Topical Allstate and Nasal Allergen Challenge

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01231724
• Date of registration: 28/10/2010
• Primary sponsor: University of Chicago
• Public title: Topical Allstate and Nasal Allergen Challenge
• Scientific 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)
• Date of first enrolment: November 2011
• Target sample size: 20
• Recruitment status: Withdrawn
• URL: http://clinicaltrials.gov/show/NCT01231724
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Robert M Naclerio, MD
• Affiliation: University of Chicago

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Allergic Rhinitis

Intervention(s)

Device: Allstate Nasal Spray

Device: Placebo Nasal Spray

Primary Outcome(s)

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. [Time Frame: 10 minutes following each nasal challenge]

Secondary ID(s)

10-224-A

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.