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Completed

NCT Number: NCT00056147

Study of INS37217 Inhalation Solution in Mild to Moderate Cystic Fibrosis Lung Disease

The purpose of this study is to assess the safety and effectiveness of multiple dosages of INS37217 compared to placebo over 28 days in subjects with mild to moderate cystic fibrosis (CF) lung disease. Study drug will be administered through a nebulizer (a device that delivers medication as a mist by breathing it in).

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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

8 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

The purpose of this study is to:

  • assess the safety and efficacy of multiple dose levels of INS37217 compared to placebo over 28 days in subjects with mild to moderate CF lung disease;
  • explore evidence of activity of INS37217 and placebo administered via PARI LC STAR nebulizer;
  • identify dose(s) that will be studied in subsequent trials.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • confirmed diagnosis of CF
  • FEV1 greater than or equal to 75% of predicted normal for age, gender, and height
  • oxyhemoglobin saturation greater than or equal to 90%
  • clinically stable

Exclusion criteria

  • abnormal renal or liver function
  • clinically significant findings atypical for moderate cystic fibrosis

Treatment and study plan

denufosol tetrasodium (INS37217)

Drug

Primary outcomes

  1. lung function

  2. respiratory symptoms

  3. sputum weight

  4. pulmonary exacerbations

  5. measures of lung characteristics

Secondary outcomes

  1. safety measures

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Collaborators

  • Cystic Fibrosis Foundation

Registry information

Official study title

Multi-Center, Double-Blind, Randomized, Placebo-Controlled, 28-Day Study of INS37217 Inhalation Solution in Subjects With Mild to Moderate Cystic Fibrosis Lung Disease

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Mar 7, 2003
Registry last updated
Jan 29, 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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