A Trial of Pulmozyme Withdrawal on Exercise Tolerance in Cystic Fibrosis Subjects With Severe Lung Disease (TOPIC)
NCT ID: NCT00434278
Last Updated: 2017-05-16
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
27 participants
INTERVENTIONAL
2007-03-31
2008-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
placebo
2.5 mg inhalation dose twice daily for 14±2 days
Dornase alfa
Dornase alfa
2.5 mg inhalation dose twice daily for 14±2 days
Interventions
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Dornase alfa
2.5 mg inhalation dose twice daily for 14±2 days
placebo
2.5 mg inhalation dose twice daily for 14±2 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age ≥ 14 years old at screening
* Proven diagnosis of CF
* Ability to perform acceptable and reproducible spirometry maneuvers at screening
* FVC ≤ 45% predicted for race, height, age, and sex at screening
* Chronic use of Pulmozyme for at least 3 months in the last year and daily or twice daily use during the 14 days prior to screening
* Stable regimen of chest physiotherapy (CPT) for at least 14 days prior to screening
* Ability to complete the 6-minute walk test at screening
* Ability to complete the 6-minute walk test and spirometry at Visit 2
* If on routine tobramycin solution for inhalation (i.e., TOBI®) or other cycled antibiotic therapy, intention to either start or stop therapy at the time of Visit 2 (based on routine therapy cycle; no other planned change in this antibiotic regimen for 28 days before or 28 days after Visit 2)
* Clinically stable with no change in medications during the 14 days prior to screening
Exclusion Criteria
* Previous episode of acute respiratory failure requiring assisted ventilation within 2 years prior to screening
* Previous lung transplant
* Any cardiac disease that would contraindicate performing the 6-minute walk test
* Pregnancy or nursing
* Known hypersensitivity or other contraindication to the use of Pulmozyme
* Previous completion or premature discontinuation of study drug or withdrawal from this study
* More than one prior screening failure for this study at any time or any prior screening failure for this study within the last 28 days
14 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Michelle Freemer, M.D.
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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University of Alabama
Birmingham, Alabama, United States
Childrens Hospital of LA
Los Angeles, California, United States
USC Adult CF Center
Los Angeles, California, United States
CHOC
Orange, California, United States
Capital Allergy Resp Dis Ctr
Sacramento, California, United States
Ventura County Medical Ctr
Ventura, California, United States
Nat'l Jewish Med/Research Ctr
Denver, Colorado, United States
Pulm & Critical Care Assoc
Jacksonville, Florida, United States
Univ of Miami
Miami, Florida, United States
Central Florida Pulmonary Grou
Orlando, Florida, United States
Brown Univ School of Medicine
Atlanta, Georgia, United States
Medical College of Georgia
Augusta, Georgia, United States
Rush Medical Center
Chicago, Illinois, United States
Univ of Kentucky Med Ctr
Lexington, Kentucky, United States
Univ of Michigan Hlth System
Ann Arbor, Michigan, United States
Wayne State University
Detroit, Michigan, United States
Spectrum Hospital
Grand Rapids, Michigan, United States
Michigan State University
Kalamazoo, Michigan, United States
Univ of Minnesota Dept of Derm
Minneapolis, Minnesota, United States
University of Mississippi
Jackson, Mississippi, United States
Pulmonary & Critical Care Med
St Louis, Missouri, United States
Children's Lung Specialist
Las Vegas, Nevada, United States
Monmouth Medical Center
Long Branch, New Jersey, United States
Morristown Memorial Hospital
Morristown, New Jersey, United States
St. Peters Univ Hospital
New Brunswick, New Jersey, United States
University of New Mexico
Albuquerque, New Mexico, United States
Albany Medical College
Albany, New York, United States
Long Island Jew Adult CF Ctr
New Hyde Park, New York, United States
SUNY Upstate Medical Univ
Syracuse, New York, United States
Duke Pediatric Clinical
Durham, North Carolina, United States
Rainbow Babies & Child Hosp
Cleveland, Ohio, United States
Toledo Childrens Hospital
Toledo, Ohio, United States
Santiago Reyes MD-Private Prac
Oklahoma City, Oklahoma, United States
CF Solutions, Inc
Tulsa, Oklahoma, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Medical Univ of South Carolina
Charleston, South Carolina, United States
Pediatric Pulmonary Assoc
Columbia, South Carolina, United States
Baylor College of Medicine
Houston, Texas, United States
Alamo Clinical Research Assoc
San Antonio, Texas, United States
W Virginia Univ Health Sci Ctr
Morgantown, West Virginia, United States
Countries
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Other Identifiers
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Z3877g
Identifier Type: -
Identifier Source: org_study_id
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