A Phase 2 interventional study of Pulmozyme (dornase alfa) and Placebo in Sinusitis and Cystic Fibrosis, sponsored by University of Vermont. Completed at 1 site in United States. Open to participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2014-11-14.
Sponsored by University of Vermont · Phase 2, Interventional, and Treatment
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.
AIM: To evaluate the effectiveness of Pulmozyme(dornase alfa) in decreasing post-operative sinusitis symptoms in patients with cystic fibrosis (CF)
PROCEDURES: 20 patients with CF will be randomized to receive either Pulmozyme or placebo via nasal inhalation daily for 12 months. Consent will be obtained following surgery and treatment will begin 1 week post-operatively.
Monitoring will include examination and recording of adverse effects and follow up weekly for one month and then at 2.5, 6, 9 and 12 months.
Outcome measures will include ciliary function testing, pulmonary function testing, sinus questionnaires and CT scan.
415 studies on the registry are indexed under Sinusitis; 46 are open to participants now.
This study's enrollment of 16 is below the median of 60 across 313 interventional studies indexed under Sinusitis.
Browse Sinusitis studies →University of Vermont is the lead sponsor of 215 studies on the registry; 28 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 9 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
2.5 mg Pulmozyme (dornase alfa) delivered intranasally once daily
Drug: Pulmozyme (dornase alfa)
2.5 mg/2mL placebo administered intranasally once daily
Drug: Placebo
2.5 mg/2.5 mL of Pulmozyme (dornase alfa) delivered via Sinustar nasal nebulizer device
Also known as: Pulmozyme, dornase alfa, human recombinant DNase 1
2.5 mL of placebo delivered via Sinustar nebulizer device
Also known as: placebo comparator
Computed Tomography Evidence of Less Sinus Disease
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)
Time frame: baseline and 1 year
Improvement in Appearance of Nasal Passages/Sinuses
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)
Time frame: baseline and 1 year
Chronic Sinusitis Survey Score
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.
Time frame: baseline and 1 year
Pulmonary Function
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.
Time frame: baseline and 1 year
Patients undergoing sinus surgery meeting inclusion criteria were approached in the outpatient or hospital setting
| Milestone | Pulmozyme (Dornase Alfa) | Placebo |
|---|---|---|
| Started | 8 | 8 |
| Completed | 5 | 6 |
| Not completed | 3 | 2 |
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)
| units on a scale | Pulmozyme | Placebo |
|---|---|---|
| Computed Tomography Evidence of Less Sinus Disease | 5.875 (-0.436 to 12.19) | 3 (0.055 to 5.945) |
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)
| units | Pulmozyme | Placebo |
|---|---|---|
| Improvement in Appearance of Nasal Passages/Sinuses | 0.2 (-0.84 to 1.24) | -1 (-2.24 to 0.24) |
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.
| units on a scale | Pulmozyme | Placebo |
|---|---|---|
| Chronic Sinusitis Survey Score | 8.5 (5.45 to 11.55) | 3 (-1.92 to 7.92) |
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.
| percentage of predicted FEV1 | Pulmozyme | Placebo |
|---|---|---|
| Pulmonary Function | 0.8 (-20 to 17) | 5.4 (-3 to 18) |
Collected over 1 year (study period). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pulmozyme | — | 1/8 (12.5%) | 1/8 (12.5%) |
| Placebo | — | 2/8 (25%) | 0/8 (0%) |
| Event | Pulmozyme | Placebo |
|---|---|---|
| hospitalization for pulmonary exacerbationRespiratory, thoracic and mediastinal disorders | 1/8 | 2/8 |
| Event | Pulmozyme | Placebo |
|---|---|---|
| sinus surgeryRespiratory, thoracic and mediastinal disorders | 1/8 | 0/8 |
| Age, Categorical(Participants) | Pulmozyme (Dornase Alfa) | Placebo | Total |
|---|---|---|---|
| <=18 years | 3 | 6 | 9 |
| Between 18 and 65 years | 5 | 2 | 7 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Pulmozyme (Dornase Alfa) | Placebo | Total |
|---|---|---|---|
| Female | 5 | 5 | 10 |
| Male | 3 | 3 | 6 |
| Region of Enrollment(participants) | Pulmozyme (Dornase Alfa) | Placebo | Total |
|---|---|---|---|
| United States | 8 | 8 | 16 |
This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
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University of Vermont