Status:
WITHDRAWN
Pulmozyme in Cystic Fibrosis With Sinusitis
Lead Sponsor:
Milton S. Hershey Medical Center
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Sinusitis
Cystic Fibrosis
Eligibility:
All Genders
12-65 years
Phase:
PHASE3
Brief Summary
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.
Detailed Description
The study will be a prospective enrollment of patients with CF and rhinosinusitis in a double-blind crossover study with nasal nebulized DNASE versus saline. Nebulization will be accomplished with PAR...
Eligibility Criteria
Inclusion
- Patients with CF, age \>15yo
- Chronic sinusitis with symptoms
- VAS score of at least 60 (0 to 100) reflecting symptoms associated with rhinosinusitis
- CT scan demonstrating non-complicated sinusitis (defined as rhinosinusitis without orbit perforation, osteomyelitis, peri-sinus cellulitis, or meningitis)
Exclusion
- No evidence of sinusitis
- VAS score for rhinosinusitis less than 60 on a scale of 0 to 100
- Complicated sinusitis (defined as orbit perforation, osteomyelitis, peri-sinus cellulitis, meningitis complicating sinusitis)
- Prior adverse events or allergy to DNASE
- Unwilling to sign an approved IRB consent
- Immediate indication for sinus surgery
- Inability to adhere to therapy and understand and to complete questionnaires.
- 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.
- Active nursing of an infant will be an exclusion.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01155752
Start Date
July 1 2013
End Date
June 1 2015
Last Update
July 21 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Penn State Unicersity
Hershey, Pennsylvania, United States, 17033