Nasally Delivered Pulmozyme for Sinusitis in Cystic Fibrosis

Completed · Phase 2 · Has a placebo group

Conditions studied: Sinusitis, Cystic Fibrosis

In brief

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.

Key facts

Study ID

NCT00416182

Run by

University of Vermont

People needed

16

Starts

2006-12-01

Expected to finish

2012-06-01

Last updated by the study team

2014-11-14

Who can join

Age: 5 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical and laboratory diagnosis of cystic fibrosis
• Age greater than or equal to 5 years
• Forced expiratory volume in 1 second (FEV1) greater than or equal to 40% predicted
• Sinus surgery within one week of enrollment

You may not qualify if…

• Pregnancy
• Intolerance of orally inhaled Pulmozyme (dornase alfa)

Where it is running

• Fletcher Allen Health Care — Burlington, Vermont, United States

Full record on ClinicalTrials.gov

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