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

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.

Study Overview

• Status: Completed
• Conditions: Rhinitis Allergic, Persistent

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 Type: Observational
• Enrollment (Actual): 7870

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Smyrna, Georgia, United States
      • UCB Pharma

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with newly diagnosed persistent allergic rhinitis, within the approved age limits.

Age ≥ 2 years

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
1; Patients with newly diagnosed persistent allergic rhinitis, within the approved age limits.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: UCB Pharma

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): September 1, 2008
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: January 11, 2008
• First Submitted That Met QC Criteria: January 22, 2008
• First Posted (Estimate): January 23, 2008

Study Record Updates

• Last Update Posted (Estimate): May 28, 2012
• Last Update Submitted That Met QC Criteria: May 25, 2012
• Last Verified: October 1, 2008

More Information

Terms related to this study

• Keywords: Xyzal; Levocetirizine; Rhinitis allergic persistent; Rhinitis nonseasonal
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic
• Other Study ID Numbers: A00421