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CompletedNCT00598780Updated May 28, 2012

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

An observational study in Rhinitis Allergic, Persistent, sponsored by UCB Pharma. Completed at 1 site in United States. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2012-05-28.

Sponsored by UCB Pharma · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
7,870
Ages
2 Years and older
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Rhinitis Allergic, Persistent

Keywords

  • Levocetirizine
  • Xyzal
  • Rhinitis allergic persistent
  • Rhinitis nonseasonal
03

In context

Rhinitis

1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.

This study's enrollment of 7,870 is above the median of 141 across 172 observational studies indexed under Rhinitis.

Browse Rhinitis studies →

Lead sponsor

UCB Pharma is the lead sponsor of 238 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Age ≥ 2 years

Inclusion criteria

  • diagnosis of persistent allergic rhinitis
  • first prescription of levocetirizine for this diagnosis for this patient
  • age ≥ 2 years

Exclusion criteria

Exclusion Criteria:

  • indications other than those defined in inclusion criteria
  • history of allergic or anaphylactic reactions to levocetirizine or other derivatives and excipients included
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
7,870 participants (actual)

Groups and cohorts

  • 1

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

06

What researchers measure

Primary outcomes

  1. 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

  1. To evaluate the global clinical improvement on levocetirizine compared to baseline at each follow up visit.

    Time frame: Six months

  2. To evaluate the treating physician's perception of patient satisfaction of levocetirizine tolerability at each follow up visit

    Time frame: six months

  3. To evaluate symptoms (nasal pruritus, rhinorrhea, nasal congestion, sneezing, ocular pruritus) at each follow up visit

    Time frame: six months

  4. To evaluate the impact of co-morbidities (asthma, urticaria and inflammation of upper airways) at each follow up visit

    Time frame: six months

  5. To evaluate the treating physician's perception of patient satisfaction of treatment regimen effectiveness at each follow up visit

    Time frame: six months

  6. To evaluate the treating physician's prescription practice in the treatment of Persistent Allergic Rhinitis

    Time frame: six months

  7. To evaluate concomitant medications prescribed with levocetirizine at each follow up visit

    Time frame: six months

  8. The evaluate reason for discontinuation at last follow up visit

    Time frame: six months

  9. 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

    Time frame: six months

  10. To evaluate the dose prescribed by the treating physician at each follow up visit

    Time frame: six months

07

Study locations

1 site
  • UCB Pharma
    Smyrna, Georgia, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 28, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00598780
Lead sponsor
UCB Pharma
Responsible party
Sponsor
First posted
Jan 23, 2008
Start date
Sep 2007
Primary completion
Sep 2008
Completion
Sep 2008
Last update
May 28, 2012

Study contacts

UCB Clinical Trial Call Center
study director · +1 877 822 9493 (UCB)

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2008. You cannot join it, but the record below documents what was studied.

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