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

This study has been completed.

First Received on August 24, 2007. Last Updated on September 9, 2009 History of Changes

Sponsor:	UCB, Inc.
Information provided by:	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT00521040

Purpose

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

Condition	Intervention
Rhinitis, Allergic, Seasonal	Drug: Levocetirizine dihydrochloride

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

MedlinePlus related topics: Asthma Hay Fever Itching

Drug Information available for: Levocetirizine Levocetirizine dihydrochloride

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:

T4SS (sum of the scores of the severity of sneezing, rhinorrhea, nasal pruritus and ocular pruritus) [ Time Frame: 12 weeks ]

Secondary Outcome Measures:

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 ]

Enrollment:	459
Study Start Date:	February 2004
Study Completion Date:	July 2004
Primary Completion Date:	July 2004 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 corticosteroiddependent asthma
atopic dermatitis or urticaria requiring an antihistamine treatment or the administration of oral or topical corticosteroids
contraindication for salbutamol use

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00521040

Sponsors and Collaborators

UCB, Inc.

Investigators

Study Director:

UCB Clinical Trial Call Center

UCB, Inc.

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00521040 History of Changes
Other Study ID Numbers:	A00306
Study First Received:	August 24, 2007
Last Updated:	September 9, 2009
Health Authority:	Belgium: Federal Agency for Medicines and Health Products

Keywords provided by UCB, Inc.:

Levocetirizine dihydrochloride
Xyzal tablets

Additional relevant MeSH terms:

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

Cetirizine
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
Anti-Allergic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2012