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Completed

NCT Number: NCT01181622

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

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

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

2 year–4 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

denufosol tetrasodium Inhalation Solution

Drug

60 mg by oral inhalation three times daily

0.9% w/v sodium chloride solution

Drug

0.9% w/v sodium chloride solution by oral inhalation three times daily

Primary outcomes

  1. Intolerability to study drug as measured by: oxyhemoglobin saturation, treatment-emergent cough, and new wheezes or crackles

    Time frame: Day 1, Day 7

Secondary outcomes

  1. Mean change from pre-dose in oxyhemoglobin saturation at defined times post-dose

    Time frame: Day 1, Day 7

  2. Mean change from baseline in oxyhemoglobin saturation

    Time frame: Day 7

  3. Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and/or withdrawals due to TEAEs

    Time frame: Day 7

  4. Mean change from pre-dose in pulse and respiratory rate at defined times post-dose

    Time frame: Day 1, Day 7

  5. Mean change from baseline in pulse and respiratory rate

    Time frame: Day 7

  6. Incidence of new medical condition(s) or worsening of previous medical condition(s) from baseline

    Time frame: Day 7

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Acronym: REACH-1

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Aug 13, 2010
Registry last updated
Jan 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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