- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00425165
Study of Denufosol Inhalation Solution in Patients With Mild to Moderate Cystic Fibrosis Lung Disease
March 17, 2015 updated by: Merck Sharp & Dohme LLC
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
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
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
6
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in mucociliary clearance from baseline
Time Frame: 30, 60, and 90 minutes post aerosol inhalation
|
30, 60, and 90 minutes post aerosol inhalation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2007
Primary Completion (Actual)
May 1, 2008
Study Completion (Actual)
May 1, 2008
Study Registration Dates
First Submitted
January 19, 2007
First Submitted That Met QC Criteria
January 19, 2007
First Posted (Estimate)
January 22, 2007
Study Record Updates
Last Update Posted (Estimate)
April 3, 2015
Last Update Submitted That Met QC Criteria
March 17, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08-111
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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University Hospital, BordeauxCompleted
Clinical Trials on denufosol tetrasodium (INS37217) Inhalation Solution
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Merck Sharp & Dohme LLCCompletedCystic Fibrosis
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Merck Sharp & Dohme LLCCompletedCystic FibrosisUnited States, Australia, Canada, New Zealand
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Merck Sharp & Dohme LLCWithdrawn
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Merck Sharp & Dohme LLCTerminatedUveitis | Cystoid Macular Edema
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Merck Sharp & Dohme LLCTerminatedRetinal DetachmentUnited States
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Merck Sharp & Dohme LLCCompleted
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Merck Sharp & Dohme LLCCystic Fibrosis FoundationCompleted