A Trial of Pulmozyme Withdrawal on Exercise Tolerance in Cystic Fibrosis Subjects With Severe Lung Disease (TOPIC)

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Cystic Fibrosis

In brief

This was a multicenter, randomized, double-blind, placebo-controlled study of patients with severe, though stable, cystic fibrosis (CF) whose routine treatment included Pulmozyme. Patients were randomized to either continue Pulmozyme or have therapy withdrawn for 2 weeks (placebo group). Patients must have had stable CF symptoms without any change in therapy for 2 weeks prior to enrollment in order to participate.

Key facts

Study ID

NCT00434278

Run by

Genentech, Inc.

People needed

27

Starts

2007-03-01

Expected to finish

2008-11-01

Last updated by the study team

2017-05-16

Who can join

Age: 14 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed Informed Consent Form and, if applicable, Assent Form
• 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

You may not qualify if…

• Use of an investigational drug or device within 28 days prior to screening
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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