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

NCT00791102 | Completed Phase 2 Results

• 1 other identifier: 16504B (ASP2002-AR-01)
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Rhinitis

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

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

Secondary Outcomes (2)

• Nasal Peak Inspiratory Flow Measurements

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

• Change in Nasal Peak Inspiratory Flow Measurements From Before to After Treatment

  15 minutes prior to treatment and 15 minutes post antigen challenges

Study Arms (2)

1

ACTIVE COMPARATOR

Topical ASP-1001

Drug: ASP-1001 nasal spray

2

PLACEBO COMPARATOR

Placebo for Topical ASP-1001

Drug: Placebo for ASP-1001

Interventions

ASP-1001 nasal spray DRUG

2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge.

1

Placebo for ASP-1001 DRUG

2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge.

2

Eligibility Criteria

• Age: 18 Days - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chicago: lead
• Asphelia Pharmaceuticals: collaborator

Study Sites (1)

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Robert Naclerio, MD
• Organization: University of Chicago

rnacleri@surgery.bsd.uchicago.edu

773-702-0080

Study Officials

• Robert Naclerio, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 13, 2008
• First Posted: November 14, 2008
• Study Start: January 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: December 1, 2010
• Last Updated: July 10, 2013
• Results First Posted: July 10, 2013

Record last verified: 2013-07

Locations

US (1)