of treatment
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- Levocetirizine
- Keywords
- Seasonal Allergic Rhinitis (SAR), Grass pollen, SAR Symptoms (sneezing, rhinorrhea, nasal / ocular pruritus, nasal congestion), POPULAR, Xyzal, Levocetirizine
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Sneezing, Rhinorrhea, Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevocetirizineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjects' satisfaction / dissatisfaction after the first week of treatment.
Secondary outcomes (1)
allergic rhinitis symptoms scores over the first week of treatment , subject's satisfaction / dissatisfaction of their choice of treatment after the first week of treatment, time to first feeling of (sufficient) symptom improvement during the first we
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startMay 2005
- Primary completionJul 2005
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- UCB Clinical Trial Call Center, Study director, UCB Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00160537
- Sponsor's protocol ID
- A00391
- Other IDs
- EudraCT 2004-002971-18, POPULAR
- Status last verified
- Sep 2009
- First submitted
- 8 Sep 2005
- Last updated
- 16 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Monocenter, Double-blind, Randomized Trial, With Two Parallel Groups Comparing the Clinical Efficacy of Levocetirizine 5 mg Capsules and Desloratadine 5 mg Capsules Taken Once a Day Over 3 Weeks of Treatment in Adult Subjects Suffering From Seasonal Allergic Rhinitis (SAR) Due to Grass Pollen
- ClinicalTrials.gov ID
- NCT00160537
- Acronym / sponsor ID
- A00391
- Conditions
- Seasonal Allergic Rhinitis
- Keywords
- Seasonal Allergic Rhinitis (SAR), Grass pollen, SAR Symptoms (sneezing, rhinorrhea, nasal / ocular pruritus, nasal congestion), POPULAR, Xyzal, Levocetirizine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Primary completion
- Jul 2005 (actual)
- Study completion
- Jul 2005 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparative study on clinical efficacy and safety of levocetirizine and desloratadine as measured by the subject's satisfaction/dissatisfaction after one week of treatment
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical history of SAR known and treated since 2 years.
- Positive skin prick test (wheal > 3 mm larger than the diluent control) or RAST (≥3.5 IU/ml) to grass pollen (less than 1 year).
- Minimum mean T5SS of 8 during the baseline period.
Key exclusion criteria (2 listed)
- Have an associated asthma requiring a daily treatment other than β2 short acting agonist prn
- Have atopic dermatitis or urticaria requiring antihistamine treatment or the administration of oral or topical corticosteroids and any other disease requiring the administration of oral or topical corticosteroids
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 | Drug | – |
Primary outcome
Subjects' satisfaction / dissatisfaction after the first week of treatment.
1 secondary outcome
allergic rhinitis symptoms scores over the first week of treatment , subject's satisfaction / dissatisfaction of their choice of treatment after the first week of treatment, time to first feeling of (sufficient) symptom improvement during the first we
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2013.
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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
UCB Pharma
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levocetirizine in people with Seasonal Allergic Rhinitis, run by UCB Pharma.
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 3 inclusion and 2 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 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Subjects' satisfaction / dissatisfaction after the first week of treatment.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2013.