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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00056147
First Posted: March 7, 2003
Last Update Posted: January 29, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Cystic Fibrosis Foundation Therapeutics
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   8 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00056147


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Cystic Fibrosis Foundation Therapeutics
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
First Submitted: March 6, 2003
First Posted: March 7, 2003
Last Update Posted: January 29, 2015
Last Verified: January 2015

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

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