Efficacy and Safety of Nasonex Vs. Placebo in Subjects With SAR and Concomitant Asthma (Study P03280)(COMPLETED)
Information source: Schering-Plough
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rhinitis, Allergic, Seasonal; Asthma
Intervention: Nasonex (Drug)
Phase: Phase 4
Sponsored by: Schering-Plough
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.
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study
Minimum age: 15 Years.
Maximum age: 75 Years.
- 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.
- Subjects with asthma who require chronic use of inhaled or systemic corticosteroids.
- Subjects who are morbidly obese (BMI>35)
Locations and Contacts
Starting date: April 2003
Last updated: May 31, 2006