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 range

18 Days – 55 Years

Sex

ALL

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

18 Days – 55 Years

Sex

ALL

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