A Study in Adult and Pediatric Patients With Cystic Fibrosis

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Cystic Fibrosis

Treatments: Drug: denufosol tetrasodium (INS37217) Inhalation Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT00034515

08-102

Details and patient eligibility

About

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

Enrollment: 63 patients

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind