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Completed

NCT Number: NCT00598780

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

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.

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Key information

Conditions

Rhinitis Allergic, Persistent Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Perennial

Age range

2 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UCB Pharma

Smyrna, Georgia, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study title

Long-term Evaluation of Safety and Treatment Satisfaction With Levocetirizine in Routine Clinical Practice in the Czech and Slovak Republics - Non-interventional Study

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jan 23, 2008
Registry last updated
May 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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