Perennial Allergic RhinitisPhase 4NCT00894231
Levocetirizine Effect on Nasal Nitric Oxide and Nasal Eosinophils in Subjects With Perennial Allergic Rhinitis
A Phase 4 study testing levocetirizine (Xyzal) in people with Perennial Allergic Rhinitis, run by AAADRS Clinical Research Center at 1 site in United States.
Trial summary
The purpose of this study is to noninvasively measure the anti-inflammatory effect of levocetirizine after two weeks of treatment in allergic rhinitis subjects. Read more about this study
- Who is it for?
- Ages 12 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Perennial Allergic Rhinitis
- What is being tested?
- levocetirizine (Xyzal)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Aug 2009
- 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 12 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- ICF signed
- Diagnosis of PAR for 6-12 months greater
- 12 years and older
- Decreased nasal NO values at baseline
- Compliance and ability to perform maneuvers and responsibilities
Who cannot join
- Oral or systemic steroids for 60 days prior
- Inhaled, nasal, nebulized steroids w/i 4 weeks
- Hospitalization or life threatening asthma
- Use of nasal or oral antihistamines w/i 4 weeks
- Upper or lower airways infection
- Direct cigarette smoke exposure
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to noninvasively measure the anti-inflammatory effect of levocetirizine after two weeks of treatment in allergic rhinitis subjects.
- Conditions
- Perennial Allergic Rhinitis
- Being tested
- levocetirizine (Xyzal), placebo
- Medical subject headings
- Rhinitis, Allergic, Perennial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levocetirizine (Xyzal)Drug
Also called Xyzal
5mg po QD
placeboDrug
sugar tablet
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Sugar tablet Receives: Drug: placebo |
| Xyzal | Active comparator | Not described Receives: Drug: levocetirizine (Xyzal) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in objective measure of inflammation nasal NO after LC treatment.
Measured: two weeks
Secondary outcomes (1)
The change in nasal eosinophils, QOL and diary scores after LC treatment.
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2009 (estimated)
- Study startJan 2009
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perennial 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AAADRS Clinical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- UCB Pharma
- Investigators
- Miguel J Lanz, MD, Principal investigator, AAADRS Clinical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00894231
- Sponsor's protocol ID
- IIS071108
- Status last verified
- Sep 2009
- First submitted
- 17 Apr 2009
- Last updated
- 4 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Levocetirizine Effect on Nasal Nitric Oxide and Nasal Eosinophils in Subjects With Perennial Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT00894231
- Acronym / sponsor ID
- IIS071108
- Conditions
- Perennial Allergic Rhinitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- AAADRS Clinical Research CenterUniversity, hospital or other
- Collaborators
- UCB Pharma
- Study start
- Jan 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 6 May 2009 (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.
The purpose of this study is to noninvasively measure the anti-inflammatory effect of levocetirizine after two weeks of treatment in allergic rhinitis subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: placeboSugar tablet |
| Xyzal | Active comparator | Drug: levocetirizine (Xyzal) |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- ICF signed
- Diagnosis of PAR for 6-12 months greater
- 12 years and older
- Decreased nasal NO values at baseline
- Compliance and ability to perform maneuvers and responsibilities
Key exclusion criteria (6 listed)
- Oral or systemic steroids for 60 days prior
- Inhaled, nasal, nebulized steroids w/i 4 weeks
- Hospitalization or life threatening asthma
- Use of nasal or oral antihistamines w/i 4 weeks
- Upper or lower airways infection
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 (Xyzal)Also: Xyzal5mg po QD | Drug | Xyzal |
| placebosugar tablet | Drug | placebo |
Primary outcome
The change in objective measure of inflammation nasal NO after LC treatment.
Time frame: two weeks
1 secondary outcome
The change in nasal eosinophils, QOL and diary scores after LC treatment.
Time frame: two weeks
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 4 Sep 2009.
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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.
Miguel J Lanz, MD principal investigator
AAADRS Clinical Research Center
1 site 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 (Xyzal) in people with Perennial Allergic Rhinitis, run by AAADRS Clinical Research Center at 1 site 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 6 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 4 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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?
The change in objective measure of inflammation nasal NO after LC treatment. (time frame: two weeks). 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 4 Sep 2009.