Nasally Delivered Pulmozyme for Sinusitis in Cystic Fibrosis



Status:Archived
Conditions:Sinusitis, Pulmonary
Therapuetic Areas:Otolaryngology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any
Updated:7/1/2011

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The Use of Nasally Delivered Pulmozyme in the Treatment of Sinusitis in Cystic Fibrosis Patients: A Pilot Study


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

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.


We found this trial at
1
site
111 Colchester Ave
Burlington, Vermont 05401
(802) 847-0000
Fletcher Allen Health Care As Vermont’s University Medical Center, we at Fletcher Allen are committed...
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Burlington, VT
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