A Study in Pediatric Patients With Cystic Fibrosis Lung Disease

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Cystic Fibrosis

Treatments: Drug: denufosol tetrasodium (INS37217)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00130182

08-107

Details and patient eligibility

About

The purpose of this study is to investigate the safety and effectiveness of two dose strengths of study drug compared to placebo in pediatric patients with cystic fibrosis (CF).

Enrollment: 13 patients

Sex: All

Ages: 5 to 7 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have confirmed diagnosis of CF
• Have an FEV1 greater than or equal to 60%
• Have oxygen saturation greater than or equal to 90% on room air
• Be clinically stable for at least 4 weeks prior to screening
• Be able to reproducibly perform spirometry maneuvers

Exclusion criteria

• Have clinically significant comorbidities
• Have changed their physiotherapy technique or schedule within 7 days prior to screening
• Using prior and concurrent medications according to protocol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind