Topical Allstate and Nasal Allergen Challenge

NCT01231724 | Withdrawn Phase 3

• 1 other identifier: 10-224-A
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see whether Allstate Nasal Spray when given in the nose is safe and can reduce the signs and symptoms of allergic rhinitis (hayfever).

Conditions

Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• Number of sneezes and total nasal symptom score (TNSS) (sum of nasal stuffiness, nasal discharge, and nasal itching) (scale 0-3 for each symptom; total score 0-9) are co-primary endpoints.

  10 minutes following each nasal challenge

Study Arms (2)

Allstate Nasal Spray

ACTIVE COMPARATOR

Device: Allstate Nasal Spray

Placebo Nasal Spray

PLACEBO COMPARATOR

Device: Placebo Nasal Spray

Interventions

Allstate Nasal Spray DEVICE

Allstate Nasal Spray, two sprays (total 100 microliters) in each nostril.

Allstate Nasal Spray

Placebo Nasal Spray DEVICE

2 sprays in each nostril

Placebo Nasal Spray

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Males and females between 18 and 55 years of age.
• History of grass and/or ragweed allergic rhinitis for at least 2 years.
• Positive skin test to grass and/or ragweed antigen within prior 12 months.
• Positive response to screening nasal challenge.

You may not qualify if:

• Respiratory disease other than allergic rhinitis, allergic conjunctivitis and mild asthma.
• Use of nasal steroids, antihistamines in the last 2 weeks.
• Upper respiratory infection, sinusitis less than 2 weeks before screening.
• Structural nasal abnormalities or nasal polyps on examination, nasal ulcer, frequent nose bleeding, recent nasal surgery or nasal trauma (within 90 days).
• Having poorly tolerated previous administration of allergens
• Nasolacrimal drainage system malfunctions.
• Participation in other investigational therapy in the last 30 days.
• Any systemic disorder or medication interfering with the study.
• FEV1\<80% of predicted at screening for subjects with mild asthma.
• Presence of allergic rhinitis symptoms in the screening period with TNSS \>3 at baseline)
• Undergoing allergen desensitization therapy.
• Current smokers or recent ex-smokers.
• Not willing to give informed consent
• Inability to understand the nature and requirements of the study, or to comply with the study procedures.
• Any social or medical condition that, in the opinion of the investigator, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.

Sponsors & Collaborators

• University of Chicago: lead
• McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.: collaborator

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Robert M Naclerio, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 28, 2010
• First Posted: November 1, 2010
• Study Start: November 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: April 1, 2012
• Last Updated: June 3, 2013

Record last verified: 2013-05

Locations

US (1)