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Completed

NCT Number: NCT00791102

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

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.

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Key information

Conditions

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

Age range

18 day–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

ASP-1001 nasal spray

Drug

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

Placebo for ASP-1001

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • Asphelia Pharmaceuticals

Registry information

Official study 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)

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Nov 14, 2008
Registry last updated
Jul 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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