Sinusitis | Pulmozyme in Cystic Fibrosis With Sinusitis
Sinusitis research study
What is the primary objective of this study?
The hypothesis is that the intranasal use of Pulmozyme will decrease the severity of sinusitis in Cystic Fibrosis and lead to an improved quality of life.
Who is eligible to participate?
Inclusion Criteria: 1. Patients with CF, age >15yo 2. Chronic sinusitis with symptoms 3. VAS score of at least 60 (0 to 100) reflecting symptoms associated with rhinosinusitis 4. CT scan demonstrating non-complicated sinusitis (defined as rhinosinusitis without orbit perforation, osteomyelitis, peri-sinus cellulitis, or meningitis) Exclusion Criteria: 1. No evidence of sinusitis 2. VAS score for rhinosinusitis less than 60 on a scale of 0 to 100 3. Complicated sinusitis (defined as orbit perforation, osteomyelitis, peri-sinus cellulitis, meningitis complicating sinusitis) 4. Prior adverse events or allergy to DNASE 5. Unwilling to sign an approved IRB consent 6. Immediate indication for sinus surgery 7. Inability to adhere to therapy and understand and to complete questionnaires. 8. Being pregnant will exclude a subject from participating and the subjects will be requested to take birth control methods if actively engaging in sex. Further more, subjects will be requested to inform the investigators if they become pregnant. Pregnancy test will be performed at screening. 9. Active nursing of an infant will be an exclusion.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Pulmozyme single use ampule• Each Pulmozyme single use ampule delivers 2.5 mL (2.5 mg) of the sterile solution to the nebulizer bowl. The aqueous solution contains 1.0 mg/mL dornase alfa, 0.15 mg/mL calcium chloride dihydrate, and 8.77 mg/mL sodium chloride.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
placebocross over to placebo
Start Date: July 2013
Completed Date: June 2015
Phase: Phase 3
Primary Outcome: 1. To assess changes in quality of life of patients with Cystic Fibrosis while on DNASE as compared to placebo.
Study sponsors, principal investigator, and references
Principal Investigator: Timothy Craig, DO
Lead Sponsor: Milton S. Hershey Medical Center
Collaborator: Genentech, Inc.