Clareo Health | A Study of the Comparable Efficacy and Safety of Pulmozyme (Dornase Alfa) Delivered by the eRapid Nebulizer System in Patients With Cystic Fibrosis
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genentech, Inc.
Age
6–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male and female patients, \>/= 6 years of age
Confirmed diagnosis of cystic fibrosis (CF)
Receiving Pulmozyme once daily chronically for treatment of CF for at least 6 months prior to screening
Percent predicted FEV1 \>/= 40% at screening based on the Wang (males \< 18 years, females \< 16 years) or Hankinson (males \>/= 18 years, females \>/= 16 years) standardized equations
Able to reproducibly perform spirometry testing and comply with study assessments
You may not be if
An acute respiratory infection or pulmonary exacerbation within 4 weeks prior to randomization
Initiation of any new chronic therapy (e.g. inhaled corticosteroids, inhaled oral antibiotics, high-dose ibuprofen, hypertonic saline, ivacaftor) for respiratory disease within 4 weeks prior to randomization
Changes in chest physiotherapy schedule within 4 weeks prior to randomization
Hospitalization within 4 weeks prior to randomization
Planned hospitalization during the 6-week study
History of organ transplantation
Participation in an investigational drug or device study within 30 day prior to screening
