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Completed

NCT Number: NCT00357279

Study of Denufosol Inhalation Solution in Patients With Mild Cystic Fibrosis Lung Disease

The purpose of this trial is to evaluate the safety and effectiveness of a one dose strength of denufosol compared to placebo in patients with mild CF lung disease.

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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

5 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Have confirmed diagnosis of cystic fibrosis
  • Have FEV1 of greater than or equal to 75% of predicted normal for age, gender, and height
  • Be able to reproducibly perform spirometry maneuvers
  • Be clinically stable for at least 4 weeks prior to screening

Exclusion criteria

  • Have abnormal renal or liver function
  • Have chest x-ray at screening suggesting clinically significant active pulmonary disease
  • Be colonized with Burkholderia cepacia
  • Have had a lung transplant

Treatment and study plan

Denufosol Tetrasodium (INS37217) Inhalation Solution

Drug

Denufosol 60 mg is administered as an inhalation solution, three times daily for six months during the double-blind portion of the study. Subsequently, denufosol 60 mg is administered for an additional six months during the open label safety extension.

Placebo - 0.9% w/v sodium chloride solution

Drug

4.2 mL of solution, allowing delivery of approximately 4 mL into the nebulizer cup for nebulization, three times daily for six months.

Primary outcomes

  1. Change in lung function

    Time frame: 48 weeks

Secondary outcomes

  1. Pulmonary exacerbation

    Time frame: 48 weeks

  2. Requirements for concomitant CF medications

    Time frame: 48 weeks

  3. Quality of Life

    Time frame: 48 weeks

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jul 27, 2006
Registry last updated
Nov 4, 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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