Study of Denufosol Inhalation Solution in Patients With Mild to Moderate Cystic Fibrosis Lung Disease
A Randomized, Double-Blind, Two Way Crossover Evaluation of the Effects of a Single Dose of Denufosol Tetrasodium (INS37217) Inhalation Solution Versus Placebo (0.9% Sodium Chloride Solution) on Mucociliary Clearance in Patients With Mild to Moderate Cystic Fibrosis Lung Disease
1 other identifier
interventional
6
0 countries
N/A
Brief Summary
The purpose of this trial is to evaluate the effects of a single dose of denufosol versus placebo on mucociliary clearance in patients with mild to moderate CF lung disease
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Aug 2007
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 19, 2007
CompletedFirst Posted
Study publicly available on registry
January 22, 2007
CompletedStudy Start
First participant enrolled
August 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedApril 3, 2015
March 1, 2015
9 months
January 19, 2007
March 17, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Change in mucociliary clearance from baseline
30, 60, and 90 minutes post aerosol inhalation
Interventions
Denufosol 60 mg is administered as an inhalation solution one time during the study.
Eligibility Criteria
You may qualify if:
- have confirmed diagnosis of cystic fibrosis
- have FEV1 of greater than or equal to 60% 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
You may not qualify if:
- have abnormal renal or liver function
- have chest x-ray at screening with abnormalities suggesting clinically significant active pulmonary disease
- have had a lung transplant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2007
First Posted
January 22, 2007
Study Start
August 1, 2007
Primary Completion
May 1, 2008
Study Completion
May 1, 2008
Last Updated
April 3, 2015
Record last verified: 2015-03