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

Rhinitis Allergic, Persistent Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00598780
• Other study ID #: A00421
• Status: Completed
• Phase: N/A
• First received: January 11, 2008
• Last updated: May 25, 2012
• Start date: September 2007
• Est. completion date: September 2008

Study information

• Verified date: October 2008
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Slovakia: State Institute for Drug ControlCzech Republic: State Institute for Drug Control
• Study type: Observational

Clinical 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7870
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis Allergic, Persistent

Locations

Country	Name	City	State
United States	UCB Pharma	Smyrna	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To evaluate the global clinical improvement on levocetirizine compared to baseline at each follow up visit.		Six months	No
Secondary	To evaluate the treating physician's perception of patient satisfaction of levocetirizine tolerability at each follow up visit		six months	No
Secondary	To evaluate symptoms (nasal pruritus, rhinorrhea, nasal congestion, sneezing, ocular pruritus) at each follow up visit		six months	No
Secondary	To evaluate the impact of co-morbidities (asthma, urticaria and inflammation of upper airways) at each follow up visit		six months	No
Secondary	To evaluate the treating physician's perception of patient satisfaction of treatment regimen effectiveness at each follow up visit		six months	No
Secondary	To evaluate the treating physician's prescription practice in the treatment of Persistent Allergic Rhinitis		six months	No
Secondary	To evaluate concomitant medications prescribed with levocetirizine at each follow up visit		six months	No
Secondary	The evaluate reason for discontinuation at last follow up visit		six months	No
Secondary	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	No
Secondary	To evaluate the dose prescribed by the treating physician at each follow up visit		six months	No