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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01181622
First received: August 12, 2010
Last updated: January 17, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention Phase
Cystic Fibrosis
Drug: denufosol tetrasodium Inhalation Solution
Drug: 0.9% w/v sodium chloride solution
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Intolerability to study drug as measured by: oxyhemoglobin saturation, treatment-emergent cough, and new wheezes or crackles [ Time Frame: Day 1, Day 7 ] [ Designated as safety issue: Yes ]

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

Enrollment: 25
Study Start Date: August 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: denufosol tetrasodium Inhalation Solution Drug: denufosol tetrasodium Inhalation Solution
60 mg by oral inhalation three times daily
Placebo Comparator: Placebo Drug: 0.9% w/v sodium chloride solution
0.9% w/v sodium chloride solution by oral inhalation three times daily

  Eligibility

Ages Eligible for Study:   2 Years to 4 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01181622

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Lynn Smiley, MD Medical monitor
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01181622     History of Changes
Other Study ID Numbers: P08643, 08-116
Study First Received: August 12, 2010
Last Updated: January 17, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014