A Study in Subjects With Perennial Allergic Rhinitis

A Multi-Center, Randomized, Parallel-Group, Double-Blind, Efficacy and Safety Study of INS37217 Nasal Spray Versus Placebo in Subjects With Perennial Allergic Rhinitis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00210015

Enrollment

630

Registered

2005-09-21

Start date

2002-12-31

Completion date

2003-04-30

Last updated

2016-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perennial Allergic Rhinitis

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.

Interventions

DRUGINS37217 Nasal Spray

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame
total nasal symptom score	—

Secondary

Measure	Time frame
global assessment of perennial allergic rhinitis symptoms	—
instantaneous assessment of symptoms	—
change from baseline in quality of life assessments	—
physical and anterior nasal exams	—
average total nasal symptom scores over various timepoints average individual symptom scores	—
ECG	—
vital signs	—
adverse events	—
laboratory tests	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026