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OpenTrials
Completed

NCT Number: NCT00544388

Efficacy of Levocetirizine and Cetirizine in Reducing Symptoms of Seasonal Allergic Rhinitis in Ragweed Sensitive Subjects

Controlled conditions of the EEU allow a reliable assessment of the efficacy and a determination of the action onset, action intensity and duration of effect of levocetirizine and cetirizine in order to establish the relative efficacy of these two drugs available for the treatment of SAR.

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Key information

Conditions

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

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male/Female, aged >= 16 years
  • seasonal allergic rhinitis that required pharmacologic therapy each year during the last 2 ragweed pollen seasons
  • documented seasonal allergy to ragweed pollen
  • total symptom score of at least 18 points.

Exclusion criteria

  • nasal anatomic deformities ? 50% obstruction
  • acute sinusitis within 30 days of Period 2
  • initiated or advanced an immunotherapy regimen
  • immunotherapy injections within 48 hours of pollen exposure
  • impaired hepatic function
  • history of malignancy
  • intolerance to histamines
  • asthma requiring medication more than occasionally

Treatment and study plan

levocetirizine dihydrochloride

Drug

Primary outcomes

  1. Mean change from baseline in major symptom complex score over Period 2 (21-29 hours after drug intake on Day 2).

Secondary outcomes

  1. Mean change from baseline in MSC score over each 2-hour interval.

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study title

Trial to Compare the Efficacy of Levocetirizine and Cetirizine in Reducing Symptoms of Seasonal Allergic Rhinitis in Ragweed Sensitive Subjects Exposed to Pollen Challenge in an Environmental Exposure Unit (EEU).

Important dates

Study start
2004
Primary completion
2004
Study completion
2004
First posted
Oct 16, 2007
Registry last updated
Dec 16, 2013

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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