Efficacy and Safety of Nasonex vs. Placebo in Subjects with SAR and Concomitant Asthma

An association between seasonal allergic rhinitis (SAR) and allergic asthma has been established through epidemiologic, pathophysiologic, and therapeutic studies. This study will compare Nasonex Nasal Spray to Placebo in treating the nasal and asthma symptoms experienced by subjects with SAR and concomitant asthma.

Official Title

Conditions

– Rhinitis, Allergic, Seasonal- Asthma

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study

Further Details

Study Start

Eligibility & Criteria

Ages Eligible for Study: 15 Years – 75 Years, Genders Eligible for Study: Both Criteria Eligibility Criteria:Subject must have at least a two-year history of seasonal allergic rhinitis and of increase asthma symptoms associated with the allergy season under study. FEV 1 70% of predicted at both Screening and Baseline visits. Subject must demonstrate an increase in absolute FEV 1 less then 12%, with an absolute volume increase of at least 200 ml, after reversibility testing at Screening or within the past 12 months. Subjects must be skin test positive (skin prick test with a wheal diameter at least 3mm larger than the diluent control or intradermal testing with the wheal diameter at least 7 mm larger than diluent control) at screening, or within 12 months prior to the screening visit, to a seasonal allergen (which may include seasonal molds) prevalent during the study period. Exclusion Criteria:Subjects with asthma who require chronic use of inhaled or systemic corticosteroids. Subjects who are morbidly obese (BMI>35)

Total Enrolment

525

Contact Details

[1] Integrated Therapeutics Group