Efficacy and Safety of Nasonex Vs. Placebo in Subjects With SAR and Concomitant Asthma (Study P03280)(COMPLETED) - Tabular View

Tracking Information
First Received Date ^ICMJE	October 7, 2003
Last Updated Date	May 31, 2006
Start Date ^ICMJE	April 2003
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00070707 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Efficacy and Safety of Nasonex Vs. Placebo in Subjects With SAR and Concomitant Asthma (Study P03280)(COMPLETED)
Official Title ^ICMJE
Brief Summary	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.
Detailed Description
Study Phase	Phase IV
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study
Condition ^ICMJE	Rhinitis, Allergic, Seasonal Asthma
Intervention ^ICMJE	Drug: Nasonex
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	525
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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)
Gender	Both
Ages	15 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT ID ^ICMJE	NCT00070707
Responsible Party
Study ID Numbers ^ICMJE	P03280
Study Sponsor ^ICMJE	Schering-Plough
Collaborators ^ICMJE	Integrated Therapeutics Group
Investigators ^ICMJE
Information Provided By	Schering-Plough
Verification Date	May 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP