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A Study in Subjects With Perennial Allergic Rhinitis
This study has been completed.
Sponsored by: Inspire Pharmaceuticals
Information provided by: Inspire Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00210015
  Purpose

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.


Condition Intervention Phase
Perennial Allergic Rhinitis
Drug: INS37217 Nasal Spray
Phase II

Drug Information available for: INS37217
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title: A Multi-Center, Randomized, Parallel-Group, Double-Blind, Efficacy and Safety Study of INS37217 Nasal Spray Versus Placebo in Subjects With Perennial Allergic Rhinitis

Further study details as provided by Inspire Pharmaceuticals:

Primary Outcome Measures:
  • total nasal symptom score

Secondary Outcome Measures:
  • 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
  • laboratory tests
  • ECG
  • vital signs
  • adverse events

Estimated Enrollment: 630
Study Start Date: December 2002
  Eligibility

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00210015

Sponsors and Collaborators
Inspire Pharmaceuticals
Investigators
Study Director: Amy Schaberg, B.S.N. unaffiliated
  More Information

Study ID Numbers: 07-105
Study First Received: September 13, 2005
Last Updated: September 13, 2005
ClinicalTrials.gov Identifier: NCT00210015  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Hypersensitivity
Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Rhinitis, Allergic, Perennial
Hypersensitivity, Immediate
Rhinitis
Respiratory Hypersensitivity

Additional relevant MeSH terms:
Immune System Diseases
Nose Diseases

ClinicalTrials.gov processed this record on January 16, 2009