Overview

Pulmozyme in Cystic Fibrosis With Sinusitis

Status:
Withdrawn

Trial end date:
2015-06-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Milton S. Hershey Medical Center
Penn State University

Collaborator:

Genentech, Inc.

Criteria

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.