Study of Bronchodilation Effects of Cetirizine

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary Objective :

To compare the acute bronchodilatory effects of cetirizine 10 mg tablet and nebulized levalbuterol using impulse oscillometry technique in asthmatic subjects aged 18 to 65 years old who have allergic rhinitis and show clinical evidence of bronchial hyper-reactivity.

Secondary Objective:

To assess the bronchodilatory effects of cetirizine 10 mg tablet versus placebo after two weeks of therapy using impulse oscillometry technique in subjects 18 to 65 years old who have allergic rhinitis and show clinical evidence of bronchial hyper-reactivity.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: California Allergy and Asthma Medical Group, Inc.
• Collaborator: McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
• Treatments: Cetirizine

Criteria

Inclusion Criteria:

• Age between 18 to 65 years of age

• Physician diagnosis of mild asthma based on the NIH guidelines

• Physician diagnosis of allergic rhinitis and confirmed by at least 3+ skin test response to at least one allergen

• Evidence of abnormal, reversible airway function on impulse oscillometry

• Ability to cooperate in measurement of impulse oscillometry

Exclusion Criteria:

• Treatment with inhaled or oral corticosteroids within one month of screening visit

• Change in dosage of intranasal corticosteroids, or oral anti- leukotrienes within one month of screening visit. Subjects on constant dose of intranasal corticosteroids or anti-leukotrienes for one month or more will be allowed in the study.

• Known history of reflux, lung disease, or congenital heart disease

• Known history of adverse reaction to cetirizine