A Safety and Tolerability Study of Denufosol in 2-4 Year Olds (REACH-1)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Cystic Fibrosis

Treatments: Drug: denufosol tetrasodium Inhalation Solution; Drug: 0.9% w/v sodium chloride solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT01181622

08-116

P08643

Details and patient eligibility

About

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

Enrollment: 25 patients

Sex: All

Ages: 2 to 4 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

25 participants in 2 patient groups, including a placebo group

denufosol tetrasodium Inhalation Solution

Experimental group

Treatment:

Drug: denufosol tetrasodium Inhalation Solution

Placebo

Placebo Comparator group

Treatment:

Drug: 0.9% w/v sodium chloride solution