Can a Nasal Decongestant Test Predict Treatment Outcomes in Seasonal Allergic Rhinitis? - Full Text View

Sponsors and Collaborators:	University of Chicago Schering-Plough
Information provided by:	University of Chicago
ClinicalTrials.gov Identifier:	NCT00618332

Purpose

We hypothesize that those patients with purely seasonal allergic rhinitis will decongest better than those subjects with another cause contributing to their symptoms. These latter patients will not improve as well on an intranasal steroid as those who decongest well, potentially explaining the 60% response rate in prior studies.

Condition	Intervention
Seasonal Allergic Rhinitis	Drug: mometasone furoate nasal spray Drug: placebo

MedlinePlus related topics: Hay Fever

Drug Information available for: Mometasone furoate Phenylephrine Guaifenesin Naphazoline Naphazoline hydrochloride Oxymetazoline Oxymetazoline hydrochloride Phenylephrine hydrochloride Phenylpropanolamine Phenylpropanolamine hydrochloride Ephedrine Ephedrine Hydrochloride Pseudoephedrine hydrochloride Pseudoephedrine Sulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment
Official Title:	Does the Response to a Nasal Decongestant Test Predict the Outcome to Treatment of Seasonal Allergic Rhinitis With Nasonex?

Further study details as provided by University of Chicago:

Primary Outcome Measures:

correlation in Nasonex group of change in airflow (nasal peak inspiratory flow)on decongestant test and global assessment [ Time Frame: prior to and after 2 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

symptom diaries [ Time Frame: over 2 weeks of treatment ] [ Designated as safety issue: No ]
changes in RQLQ [ Time Frame: over 2 weeks of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	April 2008
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 2 weeks of treatment	Drug: mometasone furoate nasal spray 2 puffs in each nostril once a day for 2 weeks
2: Placebo Comparator 2 weeks of treatment	Drug: placebo 2 puffs in each nostril once a day for 2 weeks

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

Males and females between 18 and 60 years of age.
History of grass and/or ragweed allergic rhinitis.
Positive skin or RAST test to grass, trees and/or ragweed antigen.
Symptomatic at time of entry into study.

Exclusion Criteria

Women of childbearing potential not using the contraception method(s) (Birth control pills, depo Provera, double barrier) as well as women who are pregnant or breastfeeding.
Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (heart, lung, kidney, neurological, oncologic or liver disease).
Use of any other investigational agent in the last 30 days.
Absence of nasal symptoms.
Smoking.
URI at the time of screening.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00618332

Locations

United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637

Sponsors and Collaborators

University of Chicago

Schering-Plough

Investigators

Principal Investigator:

Ro M Naclerio, MD

University of Chicago

More Information

Responsible Party:	University of Chicago ( Robert M Naclerio, MD )
Study ID Numbers:	15624B
Study First Received:	February 6, 2008
Last Updated:	February 19, 2008
ClinicalTrials.gov Identifier:	NCT00618332
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Pseudoephedrine
Otorhinolaryngologic Diseases
Mometasone furoate
Rhinitis
Naphazoline
Oxymetazoline
Hypersensitivity
Respiratory Tract Diseases

Respiratory Tract Infections
Guaifenesin
Phenylephrine
Rhinitis, Allergic, Seasonal
Hypersensitivity, Immediate
Ephedrine
Phenylpropanolamine
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immune System Diseases
Therapeutic Uses

Anti-Allergic Agents
Pharmacologic Actions
Nose Diseases

ClinicalTrials.gov processed this record on January 16, 2009