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

This study has been completed.

First Received on October 7, 2003. Last Updated on May 31, 2006 History of Changes

Sponsor:	Schering-Plough
Collaborator:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Masking: Double-Blind Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Asthma Hay Fever

Drug Information available for: Mometasone furoate

U.S. FDA Resources

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

No publications provided

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

Keywords provided by Schering-Plough:

Seasonal Allergic Rhinitis
Concomitant Asthma

Additional relevant MeSH terms:

Asthma
Rhinitis, Allergic, Seasonal
Rhinitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity

Immune System Diseases
Nose Diseases
Otorhinolaryngologic Diseases
Respiratory Tract Infections
Mometasone furoate
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on February 09, 2012