A Study of Pulmozyme® (Dornase Alpha) in 3- to 5-Year-Old Patients With Cystic Fibrosis - Full Text View

Sponsored by:	Genentech
Information provided by:	Genentech
ClinicalTrials.gov Identifier:	NCT00680316

Purpose

This is a Phase IV, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the effect of Pulmozyme on pulmonary function, HRQOL, and respiratory symptoms in 3- to 5-year-old children with CF. After assessing their ability to participate, approximately 40 children will have baseline assessments before being randomized at approximately 5-8 sites across the United States. Children will receive approximately 16 days of study treatment.

Condition	Intervention	Phase
Cystic Fibrosis	Drug: dornase alfa Drug: placebo	Phase IV

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis

Drug Information available for: Dornase alfa

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment
Official Title:	A Phase IV, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Pulmozyme® in 3- to 5-Year-Old Patients With Cystic Fibrosis

Further study details as provided by Genentech:

Primary Outcome Measures:

Change in pulmonary function as measured by oscillometry [ Time Frame: From Visit 2 to Visit 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in pulmonary function as measured by oscillometry and spirometry [ Time Frame: From Vist 2 to Visit 3 ] [ Designated as safety issue: No ]
Change in quality of life and disease specific symptoms [ Time Frame: From Vist 2 to Visit 3 ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	June 2008
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: dornase alfa Nebulized repeat dose
2: Placebo Comparator	Drug: placebo Nebulized repeat dose

Eligibility

Ages Eligible for Study:	3 Years to 5 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Signed Informed Consent Form
Aged 3-5 years
Diagnosis of cystic fibrosis

Exclusion Criteria:

Children taking scheduled inhaled Pulmozyme or hypertonic saline within 56 days prior to Visit 1 or any Pulmozyme in the 28 days before Visit 1
Involvement in a clinical intervention trial within the 4 weeks prior to Visit 1
Use of an investigational drug or device within 28 days prior to Visit 1
Any other condition that might increase the risk of participation to the patient in the judgement of the investigator

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00680316

Locations

United States, Colorado
Childrens Hospital-Denver	Recruiting
Aurora, Colorado, United States, 80045
Contact: Churee Pardee 720-777-6162 pardee.churee@tchden.org
United States, Illinois
Childrens Memorial Hosp	Recruiting
Chicago, Illinois, United States, 60614
Contact: Janine Judge 773-880-4000 jjudge@childrensmemorial.org
United States, Michigan
Univ of Michigan Medical Healt	Recruiting
Ann Arbor, Michigan, United States, 48109-5212
Contact: Marisa Linn 734-615-1372 mlinn@umich.edu
United States, New York
University of Rochester	Recruiting
Rochester, New York, United States, 14642
Contact: Marissa Dixon 585-275-8580 marissa_dixon@urmc.rochester.edu
United States, North Carolina
University of North Carolina	Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Caroline O'Connor 919-843-7121 coconnor@med.unc.edu
United States, Ohio
Rainbow Babies & Child Hosp	Recruiting
Cleveland, Ohio, United States, 44106
Contact: Bobbi Ksenich 216-844-5733 Roberta.Ksenich@UHHospitals.org
United States, Pennsylvania
Children's Hosp Philadelphia	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Sarajane Wilson 267-426-7161 WILSONS1@email.chop.edu
United States, Washington
Children's Hosp & Reg Med Ctr	Recruiting
Seattle, Washington, United States, 98105
Contact: Alan Genatossio 206-987-3317 alan.genatossio@seattlechildrens.org

Sponsors and Collaborators

Genentech

Investigators

Study Director:

Michelle Freemer, M.D.

Genentech

More Information

No publications provided

Responsible Party:	Genentech, Inc. ( Clinical Trials Posting Group )
Study ID Numbers:	Z4240g
Study First Received:	May 16, 2008
Last Updated:	February 10, 2009
ClinicalTrials.gov Identifier:	NCT00680316 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genentech:

Pulmozyme
CF

Study placed in the following topic categories:

Digestive System Diseases
Genetic Diseases, Inborn
Respiratory Tract Diseases
Cystic Fibrosis

Fibrosis
Lung Diseases
Infant, Newborn, Diseases
Pancreatic Diseases

Additional relevant MeSH terms:

Pathologic Processes
Digestive System Diseases
Genetic Diseases, Inborn
Respiratory Tract Diseases
Cystic Fibrosis

Fibrosis
Lung Diseases
Infant, Newborn, Diseases
Pancreatic Diseases

ClinicalTrials.gov processed this record on May 07, 2009