Skip to main content
OpenTrials
Completed

NCT Number: NCT00103714

Study of Denufosol Tetrasodium in Patients With Cystic Fibrosis Lung Disease

The objectives of this study are to evaluate the safety, tolerability and preliminary efficacy of two dose levels of INS37217 (denufosol tetrasodium) Inhalation Solution in patients with cystic fibrosis (CF) lung disease.

Completed

Looking for future studies?

Notify Me

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

8 year–50 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 confirmed diagnosis of CF
  • Have an FEV1 greater than or equal to 60% or less than or equal to 90% of predicted normal
  • Have oxygen saturation greater than or equal to 90% on room air
  • Be clinically stable with no evidence of acute upper or lower respiratory tract infection or current pulmonary exacerbation
  • Be able to reproducibly perform spirometry maneuvers

Exclusion criteria

  • Have changed their physiotherapy technique or schedule within 7 days prior to screening
  • Have clinically significant comorbidities
  • Using prior and concurrent medications according to the protocol

Treatment and study plan

denufosol tetrasodium (INS37217)

Drug

Primary outcomes

  1. respiratory function

Secondary outcomes

  1. adverse events

  2. change in standard safety parameters

  3. respiratory symptoms via questionnaire

  4. pulmonary exacerbation

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, 28-Day Study of Denufosol Tetrasodium (INS37217) Inhalation Solution in Patients With Cystic Fibrosis Lung Disease

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Feb 15, 2005
Registry last updated
Oct 20, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.