A Study in Subjects With Perennial Allergic Rhinitis

Perennial Allergic Rhinitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00210015
• Other study ID #: 07-105
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: January 22, 2016
• Start date: December 2002
• Est. completion date: April 2003

Study information

• Verified date: January 2016
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 630
• Est. completion date: April 2003
• Est. primary completion date: April 2003
• Gender: Both
• Age group: N/A and older

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Perennial Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic, Perennial

Intervention

Drug:
• INS37217 Nasal Spray

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

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