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

Sponsor:	University of Chicago
Collaborator:	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

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?

Resource links provided by NLM:

MedlinePlus related topics: Cold and Cough Medicines Hay Fever

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

U.S. FDA Resources

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:	July 2009
Primary Completion Date:	July 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

No publications provided

Responsible Party:	University of Chicago ( Robert M Naclerio, MD )
Study ID Numbers:	15624B
Study First Received:	February 6, 2008
Last Updated:	May 6, 2009
ClinicalTrials.gov Identifier:	NCT00618332 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Otorhinolaryngologic Diseases
Immune System Diseases
Mometasone furoate
Rhinitis
Anti-Allergic Agents
Cardiovascular Agents
Pharmacologic Actions
Nose Diseases

Nasal Decongestants
Hypersensitivity
Respiratory Tract Diseases
Respiratory Tract Infections
Therapeutic Uses
Rhinitis, Allergic, Seasonal
Hypersensitivity, Immediate
Vasoconstrictor Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on February 08, 2010