Topical Allstate and Nasal Allergen Challenge

Allergic Rhinitis Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Trial of Topical Allstate in the Prevention of the Signs and Symptoms of the Acute Response to Nasal Allergen Challenge (CETALY0001)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01231724
• Other study ID #: 10-224-A
• Status: Withdrawn
• Phase: Phase 3
• First received: October 28, 2010
• Last updated: May 30, 2013
• Start date: November 2011
• Est. completion date: April 2012

Study information

• Verified date: May 2013
• Source: University of Chicago
• 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 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria

1. Males and females between 18 and 55 years of age.

2. History of grass and/or ragweed allergic rhinitis for at least 2 years.

3. Positive skin test to grass and/or ragweed antigen within prior 12 months.

4. Positive response to screening nasal challenge.

Exclusion Criteria

1. Respiratory disease other than allergic rhinitis, allergic conjunctivitis and mild asthma.

2. Use of nasal steroids, antihistamines in the last 2 weeks.

3. Upper respiratory infection, sinusitis less than 2 weeks before screening.

4. Structural nasal abnormalities or nasal polyps on examination, nasal ulcer, frequent nose bleeding, recent nasal surgery or nasal trauma (within 90 days).

5. Having poorly tolerated previous administration of allergens

6. Nasolacrimal drainage system malfunctions.

7. Participation in other investigational therapy in the last 30 days.

8. Any systemic disorder or medication interfering with the study.

9. FEV1<80% of predicted at screening for subjects with mild asthma.

10. Presence of allergic rhinitis symptoms in the screening period with TNSS >3 at baseline)

11. Undergoing allergen desensitization therapy.

12. Current smokers or recent ex-smokers.

13. Not willing to give informed consent

14. Inability to understand the nature and requirements of the study, or to comply with the study procedures.

15. 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinitis

Intervention

Device:
• Allstate Nasal Spray
Allstate Nasal Spray, two sprays (total 100 microliters) in each nostril.
• Placebo Nasal Spray
2 sprays in each nostril

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No