Topical Allstate and Nasal Allergen Challenge

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-04-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Allstate Nasal Spray

Group Type ACTIVE_COMPARATOR

Allstate Nasal Spray

Intervention Type DEVICE

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

Placebo Nasal Spray

Group Type PLACEBO_COMPARATOR

Placebo Nasal Spray

Intervention Type DEVICE

2 sprays in each nostril

Interventions

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Allstate Nasal Spray

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

Intervention Type DEVICE

Placebo Nasal Spray

2 sprays in each nostril

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No