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

Completed

• Conditions: Rhinitis Allergic, Persistent

• Registration Number: NCT00598780
• Lead Sponsor: UCB Pharma

Brief 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.

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 Timeline

• Study Start: 2007-09
• Study First Submitted: 2008-01-11
• Study First Submitted QC: 2008-01-22
• Study First Posted: 2008-01-23
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2008-10
• Last Update Submitted: 2012-05-25
• Last Update Posted: 2012-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7870

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
To evaluate the dose prescribed by the treating physician at each follow up visit	six months
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

Trial Locations

Locations (1)

UCB Pharma; 🇺🇸 Smyrna, Georgia, United States