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Pulmozyme in Cystic Fibrosis With Sinusitis

NCT01155752 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2017-07-21

No results posted yet for this study

Summary

The hypothesis is that the intranasal use of Pulmozyme will decrease the severity of sinusitis in Cystic Fibrosis and lead to an improved quality of life.

Conditions

Interventions

DRUG

Pulmozyme single use ampule

• Each Pulmozyme single use ampule delivers 2.5 mL (2.5 mg) of the sterile solution to the nebulizer bowl. The aqueous solution contains 1.0 mg/mL dornase alfa, 0.15 mg/mL calcium chloride dihydrate, and 8.77 mg/mL sodium chloride.

DRUG

placebo

identical placebo

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • Milton S. Hershey Medical Center

    lead OTHER

Principal Investigators

  • Timothy Craig, DO · Penn State University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
12 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2014-06-30
Completion
2015-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01155752 on ClinicalTrials.gov