CompletedNCT00791102Updated Jul 10, 2013Results posted

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

A Phase 2/3 interventional study of ASP-1001 nasal spray and Placebo for ASP-1001 in Allergic Rhinitis, sponsored by University of Chicago. Completed at 1 site in United States. Open to participants aged 18 Days to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-07-10.

Sponsored by University of Chicago · Phase 2/3, Interventional, and Treatment

Phase: Phase 2/3
Study type: Interventional
Enrollment: 20
Allocation: Randomized
Ages: 18 Days to 55 Years
Sex: All

Study summary

The purpose of this study is to see whether ASP-1001 when given as a nasal spray is safe and can reduce the signs and symptoms of allergic rhinitis (hayfever) following nasal challenge with antigen.

Conditions studied

Allergic Rhinitis

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In context

Rhinitis

1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.

This study's enrollment of 20 is below the median of 89 across 906 interventional studies indexed under Rhinitis.

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Lead sponsor

University of Chicago is the lead sponsor of 907 studies on the registry; 182 are open to participants now.

Of its 99 completed or terminated interventional studies of FDA-regulated products, 68 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Days to 55 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Males and females between 18 and 55 years of age.
History of grass and/or ragweed allergic rhinitis.
Positive skin test to grass and/or ragweed antigen.
Positive response to screening nasal challenge.

Exclusion criteria

Exclusion Criteria:

Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.
Pregnant or lactating women.
Upper respiratory infection or sinusitis within 14 days of study start.
Use of nasal steroids, antihistamines in the last 2 weeks.
FEV1\<80% of predicted at screening for subjects with history of mild asthma
current smokers or recent ex-smokers
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.

Study design

Phase: Phase 2 / Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 20 participants (actual)

Study arms

Active comparator
1
Topical ASP-1001
Drug: ASP-1001 nasal spray
Placebo comparator
2
Placebo for Topical ASP-1001
Drug: Placebo for ASP-1001

Interventions

DrugASP-1001 nasal spray
2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge.
DrugPlacebo for ASP-1001
2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge.

What researchers measure

Primary outcomes

Change in Sneezing Symptom
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.
Time frame: 10 minutes after diluent challenge and 10 minutes after each antigen challenge
Change in Runny Nose Symptom
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.
Time frame: 10 minutes after diluent challenge and 10 minutes after each antigen challenge
Change in Stuffy Nose Symptom
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.
Time frame: 10 minutes after diluent challenge and 10 minutes after each antigen challenge
Change in Itching Symptom
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.
Time frame: 10 minutes after diluent challenge and 10 minutes after each antigen challenge

Secondary outcomes

Nasal Peak Inspiratory Flow Measurements
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.
Time frame: 15 minutes after diluent challenge and 15 minutes after each antigen challenge
Change in Nasal Peak Inspiratory Flow Measurements From Before to After Treatment
Time frame: 15 minutes prior to treatment and 15 minutes post antigen challenges

Results

Posted Jul 10, 2013

Participant flow

Period 1

Participant flow — Period 1
Milestone	Topical ASP-1001	Placebo for Topical ASP-1001
Started	10	10
Completed	10	10
Not completed	0	0

Washout Period of 2 Weeks

Participant flow — Washout Period of 2 Weeks
Milestone	Topical ASP-1001	Placebo for Topical ASP-1001
Started	10	10
Completed	10	10
Not completed	0	0

Period 2

Participant flow — Period 2
Milestone	Topical ASP-1001	Placebo for Topical ASP-1001
Started	10	10
Completed	10	10
Not completed	0	0

Outcome measures

PrimaryChange in Sneezing Symptom

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.

Time frame:: 10 minutes after diluent challenge and 10 minutes after each antigen challenge
Reported as:: Median · sneezes

Change in Sneezing Symptom
sneezes	Topical ASP-1001	Placebo for Topical ASP-1001
Change in Sneezing Symptom	1 (0 to 2)	1 (0 to 8)

SecondaryNasal Peak Inspiratory Flow Measurements

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.

Time frame:: 15 minutes after diluent challenge and 15 minutes after each antigen challenge
Reported as:: Median · L/min

Nasal Peak Inspiratory Flow Measurements
L/min	Topical ASP-1001	Placebo for Topical ASP-1001
Nasal Peak Inspiratory Flow Measurements	-8.5 (-51.25 to 3.75)	-30 (-40 to -20)

PrimaryChange in Runny Nose Symptom

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.

Time frame:: 10 minutes after diluent challenge and 10 minutes after each antigen challenge
Reported as:: Median · units on a scale

Change in Runny Nose Symptom
units on a scale	Topical ASP-1001	Placebo for Topical ASP-1001
Change in Runny Nose Symptom	1 (0 to 3)	2.5 (0 to 4)

PrimaryChange in Stuffy Nose Symptom

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.

Time frame:: 10 minutes after diluent challenge and 10 minutes after each antigen challenge
Reported as:: Median · units on a scale

Change in Stuffy Nose Symptom
units on a scale	Topical ASP-1001	Placebo for Topical ASP-1001
Change in Stuffy Nose Symptom	1 (0 to 2.75)	2 (0.25 to 3)

PrimaryChange in Itching Symptom

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.

Time frame:: 10 minutes after diluent challenge and 10 minutes after each antigen challenge
Reported as:: Median · units on a scale

Change in Itching Symptom
units on a scale	Topical ASP-1001	Placebo for Topical ASP-1001
Change in Itching Symptom	0 (0 to 2.75)	1 (0 to 2)

SecondaryChange in Nasal Peak Inspiratory Flow Measurements From Before to After Treatment

Time frame:: 15 minutes prior to treatment and 15 minutes post antigen challenges
Reported as:: Median · L/min

Change in Nasal Peak Inspiratory Flow Measurements From Before to After Treatment
L/min	Topical ASP-1001	Placebo for Topical ASP-1001
Change in Nasal Peak Inspiratory Flow Measurements From Before to After Treatment	-7.5 (-20 to 0)	-10 (-20 to 9.5)

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Topical ASP-1001	—	0/20 (0%)	0/20 (0%)
Placebo for Topical ASP-1001	—	0/20 (0%)	0/20 (0%)

Baseline characteristics

Age Continuous
Age Continuous(years)	All Study Participants
Mean	33 ± 9.4

Sex: Female, Male
Sex: Female, Male(Participants)	All Study Participants
Female	8
Male	12

Study locations

1 site

University of Chicago Medical Center
Chicago, Illinois 60637, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 10, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00791102
Lead sponsor: University of Chicago
Collaborators: Asphelia Pharmaceuticals
Responsible party: Robert Naclerio (Professor, University of Chicago) — Principal investigator
First posted: Nov 14, 2008
Start date: Jan 2010
Primary completion: Sep 2010
Completion: Dec 2010
Results posted: Jul 10, 2013
Last update: Jul 10, 2013

Study contacts

Robert Naclerio, MD

principal investigator · University of Chicago

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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