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NCT00416182 · ClinicalTrials.gov registry record · Phase 2

Nasally Delivered Pulmozyme for Sinusitis in Cystic Fibrosis

A Phase 2 study of Cystic Fibrosis and Sinusitis, sponsored by University of Vermont.

Completed
Registry status
Phase 2
Development phase
16
Enrollment target
1
Study location

NCT00416182: Completed Phase 2 study of Cystic Fibrosis and Sinusitis, sponsored by University of Vermont.

NCT00416182 is a Phase 2 study of Cystic Fibrosis and Sinusitis that has completed, run by University of Vermont. The registered enrollment target is 16 participants, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00416182, a Phase 2 study of Cystic Fibrosis and Sinusitis, has completed, sponsored by University of Vermont.

COMPLETED
Registry status
Phase 2
Development phase
16 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

compare sinus CT pre-op (baseline) to one year after initiation of study drug Difference in pre and post scores by Lund-McKay scoring system are reported (1 year minus baseline) The Lund-Mackay scoring system was used to evaluate the extent and severity of sinusitis. The scale ranges from 0 (best possible outcome with complete lucency of all sinuses) to 24 (worst possible outcome with complete opacification of all sinuses)

Interventions

  • DRUG Placebo
  • DRUG Pulmozyme (dornase alfa)

Study Locations (1)

Vermont

  • Fletcher Allen Health Care - Burlington

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2006-12
Est. Completion 2012-06
Phase Phase 2
University of Vermont

162 total trials

What the finished NCT00416182 record still lists

NCT00416182 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (91% lower).

The record links to 2 conditions, with Cystic Fibrosis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT00416182 reports a single indexed study location in Vermont.

Frequently Asked Questions

What is clinical trial NCT00416182 about?

NCT00416182 is a clinical study titled "Nasally Delivered Pulmozyme for Sinusitis in Cystic Fibrosis". 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.

What is the current status of trial NCT00416182?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2006-12. Estimated completion is 2012-06.

What conditions does trial NCT00416182 study?

This clinical trial studies the following conditions: Cystic Fibrosis, Sinusitis.

What interventions are being tested in trial NCT00416182?

The interventions under investigation include: Placebo (DRUG), Pulmozyme (dornase alfa) (DRUG).

Who is sponsoring clinical trial NCT00416182?

This trial is sponsored by University of Vermont, which has 162 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00416182 being conducted?

This trial has 1 study location across Vermont. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Cystic Fibrosis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00416182's enrollment target sits among peer trials

16 140th of 169 higher than 26 of 169 other Cystic Fibrosis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Cystic Fibrosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00416182, the US trial registry maintained by the National Library of Medicine. NCT00416182 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.