Pulmozyme in Cystic Fibrosis With Sinusitis

Withdrawn before enrolling · Phase 3 · Has a placebo group

Conditions studied: Sinusitis, Cystic Fibrosis

In brief

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.

Key facts

Study ID

NCT01155752

Run by

Milton S. Hershey Medical Center

People needed

0

Starts

2013-07-01

Expected to finish

2015-06-01

Last updated by the study team

2017-07-21

Who can join

Age: 12 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• Penn State Unicersity — Hershey, Pennsylvania, United States

Full record on ClinicalTrials.gov

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