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

Cystic Fibrosis Clinical Trial

— REACH-1  

Official title:

A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 7-Day Safety and Tolerability Study of Denufosol Tetrasodium Inhalation Solution Administered Via PARI LC® Star in Patients 2 to 4 Years of Age With Cystic Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01181622
• Other study ID #: P08643
• Secondary ID: 08-116
• Status: Completed
• Phase: Phase 2
• First received: August 12, 2010
• Last updated: December 29, 2014
• Start date: August 2010
• Est. completion date: October 2010

Study information

• Verified date: December 2014
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 4 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Drug:
• denufosol tetrasodium Inhalation Solution
60 mg by oral inhalation three times daily
• 0.9% w/v sodium chloride solution
0.9% w/v sodium chloride solution by oral inhalation three times daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intolerability to study drug as measured by: oxyhemoglobin saturation, treatment-emergent cough, and new wheezes or crackles		Day 1, Day 7	Yes
Secondary	Mean change from pre-dose in oxyhemoglobin saturation at defined times post-dose		Day 1, Day 7	Yes
Secondary	Mean change from baseline in oxyhemoglobin saturation		Day 7	Yes
Secondary	Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and/or withdrawals due to TEAEs		Day 7	Yes
Secondary	Mean change from pre-dose in pulse and respiratory rate at defined times post-dose		Day 1, Day 7	Yes
Secondary	Mean change from baseline in pulse and respiratory rate		Day 7	Yes
Secondary	Incidence of new medical condition(s) or worsening of previous medical condition(s) from baseline		Day 7	Yes