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Completed

NCT Number: NCT00521131

Evaluation of Efficacy and Safety of Levocetirizine to Subjects With Perennial Allergic Rhinitis to House Dust Mites

Evaluation of Efficacy and Safety of Levocetirizine to Subjects With Perennial Allergic Rhinitis to House Dust Mites

Completed

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Key information

Conditions

Rhinitis Allergic Infections Nose Diseases Otorhinolaryngologic Diseases Perennial Respiratory Tract Diseases Respiratory Tract Infections

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • male or female ≥ 12 years
  • suffering from a perennial allergic rhinitis to house dust mites for at least 2 years
  • positive skin test or positive Radio-Allergo-Sorbent-Test for house dust mites
  • the mean of the T4SS evaluated in the evening over the last 24 hours of the selection period was ≥ 5

Exclusion criteria

  • seasonal allergic rhinitis likely to change significantly the symptoms of the subject
  • an ear, nose or throat (ENT) infection during the two weeks preceding initial visit
  • asthma requiring corticosteroid treatment
  • atopic dermatitis or urticaria requiring an antihistamine treatment or the administration of oral or topical corticosteroids
  • associated ENT disease

Treatment and study plan

levocetirizine dihydrochloride

Drug

Primary outcomes

  1. Number of comfortable days, as assessed by the subject

    Time frame: 30 days

Secondary outcomes

  1. Sum of 4 and 5 rhinitis symptoms and safety

    Time frame: Week 1 and over 30 days

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study title

Evaluation of Efficacy, Using the Number of Comfortable Days and the Safety of Levocetirizine Dihydrochloride, Administered Once Daily in the Evening for 30 Days, to Subjects Suffering From Perennial Allergic Rhinitis to House Dust Mites

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
Aug 27, 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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