CompletedPhase 2/3

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

United States20 participantsStarted 2010-01

Plain-language 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.

Who can participate

Age range18 Days – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Change in Sneezing Symptom

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

Change in Runny Nose Symptom

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

Change in Stuffy Nose Symptom

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

Change in Itching Symptom

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

Trial details

NCT IDNCT00791102

SponsorUniversity of Chicago

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-09

Results submitted2013-03-06

View on ClinicalTrials.gov More Allergic Rhinitis trials

Who can participate

Age range18 Days – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Change in Sneezing Symptom

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

Change in Runny Nose Symptom

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

Change in Stuffy Nose Symptom

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

Change in Itching Symptom

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