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

UCB Pharma7,870 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

7,870

Conditions

Rhinitis Allergic, Persistent

Eligibility

Sex: ALLMin age: 2 Years

Medical Language ↔ Plain English

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

Locations (1)

UCB Pharma

Smyrna, Georgia, United States

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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