At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 16 enrolled
Drug / intervention
Pulmozyme (dornase alfa) +1 moredrug
Likely dose
Pulmozyme (dornase alfa) 2.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Use of Nasally Delivered Pulmozyme in the Treatment of Sinusitis in Cystic Fibrosis Patients: A Pilot Study
In Brief
A Phase 2 clinical trial evaluating Pulmozyme (dornase alfa) and Placebo for Sinusitis and Cystic Fibrosis. Completed, enrolled 16 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSinusitis, Cystic Fibrosis
CountriesUnited States
CollaboratorsGenentech, Inc.
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2006
First PostedDec 2006
Primary CompletionJun 2012
TodayJul 2026
First PostedDec 27, 2006
Enrollment StartDec 1, 2006
Primary CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 19.5 years ago
Interventions
Pulmozyme (dornase alfa)drug
2.5 mg/2.5 mL of Pulmozyme (dornase alfa) delivered via Sinustar nasal nebulizer device
Placebodrug
2.5 mL of placebo delivered via Sinustar nebulizer device