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ICSA2007 Symposium, 6/5/07 Panel Session Shuyen Ho First Example in Respiratory Area  Steroid Nasal Spray  Seasonal Allergic Rhinitis, Age  12 yr 

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Presentation on theme: "ICSA2007 Symposium, 6/5/07 Panel Session Shuyen Ho First Example in Respiratory Area  Steroid Nasal Spray  Seasonal Allergic Rhinitis, Age  12 yr "— Presentation transcript:

1 ICSA2007 Symposium, 6/5/07 Panel Session Shuyen Ho First Example in Respiratory Area  Steroid Nasal Spray  Seasonal Allergic Rhinitis, Age  12 yr  Randomized, Double-Blind, Parallel-Group  5-21 Days of Screening Followed by 2 Weeks of Treatment  Placebo, 50mcg, 100mcg, 200mcg, 400mcg,  ~ 125 Patients/Treatment.

2 ICSA2007 Symposium, 6/5/07 Panel Session Shuyen Ho Primary Efficacy & Key Safety Endpoints  Mean change from baseline over the entire treatment period in daily, reflective total nasal symptom scores (rTNSS)  Adverse events  24-hour urinary cortisol excretion

3 ICSA2007 Symposium, 6/5/07 Panel Session Shuyen Ho Primary Efficacy Endpoint Mean Change in Daily rTNSS over Treatment Period Day

4 ICSA2007 Symposium, 6/5/07 Panel Session Shuyen Ho Primary Efficacy Endpoint Mean Change in Daily rTNSS over Entire Treatment Period

5 ICSA2007 Symposium, 6/5/07 Panel Session Shuyen Ho Onset of Action Mean Change in AM Pre-dose iTNSS Hour

6 ICSA2007 Symposium, 6/5/07 Panel Session Shuyen Ho “Important” Efficacy Endpoint Mean changes in AM pre-dose iTOSS over Entire Treatment Period

7 ICSA2007 Symposium, 6/5/07 Panel Session Shuyen Ho Adverse Events during Treatment Period

8 ICSA2007 Symposium, 6/5/07 Panel Session Shuyen Ho 24-hour Urinary Cortisol Excretion Change from Baseline to Week 2 (UC pop)

9 ICSA2007 Symposium, 6/5/07 Panel Session Shuyen Ho Dose Selection  Which dose would you choose?  Why?

10 ICSA2007 Symposium, 6/5/07 Panel Session Shuyen Ho Discussion  Flat Dose Response Pattern for steroids, once a particular does starts to work, all higher doses work?  Why not study more lower doses, e.g. 25 mcg, or even 12.5 mcg?  Why not use active control (market leader) to better asses relative efficacy and safety?  Why not wait until the final formulation and final device are developed?

11 ICSA2007 Symposium, 6/5/07 Panel Session Shuyen Ho Second Example in Respiratory Area  A Novel Compound  COPD (Chronic Obstructive Pulmonary Disease) – Smoker’s Lung  Randomized, Double-Blind, Parallel-Group, >40 yrs  2 Weeks Run-in Followed by 4 Weeks of Treatment  Placebo, 5mg, 10mg, 15mg.  ~105 Patients/Treatment

12 ICSA2007 Symposium, 6/5/07 Panel Session Shuyen Ho One of the Primary Efficacy Endpoints Change from baseline in trough FEV 1 at Endpoint –Measured in AM prior to dosing

13 ICSA2007 Symposium, 6/5/07 Panel Session Shuyen Ho Phase II Study Results Dose5mg10mg15mg FEV 1 (Trt – Plb) 60ml10ml140ml (Endpoint at 4 wks)

14 ICSA2007 Symposium, 6/5/07 Panel Session Shuyen Ho Phase III Study Results Study 1234 FEV 1 (15mg-Plb) 40ml20ml30ml30ml (Average Over Time) FEV 1 (15mg-Plb) 80ml40ml30ml40ml (Endpoint at 24 wks)

15 ICSA2007 Symposium, 6/5/07 Panel Session Shuyen Ho Discussion  A successful phase II does ranging study does not guarantee phase III successes – Duh!  Is it Preventable?  If you say yes, then how?

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