Study of Denufosol Inhalation Solution in Patients With Mild Cystic Fibrosis Lung Disease
October 9, 2015 updated by: Merck Sharp & Dohme LLC
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
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
352
Phase
- Phase 3
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
5 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 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
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: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 2
|
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.
|
|
Placebo Comparator: 1
Placebo
|
4.2 mL of solution, allowing delivery of approximately 4 mL into the nebulizer cup for nebulization, three times daily for six months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in lung function
Time Frame: 48 weeks
|
48 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Pulmonary exacerbation
Time Frame: 48 weeks
|
48 weeks
|
|
Requirements for concomitant CF medications
Time Frame: 48 weeks
|
48 weeks
|
|
Quality of Life
Time Frame: 48 weeks
|
48 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
July 1, 2006
Primary Completion (Actual)
September 1, 2008
Study Completion (Actual)
September 1, 2008
Study Registration Dates
First Submitted
July 25, 2006
First Submitted That Met QC Criteria
July 26, 2006
First Posted (Estimate)
July 27, 2006
Study Record Updates
Last Update Posted (Estimate)
November 4, 2015
Last Update Submitted That Met QC Criteria
October 9, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08-108
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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.