Evaluation of Safety of Levocetirizine in Routine Clinical Practice-non- Interventional Study
This study has been completed.
Sponsor:
UCB, Inc.
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00598780
First received: January 11, 2008
Last updated: May 25, 2012
Last verified: October 2008
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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, Inc.:
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 More Information
No publications provided
| Responsible Party: | UCB, Inc. |
| 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, Inc.:
|
Levocetirizine Xyzal Rhinitis allergic persistent Rhinitis nonseasonal |
Additional relevant MeSH terms:
|
Rhinitis Nose Diseases Respiratory Tract Diseases Respiratory Tract Infections Otorhinolaryngologic 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 May 19, 2013