Clinical models used by CIC

The CIC conducts proof of mechanism studies in subjects with asthma to evaluate the effects of investigational therapy using human models of disease, such as allergen-induced late asthmatic response, allergen PC15, and airway inflammation.

Key features of these studies include:

1. placebo-controlled, parallel-group or crossover design
2. sample size requirement of 20-40 subjects
3. bronchoprovocation with allergen, methacholine and/or mannitol
4. PK/PD and exploratory outcomes
5. well-characterized subjects with mild allergic asthma
6. multiple dosing cohorts, multiple challenges
7. standardized SOPs

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