Topical Allstate and Nasal Allergen Challenge

The University of Chicago

Status and phase: Withdrawn; Phase 3

Conditions: Allergic Rhinitis

Treatments: Device: Placebo Nasal Spray; Device: Allstate Nasal Spray

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01231724

10-224-A

Details and patient eligibility

About

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).

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Allstate Nasal Spray

Active Comparator group

Treatment:

Device: Allstate Nasal Spray

Placebo Nasal Spray

Placebo Comparator group

Treatment:

Device: Placebo Nasal Spray