Study of Denufosol Tetrasodium in Patients With Cystic Fibrosis Lung Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00103714
First received: February 14, 2005
Last updated: November 15, 2013
Last verified: November 2013
  Purpose

The objectives of this study are to evaluate the safety, tolerability and preliminary efficacy of two dose levels of INS37217 (denufosol tetrasodium) Inhalation Solution in patients with cystic fibrosis (CF) lung disease.


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: A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, 28-Day Study of Denufosol Tetrasodium (INS37217) Inhalation Solution in Patients With Cystic Fibrosis Lung Disease

Resource links provided by NLM:


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

Primary Outcome Measures:
  • respiratory function

Secondary Outcome Measures:
  • adverse events
  • change in standard safety parameters
  • respiratory symptoms via questionnaire
  • pulmonary exacerbation

Enrollment: 72
Study Start Date: January 2005
Study Completion Date: August 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
  Eligibility

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

Inclusion Criteria:

  • Have confirmed diagnosis of CF
  • Have an FEV1 greater than or equal to 60% or less than or equal to 90% of predicted normal
  • Have oxygen saturation greater than or equal to 90% on room air
  • Be clinically stable with no evidence of acute upper or lower respiratory tract infection or current pulmonary exacerbation
  • Be able to reproducibly perform spirometry maneuvers

Exclusion Criteria:

  • Have changed their physiotherapy technique or schedule within 7 days prior to screening
  • Have clinically significant comorbidities
  • Using prior and concurrent medications according to the protocol
  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: NCT00103714

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

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00103714     History of Changes
Other Study ID Numbers: 08-104
Study First Received: February 14, 2005
Last Updated: November 15, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
lung disease

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 August 28, 2014