Can a Nasal Decongestant Test Predict Treatment Outcomes in Seasonal Allergic Rhinitis?

This study has been completed.
Sponsor:
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00618332
First received: February 6, 2008
Last updated: January 21, 2014
Last verified: January 2014
  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:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Global Assessment [ Time Frame: at week 2 ] [ Designated as safety issue: No ]

    Global Assessment: 3=significantly improved, 2=moderately improved,

    1=mildly improved, 0=no change, -1=mildly worse, -2=moderately worse, and -3=significantly worse



Secondary Outcome Measures:
  • Changes in RQLQ: Overall [ Time Frame: Baseline and 2 weeks ] [ Designated as safety issue: No ]
    The RQLQ is a disease-specific measure of a patient's quality of life. It includes domains that measure nasal and eye symptoms as well as those of activity, sleep, non-nasal/eye symptoms, practical and emotional measures. A scale of 0-6 is used to record the patient responses, with lower scores reflecting a better quality of life. The average score of each domain is calculated as well as an overall domain score reflecting the average of all scores.

  • Changes in RQLQ: Activity [ Time Frame: Baseline and 2 weeks ] [ Designated as safety issue: No ]
    The RQLQ activity range: 0-6. Higher scores indicate a worse quality of life.

  • Changes in RQLQ: Sleep [ Time Frame: Baseline and 2 weeks ] [ Designated as safety issue: No ]
    The RQLQ sleep range: 0-6. Higher scores indicate a worse quality of life.

  • Changes in RQLQ: Non-Nasal/Eye [ Time Frame: Baseline and 2 weeks ] [ Designated as safety issue: No ]
    The RQLQ non-nasal/eye range: 0-6. Higher scores indicate a worse quality of life.

  • Changes in RQLQ: Practical [ Time Frame: Baseline and 2 weeks ] [ Designated as safety issue: No ]
    The RQLQ practical range: 0-6. Higher scores indicate a worse quality of life.

  • Changes in RQLQ: Nasal [ Time Frame: Baseline and 2 weeks ] [ Designated as safety issue: No ]
    The RQLQ nasal range: 0-6. Higher scores indicate a worse quality of life.

  • Changes in RQLQ: Emotional [ Time Frame: Baseline and 2 weeks ] [ Designated as safety issue: No ]
    The RQLQ emotional range: 0-6. Higher scores indicate a worse quality of life.

  • Changes in RQLQ: Eye [ Time Frame: Baseline and 2 weeks ] [ Designated as safety issue: No ]
    The RQLQ eye range: 0-6. Higher scores indicate a worse quality of life.


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

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

Exclusion Criteria

  1. 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.
  2. 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).
  3. Use of any other investigational agent in the last 30 days.
  4. Absence of nasal symptoms.
  5. Smoking.
  6. URI at the time of screening.
  Contacts and Locations
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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):
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00618332     History of Changes
Other Study ID Numbers: 15624B
Study First Received: February 6, 2008
Results First Received: November 21, 2013
Last Updated: January 21, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections
Ephedrine
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
Bronchodilator Agents
Anti-Asthmatic Agents

ClinicalTrials.gov processed this record on August 20, 2014