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OpenTrials
Completed

NCT Number: NCT00618332

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

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.

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Key information

Conditions

Seasonal Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Seasonal

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Chicago

Chicago, Illinois, 60637, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mometasone Furoate Nasal spray

Drug

2 puffs in each nostril once a day for 2 weeks

Other names: Nasonex

Placebo

Drug

2 puffs in each nostril once a day for 2 weeks

Other names: placebo comparator for Nasonex

Primary outcomes

  1. Global Assessment

    Time frame: at week 2

    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 outcomes

  1. Changes in RQLQ: Overall

    Time frame: Baseline and 2 weeks

    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.

  2. Changes in RQLQ: Activity

    Time frame: Baseline and 2 weeks

    The RQLQ activity range: 0-6. Higher scores indicate a worse quality of life.

  3. Changes in RQLQ: Sleep

    Time frame: Baseline and 2 weeks

    The RQLQ sleep range: 0-6. Higher scores indicate a worse quality of life.

  4. Changes in RQLQ: Non-Nasal/Eye

    Time frame: Baseline and 2 weeks

    The RQLQ non-nasal/eye range: 0-6. Higher scores indicate a worse quality of life.

  5. Changes in RQLQ: Practical

    Time frame: Baseline and 2 weeks

    The RQLQ practical range: 0-6. Higher scores indicate a worse quality of life.

  6. Changes in RQLQ: Nasal

    Time frame: Baseline and 2 weeks

    The RQLQ nasal range: 0-6. Higher scores indicate a worse quality of life.

  7. Changes in RQLQ: Emotional

    Time frame: Baseline and 2 weeks

    The RQLQ emotional range: 0-6. Higher scores indicate a worse quality of life.

  8. Changes in RQLQ: Eye

    Time frame: Baseline and 2 weeks

    The RQLQ eye range: 0-6. Higher scores indicate a worse quality of life.

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • Schering-Plough

Registry information

Official study title

Does the Response to a Nasal Decongestant Test Predict the Outcome to Treatment of Seasonal Allergic Rhinitis With Nasonex?

Important dates

Study start
2008
Primary completion
2008
Study completion
2010
First posted
Feb 20, 2008
Registry last updated
Feb 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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