Trial Outcomes & Findings for Effect of Nasaleze on Nasal Challenge With Allergen (NCT NCT01723397)

Last Updated: 2017-01-02

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

14 participants

Primary outcome timeframe

Day 2 after one week pretreatment with Nasaleze or placebo.

Results posted on

2017-01-02

Participant Flow

Participant milestones

Participant milestones
Measure	Nasaleze Spray, Then Placebo Spray This group first received Nasaleze spray 1 puff via "spray device" in each nostril 3 times daily for 1 week followed by allergen (either grass or ragweed) challenge, then after a 1 week washout received placebo spray 1 puff via "spray device" in each nostril 3 times daily for 1 week followed by allergen challenge	Placebo Spray, Then Nasaleze Spray This group first received Placebo spray 1 puff via "spray device" in each nostril 3 times daily for 1 week followed by allergen (grass or ragweed) challenge, followed by a 1 week washout and then received Nasaleze spray 1 puff via "spray device" in each nostril 3 times daily for 1 week followed by allergen challenge
Study Period 1 STARTED	7	7
Study Period 1 COMPLETED	7	6
Study Period 1 NOT COMPLETED	0	1
Washout STARTED	7	6
Washout COMPLETED	7	6
Washout NOT COMPLETED	0	0
Study Period 2 STARTED	7	6
Study Period 2 COMPLETED	7	5
Study Period 2 NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Nasaleze Spray, Then Placebo Spray This group first received Nasaleze spray 1 puff via "spray device" in each nostril 3 times daily for 1 week followed by allergen (either grass or ragweed) challenge, then after a 1 week washout received placebo spray 1 puff via "spray device" in each nostril 3 times daily for 1 week followed by allergen challenge	Placebo Spray, Then Nasaleze Spray This group first received Placebo spray 1 puff via "spray device" in each nostril 3 times daily for 1 week followed by allergen (grass or ragweed) challenge, followed by a 1 week washout and then received Nasaleze spray 1 puff via "spray device" in each nostril 3 times daily for 1 week followed by allergen challenge
Study Period 1 Protocol Violation	0	1
Study Period 2 Protocol Violation	0	1

Baseline Characteristics

Effect of Nasaleze on Nasal Challenge With Allergen

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nasaleze Spray, Then Placebo Spray n=7 Participants This group first received Nasaleze spray 1 puff via "spray device" in each nostril 3 times daily for 1 week followed by allergen (either grass or ragweed) challenge, then after a 1 week washout received placebo spray 1 puff via "spray device" in each nostril 3 times daily for 1 week followed by allergen challenge	Placebo Spray, Then Nasaleze Spray n=7 Participants This group first received placebo spray 1 puff via "spray device" in each nostril 3 times daily for 1 week followed by allergen (either grass or ragweed) challenge, then after a 1 week washout received Nasaleze spray 1 puff via "spray device" in each nostril 3 times daily for 1 week followed by allergen challenge	Total n=14 Participants Total of all reporting groups
Age, Continuous	23.6 years STANDARD_DEVIATION 8.6 • n=5 Participants	28.0 years STANDARD_DEVIATION 7.5 • n=7 Participants	25.8 years STANDARD_DEVIATION 8.1 • n=5 Participants
Gender Female	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Gender Male	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants	7 participants n=7 Participants	14 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 2 after one week pretreatment with Nasaleze or placebo.

Population: The analysis population includes the 12 participants who completed the study.

Outcome measures

Outcome measures
Measure	Nasaleze Spray n=12 Participants Nasaleze spray 1 puff via "spray device" in each nostril 3 times daily for 1 week followed by allergen challenge Nasaleze Spray: Subjects are treated with over the counter Nasaleze cellulose powder nasal spray then challenged with allergen Allergen: Subjects are challenged with grass or ragweed allergen after treatment with Nasaleze or placebo	Placebo Spray n=12 Participants Placebo spray 1 puff via "spray device" in each nostril 3 times daily for 1 week followed by allergen challenge Placebo spray: Subjects are treated with placebo nasal spray then challenged with allergen Allergen: Subjects are challenged with grass or ragweed allergen after treatment with Nasaleze or placebo
Change in Total Nasal Symptom Score After Nasal Challenge With Allergen Versus Diluent	5.5 units on a scale Interval 1.0 to 13.0	5.5 units on a scale Interval 1.0 to 13.0

Adverse Events

Nasaleze Spray

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Spray

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Robert Naclerio

University of Chicago

Phone: 773-702-0080

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place