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

• ClinicalTrials.gov Identifier: NCT01181622
• Recruitment Status: Completed
• First Posted: August 13, 2010
• Last Update Posted: January 13, 2015
• Sponsor: Merck Sharp & Dohme Corp.
• Information provided by (Responsible Party): Merck Sharp & Dohme Corp.

Tracking Information

• First Submitted Date: August 12, 2010
• First Posted Date: August 13, 2010
• Last Update Posted Date: January 13, 2015
• Study Start Date: August 2010
• Actual Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: August 12, 2010): Intolerability to study drug as measured by: oxyhemoglobin saturation, treatment-emergent cough, and new wheezes or crackles [ Time Frame: Day 1, Day 7 ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 12, 2010)

• Mean change from pre-dose in oxyhemoglobin saturation at defined times post-dose [ Time Frame: Day 1, Day 7 ]
• Mean change from baseline in oxyhemoglobin saturation [ Time Frame: Day 7 ]
• Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and/or withdrawals due to TEAEs [ Time Frame: Day 7 ]
• Mean change from pre-dose in pulse and respiratory rate at defined times post-dose [ Time Frame: Day 1, Day 7 ]
• Mean change from baseline in pulse and respiratory rate [ Time Frame: Day 7 ]
• Incidence of new medical condition(s) or worsening of previous medical condition(s) from baseline [ Time Frame: Day 7 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Safety and Tolerability Study of Denufosol in 2-4 Year Olds
• 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
• Brief 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
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Cystic Fibrosis

Intervention

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

Study Arms

• Experimental: denufosol tetrasodium Inhalation Solution
  Intervention: Drug: denufosol tetrasodium Inhalation Solution
• Placebo Comparator: Placebo
  Intervention: Drug: 0.9% w/v sodium chloride solution

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 19, 2010): 25
• Original Estimated Enrollment (submitted: August 12, 2010): 24
• Actual Study Completion Date: October 2010
• Actual Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 2 Years to 4 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided
• Removed Location Countries: United States

Administrative Information

• NCT Number: NCT01181622
• Other Study ID Numbers: P08643; 08-116
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Merck Sharp & Dohme Corp.
• Study Sponsor: Merck Sharp & Dohme Corp.
• Collaborators: Not Provided

Investigators

• Study Director: Lynn Smiley, MD; Medical monitor

• PRS Account: Merck Sharp & Dohme Corp.
• Verification Date: December 2014