Evaluation of Safety of Levocetirizine in Routine Clinical Practice-non- Interventional Study

Study Overview
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Brief Summary
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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
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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

Official Title
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Long-term Evaluation of Safety and Treatment Satisfaction With Levocetirizine in Routine Clinical Practice in the Czech and Slovak Republics - Non-interventional Study

Conditions
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Rhinitis Allergic, Persistent

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of persistent allergic rhinitis first prescription of levocetirizine for this diagnosis for this patient age ≥ 2 years Exclusion Criteria: indications other than those defined in inclusion criteria history of allergic or anaphylactic reactions to levocetirizine or other derivatives and excipients included

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Patients with newly diagnosed persistent allergic rhinitis, within the approved age limits. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse events Number and type of serious adverse events Number of patients withdrawing levocetirizine treatment due to adverse events |  | Six Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the global clinical improvement on levocetirizine compared to baseline at each follow up visit. |  | Six months | 
| To evaluate the treating physician's perception of patient satisfaction of levocetirizine tolerability at each follow up visit |  | six months | 
| To evaluate symptoms (nasal pruritus, rhinorrhea, nasal congestion, sneezing, ocular pruritus) at each follow up visit |  | six months | 
| To evaluate the impact of co-morbidities (asthma, urticaria and inflammation of upper airways) at each follow up visit |  | six months | 
| To evaluate the treating physician's perception of patient satisfaction of treatment regimen effectiveness at each follow up visit |  | six months | 
| To evaluate the treating physician's prescription practice in the treatment of Persistent Allergic Rhinitis |  | six months | 
| To evaluate concomitant medications prescribed with levocetirizine at each follow up visit |  | six months | 
| The evaluate reason for discontinuation at last follow up visit |  | 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 |  | six months | 
| To evaluate the dose prescribed by the treating physician at each follow up visit |  | six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Levocetirizine, Xyzal, Rhinitis allergic persistent, Rhinitis nonseasonal