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

March 6, 2003
February 14, 2014
April 2003
February 2004   (final data collection date for primary outcome measure)
  • lung function
  • respiratory symptoms
  • sputum weight
  • pulmonary exacerbations
  • measures of lung characteristics
Not Provided
Complete list of historical versions of study NCT00056147 on ClinicalTrials.gov Archive Site
safety measures
Not Provided
Not Provided
Not Provided
 
Study of INS37217 Inhalation Solution in Mild to Moderate Cystic Fibrosis Lung Disease
Multi-Center, Double-Blind, Randomized, Placebo-Controlled, 28-Day Study of INS37217 Inhalation Solution in Subjects With 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).

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Cystic Fibrosis
Drug: denufosol tetrasodium (INS37217)
Not Provided
Deterding RR, Lavange LM, Engels JM, Mathews DW, Coquillette SJ, Brody AS, Millard SP, Ramsey BW; Cystic Fibrosis Therapeutics Development Network and the Inspire 08-103 Working Group. Phase 2 randomized safety and efficacy trial of nebulized denufosol tetrasodium in cystic fibrosis. Am J Respir Crit Care Med. 2007 Aug 15;176(4):362-9. Epub 2007 Apr 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
February 2004
February 2004   (final data collection date for primary outcome measure)

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
Both
8 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00056147
08-103
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Cystic Fibrosis Foundation
Study Director: Amy Schaberg, BSN
Merck Sharp & Dohme Corp.
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP