A Safety and Tolerability Study of Denufosol in 2-4 Year Olds

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and tolerability of denufosol 60 mg TID in pediatric CF patients 2 to 4 years of age

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

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Have a confirmed diagnosis of CF

• Have oxyhemoglobin saturation ≥ 95% prior to randomization

Exclusion Criteria:

• Have acute intercurrent respiratory infection (cough, wheezing, or new

rhinorrhea or nasal congestion)

• Have any significant medical condition not related to CF

• Unable to discontinue use of hypertonic saline