NCT00210015

Brief Summary

The purpose of this study was to determine the efficacy and safety of the study drug compared to placebo for the treatment of subjects with perennial allergic rhinitis.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
630

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2002

Shorter than P25 for phase_2

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

Study Start

First participant enrolled

December 1, 2002

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
Last Updated

January 25, 2016

Status Verified

January 1, 2016

Enrollment Period

4 months

First QC Date

September 13, 2005

Last Update Submit

January 22, 2016

Conditions

Perennial Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

  • total nasal symptom score

Secondary Outcomes (9)

  • average total nasal symptom scores over various timepoints average individual symptom scores

  • global assessment of perennial allergic rhinitis symptoms

  • instantaneous assessment of symptoms

  • change from baseline in quality of life assessments

  • physical and anterior nasal exams

  • +4 more secondary outcomes

Interventions

INS37217 Nasal SprayDRUG

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Have a documented history of allergy to perennial allergens and demonstrated sensitivity by the results of prick or intradermal skin testing.
  • Have a self-reported history of at least mild, intermittent rhinorrhea and nasal blockage/stuffiness due to allergies.
  • Have not started or had a change in immunotherapy regimen.

You may not qualify if:

  • Have a physical obstruction in the nose.
  • Will likely have an acute increase in severity of allergic rhinitis due to seasonal aeroallergens during the trial.
  • Have acute or chronic sinusitis or had previous sinus surgery resulting in a significant change in the sinus or nasal anatomy.
  • Have rhinitis medicamentosa or any other acute or chronic condition that could confound evaluations of nasal symptoms.
  • Have asthma of sufficient severity to require use of excluded medications.
  • Have taken any medications excluded as listed in the protocol.
  • Have a clinically significant acute or chronic disease or clinically significant laboratory abnormality.
  • Are a current smoker, recent smoker or past smoker as defined in the protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial

Condition Hierarchy (Ancestors)

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

Study Officials

  • Amy Schaberg, B.S.N.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

December 1, 2002

Primary Completion

April 1, 2003

Study Completion

April 1, 2003

Last Updated

January 25, 2016

Record last verified: 2016-01