Trial · NCT00416182
Nasally Delivered Pulmozyme for Sinusitis in Cystic Fibrosis
NCT00416182, Phase 2, Completed, University of Vermont; results first posted 2014-11-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Nasally Delivered Pulmozyme for Sinusitis in Cystic Fibrosis. Trials, record NCT00416182. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00416182
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Nasally Delivered Pulmozyme for Sinusitis in Cystic Fibrosis
- NCT number
- NCT00416182
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 16 participants, actual
- Lead sponsor
- University of Vermont
- Conditions
- Sinusitis, Cystic Fibrosis
- Interventions
- Pulmozyme (dornase alfa), Placebo
- First posted
- 2006-12-27
- Last updated
- 2014-11-14
- Results first posted
- 2014-11-14
- Limitations and caveats
- recruitment for a long trial was difficult so enrollment was truncated.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Computed Tomography Evidence of Less Sinus Disease | baseline and 1 year | 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) |
| Primary | Improvement in Appearance of Nasal Passages/Sinuses | baseline and 1 year | periodic endoscopic photos of sinuses by ear-nose-throat (ENT) surgeon. The scale for scoring severity of disease ranges from 0 (best possible outcome) to 2 (worst possible outcome). independent blinded scoring by 2 surgeons difference in scores pre and post are reported (1 year minus baseline) |
| Secondary | Chronic Sinusitis Survey Score | baseline and 1 year | pre-surgery and end of trial (12 months) Reduction in scores (baseline minus 1 year) are recorded The chronic sinusitis survey consists of 6 questions, ranges from 0-24, a lower score indicates the best possible outcome. |
| Secondary | Pulmonary Function | baseline and 1 year | prior to surgery and end of study spirometry as measured by forced expiratory volume in 1 second (FEV1) percent predicted. The change over the course of the study (1 year minus baseline) is reported. A higher value indicates a better outcome. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Computed Tomography Evidence of Less Sinus Disease | baseline and 1 year | units on a scale | MEAN | |
| PRIMARY | Improvement in Appearance of Nasal Passages/Sinuses | baseline and 1 year | units | MEAN | |
| SECONDARY | Chronic Sinusitis Survey Score | baseline and 1 year | units on a scale | MEAN | |
| SECONDARY | Pulmonary Function | baseline and 1 year | percentage of predicted FEV1 | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Computed Tomography Evidence of Less Sinus Disease | Pulmozyme | 5.875 | 95% Confidence Interval -0.436 to 12.19 | units on a scale | |
| Computed Tomography Evidence of Less Sinus Disease | Placebo | 3 | 95% Confidence Interval 0.055 to 5.945 | units on a scale | |
| Improvement in Appearance of Nasal Passages/Sinuses | Pulmozyme | 0.2 | 95% Confidence Interval -0.84 to 1.24 | units | |
| Improvement in Appearance of Nasal Passages/Sinuses | Placebo | -1 | 95% Confidence Interval -2.24 to 0.24 | units | |
| Chronic Sinusitis Survey Score | Pulmozyme | 8.5 | 95% Confidence Interval 5.45 to 11.55 | units on a scale | |
| Chronic Sinusitis Survey Score | Placebo | 3 | 95% Confidence Interval -1.92 to 7.92 | units on a scale | |
| Pulmonary Function | Pulmozyme | 0.8 | Full Range -20 to 17 | percentage of predicted FEV1 | |
| Pulmonary Function | Placebo | 5.4 | Full Range -3 to 18 | percentage of predicted FEV1 |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pulmozyme (Dornase Alfa) | 8 | |
| Overall Study | STARTED | Placebo | 8 | |
| Overall Study | COMPLETED | Pulmozyme (Dornase Alfa) | 5 | |
| Overall Study | COMPLETED | Placebo | 6 | |
| Overall Study | NOT COMPLETED | Pulmozyme (Dornase Alfa) | 3 | |
| Overall Study | NOT COMPLETED | Placebo | 2 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | sinus surgery | Respiratory, thoracic and mediastinal disorders | Pulmozyme | 1 | 8 | 1 |
| other | sinus surgery | Respiratory, thoracic and mediastinal disorders | Placebo | 0 | 8 | 0 |
| serious | hospitalization for pulmonary exacerbation | Respiratory, thoracic and mediastinal disorders | Pulmozyme | 1 | 8 | 1 |
| serious | hospitalization for pulmonary exacerbation | Respiratory, thoracic and mediastinal disorders | Placebo | 2 | 8 | 2 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pulmozyme | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Pulmozyme | 1 | 8 |
| Total, other adverse events | Placebo | 0 | 8 |
| Total, serious adverse events | Pulmozyme | 1 | 8 |
| Total, serious adverse events | Placebo | 2 | 8 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33735508 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Pulmozyme vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00416182
GET https://conductscience.org/api/trials/v1/NCT00416182/registered