Clinical trial NCT00598780: Evaluation of Safety of Levocetirizine in Routine Clinical Practice-non- Interventional Study
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rhinitis Allergic, Persistent
Keywords: Levocetirizine
Xyzal
Rhinitis allergic persistent
Rhinitis nonseasonal
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2008-01-23
Enrollment: 7870
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with newly diagnosed persistent allergic rhinitis, within the approved age limits.

Age ≥ 2 years

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

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with adverse events Number and type of serious adverse events Number of patients withdrawing levocetirizine treatment due to adverse events
timeFrame: Six Months
Secondary outcomes:
measure: To evaluate the global clinical improvement on levocetirizine compared to baseline at each follow up visit.
timeFrame: Six months
measure: To evaluate the treating physician's perception of patient satisfaction of levocetirizine tolerability at each follow up visit
timeFrame: six months
measure: To evaluate symptoms (nasal pruritus, rhinorrhea, nasal congestion, sneezing, ocular pruritus) at each follow up visit
timeFrame: six months
measure: To evaluate the impact of co-morbidities (asthma, urticaria and inflammation of upper airways) at each follow up visit
timeFrame: six months
measure: To evaluate the treating physician's perception of patient satisfaction of treatment regimen effectiveness at each follow up visit
timeFrame: six months
measure: To evaluate the treating physician's prescription practice in the treatment of Persistent Allergic Rhinitis
timeFrame: six months
measure: To evaluate concomitant medications prescribed with levocetirizine at each follow up visit
timeFrame: six months
measure: The evaluate reason for discontinuation at last follow up visit
timeFrame: six months
measure: 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
timeFrame: six months
measure: To evaluate the dose prescribed by the treating physician at each follow up visit
timeFrame: six months
Other outcomes:
Locations:
city: Smyrna
country: United States
facility: UCB Pharma
state: Georgia
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: