Phase 2 Cystic Fibrosis Trial, Completed NCT00416182 Sponsor: University of Vermont Condition: Cystic Fibrosis
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial enrolled 16 people in total — 8 received a drug called Pulmozyme (also known as dornase alfa) and 8 received a placebo (a dummy treatment with no active ingredient). The trial was looking at whether Pulmozyme, delivered directly into the sinuses after surgery, could reduce sinus disease in people with cystic fibrosis over a 12-month period. Not everyone finished the study: 5 people in the Pulmozyme group and 6 in the placebo group completed it, with 3 and 2 people respectively not completing the trial (the reasons were not detailed in the reported data). The reported data shows the following numbers across the main and secondary measurements. For sinus appearance on CT scans (scored on a 0–24 scale, where a higher number means more disease), the Pulmozyme group's score changed by 5.875 units and the placebo group's score changed by 3 units — both representing a reduction from baseline, meaning less disease was seen at one year in both groups. For the appearance of the nasal passages as assessed by a surgeon using a camera (scored 0–2, where lower is better), the Pulmozyme group's score changed by +0.2 units and the placebo group's score changed by −1 unit from baseline. On a sinusitis symptom survey (scored 0–24, where lower is better), the Pulmozyme group's score reduced by 8.5 units and the placebo group's by 3 units. For lung function — measured as how much air a person can forcefully breathe out in one second — the reported change over the year was +0.8 percentage points for the Pulmozyme group and +5.4 percentage points for the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 2 Cystic Fibrosis Trial, Completed

NCT00416182
Completed Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been diagnosed with cystic fibrosis through medical tests and lab results
  • You are 5 years old or older
  • Your lung function test shows that you can breathe out at least 40% of the normal expected amount in one second (confirm with trial site)
  • You have had sinus surgery within one week of joining the trial

Who may not be able to join:

  • You are pregnant
  • You have had a bad reaction to or cannot tolerate a inhaled medication called Pulmozyme (also known as dornase alfa)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

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Trial details

Status
Completed
Phase
Phase 2
Sponsor
University of Vermont
Registry
ClinicalTrials.gov
Start date
1 December 2006
Est. completion
1 June 2012

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Computed Tomography Evidence of Less Sinus Disease; Improvement in Appearance of Nasal Passages/Sinuses

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov