Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genentech, Inc.
Age
14–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
Clareo Health | A Trial of Pulmozyme Withdrawal on Exercise Tolerance in Cystic Fibrosis Subjects With Severe Lung Disease (TOPIC)
