Effect of Nasaleze on Nasal Challenge With Allergen

Not Applicable

Terminated

• Conditions: Allergic Rhinitis
• Interventions: Drug: Nasaleze Spray; Other: Placebo spray; Biological: Allergen

• Registration Number: NCT01723397
• Lead Sponsor: University of Chicago

Brief Summary

The objectives of this protocol are:

1. to confirm the inhibitory effect of Nasaleze on the immediate response to nasal challenge with antigen, and

2. to show that inhibition of the immediate response to nasal challenge with antigen by Nasaleze inhibits subsequent inflammatory events.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-05
• Study First Submitted QC: 2012-11-06
• Study First Posted: 2012-11-07
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Results First Submitted: 2016-09-06
• Results First Submitted QC: 2016-09-06
• Results First Posted: 2016-10-27
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-07
• Last Update Posted: 2017-01-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Not provided

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Exclusion Criteria

1. Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.
2. Pregnant or lactating women.
3. Upper respiratory infection within 14 days of study start.
4. FEV1<80% of predicted at screening for subjects with history of mild asthma.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Nasaleze spray	Allergen	Nasaleze spray 1 puff via "spray device" in each nostril 3 times daily for 1 week followed by allergen challenge
Nasaleze spray	Nasaleze Spray	Nasaleze spray 1 puff via "spray device" in each nostril 3 times daily for 1 week followed by allergen challenge
Placebo spray	Placebo spray	Placebo spray 1 puff via "spray device" in each nostril 3 times daily for 1 week followed by allergen challenge
Placebo spray	Allergen	Placebo spray 1 puff via "spray device" in each nostril 3 times daily for 1 week followed by allergen challenge

Primary Outcome Measures

Name	Time	Method
Change in Total Nasal Symptom Score After Nasal Challenge With Allergen Versus Diluent	Day 2 after one week pretreatment with Nasaleze or placebo.	Change in total nasal symptom score after nasal challenges (the change is calculated as the total nasal symptom score after allergen challenge - total nasal symptom score after diluent challenge) on the second of two days of nasal challenges following one week of pretreatment with Nasaleze or placebo. The nasal symptoms included number of sneezes, symptoms of runny and stuffy nose (separately for each nostril), and itchy nose/throat symptoms. Individual symptoms were score on a scale from 0-3 (0=no symptoms, 1=mild, 2=moderate, 3=severe). The maximum total nasal symptom score possible was 15 with higher scores indicating worse symptoms.

Trial Locations

Locations (1)

University of Chicago; 🇺🇸 Chicago, Illinois, United States