Trial Outcomes & Findings for Topical ASP-1001 (Contrast Media Formulation) and the Acute Response to Nasal Allergen Challenge (NAC) (NCT NCT00791102)

Results Overview

Sneezes. The change is calculated by adding the number of sneezes following both antigen challenges minus twice the number of sneezes after the diluent challenge.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

20 participants

Primary outcome timeframe

10 minutes after diluent challenge and 10 minutes after each antigen challenge

Results posted on

2013-07-10

Participant Flow

Participant milestones

Participant milestones
Measure	Topical ASP-1001 Topical ASP-1001 ASP-1001 nasal spray : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge.	Placebo for Topical ASP-1001 Placebo for Topical ASP-1001 Placebo for ASP-1001 : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge.
Period 1 STARTED	10	10
Period 1 COMPLETED	10	10
Period 1 NOT COMPLETED	0	0
Washout Period of 2 Weeks STARTED	10	10
Washout Period of 2 Weeks COMPLETED	10	10
Washout Period of 2 Weeks NOT COMPLETED	0	0
Period 2 STARTED	10	10
Period 2 COMPLETED	10	10
Period 2 NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Topical ASP-1001 (Contrast Media Formulation) and the Acute Response to Nasal Allergen Challenge (NAC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=20 Participants
Age Continuous	33 years STANDARD_DEVIATION 9.4 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: 10 minutes after diluent challenge and 10 minutes after each antigen challenge

Sneezes. The change is calculated by adding the number of sneezes following both antigen challenges minus twice the number of sneezes after the diluent challenge.

Outcome measures

Outcome measures
Measure	Topical ASP-1001 n=20 Participants Topical ASP-1001 ASP-1001 nasal spray : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge.	Placebo for Topical ASP-1001 n=20 Participants Placebo for Topical ASP-1001 Placebo for ASP-1001 : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge.
Change in Sneezing Symptom	1 sneezes Interval 0.0 to 2.0	1 sneezes Interval 0.0 to 8.0

PRIMARY outcome

Timeframe: 10 minutes after diluent challenge and 10 minutes after each antigen challenge

The nasal symptoms on a scale of 0-3 (0=no symptoms, 1=mild, 2= moderate, 3= severe). The change is calculated by adding the score of runny nose following both antigen challenges minus twice the score of runny nose after the diluent challenge.

Outcome measures

Outcome measures
Measure	Topical ASP-1001 n=20 Participants Topical ASP-1001 ASP-1001 nasal spray : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge.	Placebo for Topical ASP-1001 n=20 Participants Placebo for Topical ASP-1001 Placebo for ASP-1001 : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge.
Change in Runny Nose Symptom	1 units on a scale Interval 0.0 to 3.0	2.5 units on a scale Interval 0.0 to 4.0

PRIMARY outcome

Timeframe: 10 minutes after diluent challenge and 10 minutes after each antigen challenge

The nasal symptoms on a scale of 0-3 (0=no symptoms, 1=mild, 2= moderate, 3= severe). The change is calculated by adding the score of stuffy nose following both antigen challenges minus twice the score of stuffy nose after the diluent challenge.

Outcome measures

Outcome measures
Measure	Topical ASP-1001 n=20 Participants Topical ASP-1001 ASP-1001 nasal spray : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge.	Placebo for Topical ASP-1001 n=20 Participants Placebo for Topical ASP-1001 Placebo for ASP-1001 : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge.
Change in Stuffy Nose Symptom	1 units on a scale Interval 0.0 to 2.75	2 units on a scale Interval 0.25 to 3.0

PRIMARY outcome

Timeframe: 10 minutes after diluent challenge and 10 minutes after each antigen challenge

The nasal symptoms on a scale of 0-3 (0=no symptoms, 1=mild, 2= moderate, 3= severe). The change is calculated by adding the score of itchy nose following both antigen challenges minus twice the score of itchy nose after the diluent challenge.

Outcome measures

Outcome measures
Measure	Topical ASP-1001 n=20 Participants Topical ASP-1001 ASP-1001 nasal spray : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge.	Placebo for Topical ASP-1001 n=20 Participants Placebo for Topical ASP-1001 Placebo for ASP-1001 : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge.
Change in Itching Symptom	0 units on a scale Interval 0.0 to 2.75	1 units on a scale Interval 0.0 to 2.0

SECONDARY outcome

Timeframe: 15 minutes after diluent challenge and 15 minutes after each antigen challenge

The value of nasal peak inspiratory flow. The change is calculated by adding the values of nasal peak inspiratory flow following both antigen challenges minus twice the value of nasal peak inspiratory flow after the diluent challenge.

Outcome measures

Outcome measures
Measure	Topical ASP-1001 n=20 Participants Topical ASP-1001 ASP-1001 nasal spray : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge.	Placebo for Topical ASP-1001 n=20 Participants Placebo for Topical ASP-1001 Placebo for ASP-1001 : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge.
Nasal Peak Inspiratory Flow Measurements	-8.5 L/min Interval -51.25 to 3.75	-30 L/min Interval -40.0 to -20.0

SECONDARY outcome

Timeframe: 15 minutes prior to treatment and 15 minutes post antigen challenges

Outcome measures

Outcome measures
Measure	Topical ASP-1001 n=20 Participants Topical ASP-1001 ASP-1001 nasal spray : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge.	Placebo for Topical ASP-1001 n=20 Participants Placebo for Topical ASP-1001 Placebo for ASP-1001 : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge.
Change in Nasal Peak Inspiratory Flow Measurements From Before to After Treatment	-7.5 L/min Interval -20.0 to 0.0	-10 L/min Interval -20.0 to 9.5

Adverse Events

Topical ASP-1001

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo for Topical ASP-1001

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

Robert Naclerio, MD

University of Chicago

Phone: 773-702-0080

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place