A Study in Adult and Pediatric Patients With Cystic Fibrosis
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The purpose of this ascending dose group study is to assess the safety, tolerability, and effects of multiple dose levels of INS37217 and placebo followed by five days twice daily treatment with maximum tolerated dose administered by inhalation via the Pari LC Star nebulizer in adult and pediatric patients with cystic fibrosis
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Layout table for eligibility information
Ages Eligible for Study:
5 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
FEV1 40-70% (adults)
FEV1 >/=50% (pediatrics)
oxygen saturation >90%
willing to stay overnight
abnormal renal or liver function
receiving corticosteroids exceeding 10mg/day or 20 mg every other day
received intravenous or aerosolized antibiotics 1 week prior to dosing