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

This study has been completed.
Sponsor:
Collaborator:
Asphelia Pharmaceuticals
Information provided by (Responsible Party):
Robert Naclerio, University of Chicago
ClinicalTrials.gov Identifier:
NCT00791102
First received: November 13, 2008
Last updated: July 8, 2013
Last verified: July 2013
  Purpose
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 Intervention Phase
Allergic Rhinitis Drug: ASP-1001 nasal spray Drug: Placebo for ASP-1001 Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (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)

Further study details as provided by Robert Naclerio, University of Chicago:

Primary Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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:
  • 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.

  • 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 ]

Enrollment: 20
Study Start Date: January 2010
Study Completion Date: December 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00791102

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     History of Changes
Other Study ID Numbers: 16504B (ASP2002-AR-01)
Study First Received: November 13, 2008
Results First Received: March 6, 2013
Last Updated: July 8, 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

ClinicalTrials.gov processed this record on July 26, 2017