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

Allergic Rhinitis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00791102
• Other study ID #: 16504B (ASP2002-AR-01)
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 13, 2008
• Last updated: July 8, 2013
• Start date: January 2010
• Est. completion date: December 2010

Study information

• Verified date: July 2013
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinitis

Intervention

Drug:
• ASP-1001 nasal spray
2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge.
• Placebo for ASP-1001
2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge.

Locations

Country	Name	City	State
United States	University of Chicago Medical Center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	Asphelia Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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.	15 minutes after diluent challenge and 15 minutes after each antigen challenge	No
Secondary	Change in Nasal Peak Inspiratory Flow Measurements From Before to After Treatment		15 minutes prior to treatment and 15 minutes post antigen challenges	No