Phase 3
Completed N=20
Topical ASP-1001 (Contrast Media Formulation) and the Acute Response to Nasal Allergen Challenge (NAC)
Source: ClinicalTrials.gov NCT00791102 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jul 2013
Primary outcomePrimary: Change in Sneezing Symptom — 1; 1 sneezes
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Sneezing Symptom |
1; 1 | — |
| PRIMARY Change in Runny Nose Symptom |
1; 2.5 | — |
| PRIMARY Change in Stuffy Nose Symptom |
1; 2 | — |
| PRIMARY Change in Itching Symptom |
0; 1 | — |
| SECONDARY Nasal Peak Inspiratory Flow Measurements |
-8.5; -30 | — |
| SECONDARY Change in Nasal Peak Inspiratory Flow Measurements From Before to After Treatment |
-7.5; -10 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00791102). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.