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:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator)
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
Study Completion Date:	July 2010
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

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

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:

Robert M Naclerio, MD

University of Chicago

More Information

No publications provided by University of Chicago

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Sharma S, Vasnani R, De Tineo M, Du G, Pinto JM, Baroody FM, Naclerio RM. Recruitment factors which affect the outcome of a seasonal allergic rhinitis trial. Allergy Asthma Proc. 2011 Jan;32(1):55-63.

Responsible Party:	Robert M Naclerio, MD, University of Chicago
ClinicalTrials.gov Identifier:	NCT00618332 History of Changes
Other Study ID Numbers:	15624B
Study First Received:	February 6, 2008
Last Updated:	July 28, 2010
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Rhinitis, Allergic, Seasonal
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections
Ephedrine
Oxymetazoline
Phenylephrine
Pseudoephedrine
Nasal Decongestants

Mometasone furoate
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Cardiovascular Agents
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Respiratory System Agents

ClinicalTrials.gov processed this record on February 09, 2012