A Study in Adult and Pediatric Patients With Cystic Fibrosis

• Status: Completed
• Trial end date: 2002-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.

Criteria

Inclusion Criteria:

• FEV1 40-70% (adults)

• FEV1 >/=50% (pediatrics)

• oxygen saturation >90%

• clinically stable

• willing to stay overnight

Exclusion Criteria:

• 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