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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00598780
First received: January 11, 2008
Last updated: May 25, 2012
Last verified: October 2008
  Purpose

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.


Condition
Rhinitis Allergic, Persistent

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

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

Enrollment: 7870
Study Start Date: September 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients with newly diagnosed persistent allergic rhinitis, within the approved age limits.

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

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00598780

Locations
United States, Georgia
UCB Pharma
Smyrna, Georgia, United States
Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided

Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00598780     History of Changes
Other Study ID Numbers: A00421
Study First Received: January 11, 2008
Last Updated: May 25, 2012
Health Authority: Slovakia: State Institute for Drug Control
Czech Republic: State Institute for Drug Control

Keywords provided by UCB Pharma:
Levocetirizine
Xyzal
Rhinitis allergic persistent
Rhinitis nonseasonal

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Levocetirizine
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014