Phase 2
N=16
Nasally Delivered Pulmozyme for Sinusitis in Cystic Fibrosis
Sinusitis · Cystic Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT00416182 ↗Enrolled (actual)
16
Serious AEs
18.8%
Results posted
Nov 2014
Primary outcome: Primary: Computed Tomography Evidence of Less Sinus Disease — 5.875; 3 units on a scale — p=0.2
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Pulmozyme (dornase alfa) (Drug); Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult · 5+ yrs
- Sex
- All
- Sponsor
- University of Vermont
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Computed Tomography Evidence of Less Sinus Disease |
5.875; 3 | 0.2 |
| PRIMARY Improvement in Appearance of Nasal Passages/Sinuses |
0.2; -1 | 0.048 sig |
| SECONDARY Chronic Sinusitis Survey Score |
8.5; 3 | 0.003 sig |
| SECONDARY Pulmonary Function |
0.8; 5.4 | 0.4 |
Summary
Chronic sinusitis is a frequent complication in cystic fibrosis. The aim of this study is to determine whether Pulmozyme(dornase alfa) would maintain sinus health (compared to placebo) in patients with cystic fibrosis who have recently undergone sinus surgery.
Eligibility Criteria
Inclusion Criteria
- Clinical and laboratory diagnosis of cystic fibrosis
- Age greater than or equal to 5 years
- Forced expiratory volume in 1 second (FEV1) greater than or equal to 40% predicted
- Sinus surgery within one week of enrollment
Exclusion Criteria
- Pregnancy
- Intolerance of orally inhaled Pulmozyme (dornase alfa)
Data sourced from ClinicalTrials.gov (NCT00416182). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.