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

This study has been completed.
Sponsor:
Collaborator:
Cystic Fibrosis Foundation
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00056147
First received: March 6, 2003
Last updated: February 14, 2014
Last verified: February 2014
  Purpose

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).


Condition Intervention Phase
Cystic Fibrosis
Drug: denufosol tetrasodium (INS37217)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • lung function
  • respiratory symptoms
  • sputum weight
  • pulmonary exacerbations
  • measures of lung characteristics

Secondary Outcome Measures:
  • safety measures

Enrollment: 90
Study Start Date: April 2003
Study Completion Date: February 2004
Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)
Detailed Description:

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.
  Eligibility

Ages Eligible for Study:   8 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00056147

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Cystic Fibrosis Foundation
Investigators
Study Director: Amy Schaberg, BSN
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00056147     History of Changes
Other Study ID Numbers: 08-103
Study First Received: March 6, 2003
Last Updated: February 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
cystic fibrosis

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Lung Diseases
Pulmonary Fibrosis
Pancreatic Diseases
Digestive System Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014