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Completed

NCT Number: NCT00521040

Efficacy and Safety of Levocetirizine 8 Weeks Prior and After the Onset of the Grass Pollen Season in Subjects With SAR

Efficacy and Safety of Levocetirizine 8 Weeks Prior and After the Onset of the Grass Pollen Season in Subjects With 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

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • male or female subjects ≥ 12 years
  • 2 year history of seasonal allergic rhinitis
  • documented hypersensitivity to local seasonal allergens (grass pollen)
  • documented pollen-induced asthma
  • without acute ongoing exacerbation of asthma or allergic rhinitis
  • no continuous ongoing treatment for rhinitis or asthma

Exclusion criteria

  • non-allergic rhinitis and anatomic abnormalities disturbing the analysis of nasal capacity
  • symptomatic rhinitis or asthma due to tree pollens
  • currently treated by specific grass pollen immunotherapy
  • suffering from non-allergic asthma
  • chronic use of inhaled steroids and/or long acting β2 agonists; and/or corticosteroid dependent asthma
  • atopic dermatitis or urticaria requiring an antihistamine treatment or the administration of oral or topical corticosteroids
  • contraindication for salbutamol use

Treatment and study plan

levocetirizine dihydrochloride

Drug

Primary outcomes

  1. T4SS (sum of the scores of the severity of sneezing, rhinorrhea, nasal pruritus and ocular pruritus)

    Time frame: 12 weeks

Secondary outcomes

  1. Pollen-induced symptomatology of asthma; symptoms of rhinitis and asthma over the first 4 season weeks and during the entire observation period following the actual onset of the grass pollen season

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study title

Evaluation of the Efficacy and Safety of Levocetirizine During 8 Weeks Preceding and Following the Anticipated Onset of the Grass Pollen Season in Subjects Suffering From Seasonal Allergic Rhinitis Associated With Pollen-induced Asthma

Important dates

Study start
2004
Primary completion
2004
Study completion
2004
First posted
Aug 27, 2007
Registry last updated
Dec 12, 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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