Pulmozyme in Cystic Fibrosis With Sinusitis

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01155752
• Date of registration: 25/06/2010
• Prospective Registration: Yes
• Primary sponsor: Milton S. Hershey Medical Center
• Public title: Pulmozyme in Cystic Fibrosis With Sinusitis
• Scientific title: Z4770s, Use of Recombinant Human DNASE in Cystic Fibrosis Patients With Chronic Sinusitis to Prevent Acute Sinusitis Exacerbations and Improve Symptoms and Outcomes - A Pilot Study
• Date of first enrolment: July 2013
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT01155752
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: Timothy Craig, DO
• Affiliation: Penn State University

Key inclusion & exclusion 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.



Age minimum: 12 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Sinusitis

Intervention(s)

Drug: placebo

Drug: Pulmozyme single use ampule

Primary Outcome(s)

1. To assess changes in quality of life of patients with Cystic Fibrosis while on DNASE as compared to placebo. [Time Frame: weeks]

Secondary ID(s)

IRB#33344

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Genentech, Inc.