Back to resultsStudy of Denufosol Inhalation Solution in Patients With Mild Cystic Fibrosis Lung Disease
Primary Purpose
Cystic Fibrosis
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
denufosol tetrasodium (INS37217) Inhalation Solution
Placebo - 0.9% w/v sodium chloride solution
Sponsored by
About this trial
This is an interventional treatment trial for Cystic Fibrosis
Eligibility Criteria
Inclusion Criteria: Have confirmed diagnosis of cystic fibrosis Have FEV1 of greater than or equal to 75% of predicted normal for age, gender, and height Be able to reproducibly perform spirometry maneuvers Be clinically stable for at least 4 weeks prior to screening Exclusion Criteria: Have abnormal renal or liver function Have chest x-ray at screening suggesting clinically significant active pulmonary disease Be colonized with Burkholderia cepacia Have had a lung transplant
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
1
2
Arm Description
Placebo
Outcomes
Primary Outcome Measures
Change in lung function
Secondary Outcome Measures
Pulmonary exacerbation
Requirements for concomitant CF medications
Quality of Life
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00357279
Brief Title
Study of Denufosol Inhalation Solution in Patients With Mild Cystic Fibrosis Lung Disease
Official Title
A Multi-Center, Double-Blind, Placebo-Controlled Randomized, Efficacy and Safety Study of Denufosol Tetrasodium (INS37217) Inhalation Solution in Patients With Mild Cystic Fibrosis Lung Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (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 purpose of this trial is to evaluate the safety and effectiveness of a one dose strength of denufosol compared to placebo in patients with mild CF lung disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
352 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
denufosol tetrasodium (INS37217) Inhalation Solution
Intervention Description
Denufosol 60 mg is administered as an inhalation solution, three times daily for six months during the double-blind portion of the study. Subsequently, denufosol 60 mg is administered for an additional six months during the open label safety extension.
Intervention Type
Drug
Intervention Name(s)
Placebo - 0.9% w/v sodium chloride solution
Intervention Description
4.2 mL of solution, allowing delivery of approximately 4 mL into the nebulizer cup for nebulization, three times daily for six months.
Primary Outcome Measure Information:
Title
Change in lung function
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Pulmonary exacerbation
Time Frame
48 weeks
Title
Requirements for concomitant CF medications
Time Frame
48 weeks
Title
Quality of Life
Time Frame
48 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have confirmed diagnosis of cystic fibrosis
Have FEV1 of greater than or equal to 75% of predicted normal for age, gender, and height
Be able to reproducibly perform spirometry maneuvers
Be clinically stable for at least 4 weeks prior to screening
Exclusion Criteria:
Have abnormal renal or liver function
Have chest x-ray at screening suggesting clinically significant active pulmonary disease
Be colonized with Burkholderia cepacia
Have had a lung transplant
12. IPD Sharing Statement
Citations:
PubMed Identifier
21169471
Citation
Accurso FJ, Moss RB, Wilmott RW, Anbar RD, Schaberg AE, Durham TA, Ramsey BW; TIGER-1 Investigator Study Group. Denufosol tetrasodium in patients with cystic fibrosis and normal to mildly impaired lung function. Am J Respir Crit Care Med. 2011 Mar 1;183(5):627-34. doi: 10.1164/rccm.201008-1267OC. Epub 2010 Dec 17.
Results Reference
derived
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Study of Denufosol Inhalation Solution in Patients With Mild Cystic Fibrosis Lung Disease
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