NCT00618332

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 20, 2008

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

January 10, 2014

Completed
Last Updated

February 14, 2014

Status Verified

January 1, 2014

Enrollment Period

3 months

First QC Date

February 6, 2008

Results QC Date

November 21, 2013

Last Update Submit

January 21, 2014

Conditions

Seasonal Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

  • Global Assessment

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

    at week 2

Secondary Outcomes (8)

  • Changes in RQLQ: Overall

    Baseline and 2 weeks

  • Changes in RQLQ: Activity

    Baseline and 2 weeks

  • Changes in RQLQ: Sleep

    Baseline and 2 weeks

  • Changes in RQLQ: Non-Nasal/Eye

    Baseline and 2 weeks

  • Changes in RQLQ: Practical

    Baseline and 2 weeks

  • +3 more secondary outcomes

Study Arms (2)

1

ACTIVE COMPARATOR

2 weeks of treatment

Drug: mometasone furoate nasal spray

2

PLACEBO COMPARATOR

2 weeks of treatment

Drug: placebo

Interventions

mometasone furoate nasal sprayDRUG

2 puffs in each nostril once a day for 2 weeks

Also known as: Nasonex
1
placeboDRUG

2 puffs in each nostril once a day for 2 weeks

Also known as: placebo comparator for Nasonex
2

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (1)

  • 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-Feb;32(1):55-63. doi: 10.2500/aap.2011.32.3414.

    PMID: 21262099DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Interventions

Mometasone Furoate

Condition Hierarchy (Ancestors)

Rhinitis, AllergicRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Results Point of Contact

Title
Dr. Robert Naclerio
Organization
University of Chicago
rnacleri@surgery.bsd.uchicago.edu
773-702-0080

Study Officials

  • Robert M Naclerio, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2008

First Posted

February 20, 2008

Study Start

April 1, 2008

Primary Completion

July 1, 2008

Study Completion

July 1, 2010

Last Updated

February 14, 2014

Results First Posted

January 10, 2014

Record last verified: 2014-01

Locations

US(1)