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

• ClinicalTrials.gov Identifier: NCT00791102
• Recruitment Status: Completed
• First Posted: November 14, 2008
• Results First Posted: July 10, 2013
• Last Update Posted: July 10, 2013
• Sponsor: University of Chicago
• Collaborator: Asphelia Pharmaceuticals
• Information provided by (Responsible Party): Robert Naclerio, University of Chicago

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Allergic Rhinitis	Drug: ASP-1001 nasal spray; Drug: Placebo for ASP-1001	Phase 2; Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Trial of Topical ASP-1001 (Contrast Media Formulation) in the Prevention of the Signs and Symptoms of the Acute Response to Nasal Allergen Challenge (NAC)
• Study Start Date: January 2010
• Actual Primary Completion Date: September 2010
• Actual Study Completion Date: December 2010

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 1; Topical ASP-1001	Drug: ASP-1001 nasal spray; 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge.
Placebo Comparator: 2; Placebo for Topical ASP-1001	Drug: Placebo for ASP-1001; 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge.

Outcome Measures

Primary Outcome Measures :

1. Change in Sneezing Symptom [ Time Frame: 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.
2. Change in Runny Nose Symptom [ Time Frame: 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.
3. Change in Stuffy Nose Symptom [ Time Frame: 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.
4. Change in Itching Symptom [ Time Frame: 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.

Secondary Outcome Measures :

1. Nasal Peak Inspiratory Flow Measurements [ Time Frame: 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.
2. 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 ]

Eligibility Criteria

• Ages Eligible for Study: up to 55 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.
2. Pregnant or lactating women.
3. Upper respiratory infection or sinusitis within 14 days of study start.
4. Use of nasal steroids, antihistamines in the last 2 weeks.
5. FEV1<80% of predicted at screening for subjects with history of mild asthma
6. current smokers or recent ex-smokers
7. 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.

Contacts and Locations

Locations

United States, Illinois

University of Chicago Medical Center

Chicago, Illinois, United States, 60637

Sponsors and Collaborators

University of Chicago

Asphelia Pharmaceuticals

Investigators

• Principal Investigator: Robert Naclerio, MD; University of Chicago

More Information

• Responsible Party: Robert Naclerio, Professor, University of Chicago
• ClinicalTrials.gov Identifier: NCT00791102
• Other Study ID Numbers: 16504B (ASP2002-AR-01)
• First Posted: November 14, 2008
• Results First Posted: July 10, 2013
• Last Update Posted: July 10, 2013
• Last Verified: July 2013

Additional relevant MeSH terms:

Rhinitis; Rhinitis, Allergic; Nose Diseases; Respiratory Tract Diseases; Respiratory Tract Infections; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases