Back to resultsStudy of Denufosol Tetrasodium in Patients With Cystic Fibrosis Lung Disease
Primary Purpose
Cystic Fibrosis
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
denufosol tetrasodium (INS37217)
Sponsored by
About this trial
This is an interventional treatment trial for Cystic Fibrosis focused on measuring lung disease
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
respiratory function
Secondary Outcome Measures
adverse events
change in standard safety parameters
respiratory symptoms via questionnaire
pulmonary exacerbation
Full Information
NCT ID
NCT00103714
First Posted
February 14, 2005
Last Updated
October 19, 2015
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00103714
Brief Title
Study of Denufosol Tetrasodium in Patients With Cystic Fibrosis Lung Disease
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
August 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
lung disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
denufosol tetrasodium (INS37217)
Primary Outcome Measure Information:
Title
respiratory function
Secondary Outcome Measure Information:
Title
adverse events
Title
change in standard safety parameters
Title
respiratory symptoms via questionnaire
Title
pulmonary exacerbation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy Schaberg, BSN
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Study of Denufosol Tetrasodium in Patients With Cystic Fibrosis Lung Disease
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