Ampio Pharma (AMPE) Reports Low-Dose Intranasal Danazol has Impact on Allergic Rhinitis
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Ampio Pharmaceuticals, Inc. (Nasdaq: AMPE) has demonstrated in an IRB approved, randomized, placebo controlled, double-blinded proof of concept study, that low dose intranasal danazol has an impact on allergic rhinitis, a clinical condition in which increases in vascular permeability and edema are hallmark signs.
The study was not powered to show statistical significance as an effective treatment for rhinitis but rather intended to investigate the effect of danazol in a clinical condition associated with vascular permeability and edema. After a 7 day washout period, patients were treated twice a day for 14 days with either placebo (n=10) or low-dose intranasal danazol (n=10) and assessed two times per day (AM and PM) using the validated Total Nasal Symptom Score (TNSS). A larger decrease in TNSS indicates a greater improvement in symptoms. A comparison of the PM score showed a strong trend toward efficacy, with a total mean change between washout and treatment of -2.39 for the treatment group compared to -0.34 for the placebo (p=0.10).
The study was not powered to show statistical significance as an effective treatment for rhinitis but rather intended to investigate the effect of danazol in a clinical condition associated with vascular permeability and edema. After a 7 day washout period, patients were treated twice a day for 14 days with either placebo (n=10) or low-dose intranasal danazol (n=10) and assessed two times per day (AM and PM) using the validated Total Nasal Symptom Score (TNSS). A larger decrease in TNSS indicates a greater improvement in symptoms. A comparison of the PM score showed a strong trend toward efficacy, with a total mean change between washout and treatment of -2.39 for the treatment group compared to -0.34 for the placebo (p=0.10).
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