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Study of Denufosol Tetrasodium Inhalation Solution in Patients With Cystic Fibrosis (CF) Lung Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00625612
First received: February 12, 2008
Last updated: October 8, 2015
Last verified: October 2015
  Purpose
The purpose of this trial is to evaluate the safety and effectiveness of one dose strength of Denufosol compared to placebo in patients with CF and a predicted FEV1 of greater than or equal to 75% but less than or equal to 110% predicted.

Condition Intervention Phase
Cystic Fibrosis Drug: Denufosol Tetrasodium (INS37217) Inhalation Solution Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Study of Denufosol Tetrasodium Inhalation Solution in Patients With Cystic Fibrosis Lung Disease and FEV1 Greater Than or Equal to 75% Predicted But Less Than or Equal to 110% Predicted

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change in lung function [ Time Frame: 48 weeks ]

Secondary Outcome Measures:
  • Pulmonary Exacerbation, Antibiotic Use, Incidence of Hospitalization/ER visits, Health resource utilization, Quality of Life [ Time Frame: 48 weeks ]

Enrollment: 466
Study Start Date: February 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 2 Drug: Placebo
Placebo - 0.9% w/v sodium chloride solution, three times daily for twelve months.
Experimental: 1
Denufosol Tetrasodium (INS37217) Inhalation Solution
Drug: Denufosol Tetrasodium (INS37217) Inhalation Solution
Drug: Denufosol Tetrasodium (INS37217) Inhalation Solution, Denufosol 60 mg is administered as an inhalation solution, three times daily for twelve months.

  Eligibility

Ages Eligible for Study:   5 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have confirmed diagnosis of cystic fibrosis
  • Have FEV1 of greater than or equal to 75% but less than or equal to 110%predicted normal for age, gender and height
  • Be able to reproducibly perform spirometry
  • Be clinically stable for at least 4 weeks before screening

Exclusion Criteria:

  • Have abnormal renal or liver function
  • Have lung transplant
  • Unable to discontinue use of hypertonic saline
  • Participated in Inspire trial 08-108
  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: NCT00625612

  Show 106 Study Locations
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Felix Ratjen, MD, PhD Toronto, Canada
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00625612     History of Changes
Other Study ID Numbers: P08640
08-110
Study First Received: February 12, 2008
Last Updated: October 8, 2015

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

ClinicalTrials.gov processed this record on July 21, 2017