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

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

This study has been completed.

Sponsors and Collaborators:	Schering-Plough Integrated Therapeutics Group
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00070707

Purpose

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.

Condition	Intervention	Phase
Rhinitis, Allergic, Seasonal Asthma	Drug: Nasonex	Phase IV

MedlinePlus related topics:

Asthma Hay Fever

ChemIDplus related topics:

Mometasone furoate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study

Further study details as provided by Schering-Plough:

Estimated Enrollment:	525
Study Start Date:	April 2003

Eligibility

Ages Eligible for Study:	15 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

No Contacts or Locations Provided

More Information

Study ID Numbers:	P03280
First Received:	October 7, 2003
Last Updated:	May 31, 2006
ClinicalTrials.gov Identifier:	NCT00070707
Health Authority:	United States: Food and Drug Administration

Keywords provided by Schering-Plough:

Seasonal Allergic Rhinitis

Concomitant Asthma

Study placed in the following topic categories:

Otorhinolaryngologic Diseases

SARS

Mometasone furoate

Asthma

Rhinitis

Lung Diseases, Obstructive

Hypersensitivity

Respiratory Tract Diseases

Respiratory Tract Infections

Rhinitis, Allergic, Seasonal

Lung Diseases

Hypersensitivity, Immediate

Respiratory Hypersensitivity

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Immune System Diseases

Bronchial Diseases

Therapeutic Uses

Anti-Allergic Agents

Pharmacologic Actions

Nose Diseases

ClinicalTrials.gov processed this record on August 21, 2008