Rhinitis Allergic, PersistentNCT00598780
Evaluation of Safety of Levocetirizine in Routine Clinical Practice-non- Interventional Study
An observational study of Rhinitis Allergic, Persistent, run by UCB Pharma at 1 site in United States.
Trial summary
To evaluate over a period of 6 months the safety and the treatment satisfaction of newly prescribed levocetirizine in patients of age ≥ 2 years with persistent allergic rhinitis. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Rhinitis Allergic, Persistent
- How many people
- 7,870 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Sep 2008
- Phase
- Observational
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with newly diagnosed persistent allergic rhinitis, within the approved age limits. Age ≥ 2 years
Who may be able to join
- diagnosis of persistent allergic rhinitis
- first prescription of levocetirizine for this diagnosis for this patient
- age ≥ 2 years
Who cannot join
- indications other than those defined in inclusion criteria
- history of allergic or anaphylactic reactions to levocetirizine or other derivatives and excipients included
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Evaluation of Safety and Treatment Satisfaction With Levocetirizine in Routine Clinical Practice in the Czech and Slovak Republics - Non-interventional Study
To evaluate over a period of 6 months the safety and the treatment satisfaction of newly prescribed levocetirizine in patients of age ≥ 2 years with persistent allergic rhinitis.
Read the detailed description
This is a non-interventional, prospective, post-authorization, multi-centre cohort study in patients treated with levocetirizine.
The baseline data will be collected at the visit to the physician when levocetirizine is prescribed for the first time for the patient for Persistent Allergic Rhinitis. The data will then be collected during 2 visits occurring within the first 6 months of treatment, as usually scheduled in normal clinical practice in the Czech and Slovak Republics. This is after approximately 4 weeks and 6 months of treatment or earlier, if the treatment is stopped
- Conditions
- Rhinitis Allergic, Persistent
- Keywords
- Levocetirizine, Xyzal, Rhinitis allergic persistent, Rhinitis nonseasonal
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with newly diagnosed persistent allergic rhinitis, within the approved age limits. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with adverse events Number and type of serious adverse events Number of patients withdrawing levocetirizine treatment due to adverse events
Measured: Six Months
Secondary outcomes (10)
To evaluate the global clinical improvement on levocetirizine compared to baseline at each follow up visit.
Measured: Six months
To evaluate the treating physician's perception of patient satisfaction of levocetirizine tolerability at each follow up visit
Measured: six months
To evaluate symptoms (nasal pruritus, rhinorrhea, nasal congestion, sneezing, ocular pruritus) at each follow up visit
Measured: six months
To evaluate the impact of co-morbidities (asthma, urticaria and inflammation of upper airways) at each follow up visit
Measured: six months
To evaluate the treating physician's perception of patient satisfaction of treatment regimen effectiveness at each follow up visit
Measured: six months
To evaluate the treating physician's prescription practice in the treatment of Persistent Allergic Rhinitis
Measured: six months
To evaluate concomitant medications prescribed with levocetirizine at each follow up visit
Measured: six months
The evaluate reason for discontinuation at last follow up visit
Measured: six months
To evaluate the overall physician´s treatment satisfaction in comparison with previously used antihistamines in patient population previously treated by antihistamines at last follow up visit
Measured: six months
To evaluate the dose prescribed by the treating physician at each follow up visit
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2008 (estimated)
- Study startSep 2007
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinitis Allergic, PersistentStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7,870 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
- NCT00598780
- Sponsor's protocol ID
- A00421
- Status last verified
- Oct 2008
- First submitted
- 11 Jan 2008
- Last updated
- 28 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Evaluation of Safety and Treatment Satisfaction With Levocetirizine in Routine Clinical Practice in the Czech and Slovak Republics - Non-interventional Study
- ClinicalTrials.gov ID
- NCT00598780
- Acronym / sponsor ID
- A00421
- Conditions
- Rhinitis Allergic, Persistent
- Keywords
- Levocetirizine, Xyzal, Rhinitis allergic persistent, Rhinitis nonseasonal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,870 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 23 Jan 2008 (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.
To evaluate over a period of 6 months the safety and the treatment satisfaction of newly prescribed levocetirizine in patients of age ≥ 2 years with persistent allergic rhinitis.
Detailed description
This is a non-interventional, prospective, post-authorization, multi-centre cohort study in patients treated with levocetirizine.
The baseline data will be collected at the visit to the physician when levocetirizine is prescribed for the first time for the patient for Persistent Allergic Rhinitis. The data will then be collected during 2 visits occurring within the first 6 months of treatment, as usually scheduled in normal clinical practice in the Czech and Slovak Republics. This is after approximately 4 weeks and 6 months of treatment or earlier, if the treatment is stopped
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients with newly diagnosed persistent allergic rhinitis, within the approved age limits. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with newly diagnosed persistent allergic rhinitis, within the approved age limits. Age ≥ 2 years
Key inclusion criteria (3 listed)
- diagnosis of persistent allergic rhinitis
- first prescription of levocetirizine for this diagnosis for this patient
- age ≥ 2 years
Key exclusion criteria (2 listed)
- indications other than those defined in inclusion criteria
- history of allergic or anaphylactic reactions to levocetirizine or other derivatives and excipients included
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients with adverse events Number and type of serious adverse events Number of patients withdrawing levocetirizine treatment due to adverse events
Time frame: Six Months
10 secondary outcomes
To evaluate the global clinical improvement on levocetirizine compared to baseline at each follow up visit.
Time frame: Six months
To evaluate the treating physician's perception of patient satisfaction of levocetirizine tolerability at each follow up visit
Time frame: six months
To evaluate symptoms (nasal pruritus, rhinorrhea, nasal congestion, sneezing, ocular pruritus) at each follow up visit
Time frame: six months
To evaluate the impact of co-morbidities (asthma, urticaria and inflammation of upper airways) at each follow up visit
Time frame: six months
To evaluate the treating physician's perception of patient satisfaction of treatment regimen effectiveness at each follow up visit
Time frame: six months
To evaluate the treating physician's prescription practice in the treatment of Persistent Allergic Rhinitis
Time frame: six months
To evaluate concomitant medications prescribed with levocetirizine at each follow up visit
Time frame: six months
The evaluate reason for discontinuation at last follow up visit
Time frame: six months
To evaluate the overall physician´s treatment satisfaction in comparison with previously used antihistamines in patient population previously treated by antihistamines at last follow up visit
Time frame: six months
To evaluate the dose prescribed by the treating physician at each follow up visit
Time frame: six months
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 28 May 2012.
Related trials for Rhinitis Allergic, Persistent
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Study of the Effects and Mechanisms of Yeast Postbiotics on Persistent Allergic Rhinitis Symptoms
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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
+1 877 822 9493 (UCB)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rhinitis Allergic, Persistent, run by UCB Pharma 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 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 28 May 2012. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Number of patients with adverse events Number and type of serious adverse events Number of patients withdrawing levocetirizine treatment due to adverse events (time frame: Six Months). 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 28 May 2012.