A Study of the Comparable Efficacy and Safety of Pulmozyme (Dornase Alfa) Delivered by the eFlow Rapid Nebulizer System in Patients With Cystic Fibrosis - Full Text View

Purpose

This phase IV, multicenter, randomized, open-label, two-period crossover study will evaluate the comparable efficacy and safety of Pulmozyme (dornase alfa) delivered by the eRapid nebulizer system in patients with cystic fibrosis. Patients who have been receiving Pulmozyme once daily chronically for at least 6 months will continue to receive Pulmozyme once daily for a run-in period of 2 weeks using the Pari LC Plus nebulizer. Patients will then be randomized to receive in a crossover design Pulmozyme once daily for two treatment periods of 2 weeks each using either the Pari LC Plus or the eRapid nebulizer. Anticipated time on study treatment is 6 weeks.

Condition	Intervention	Phase
Cystic Fibrosis	Drug: dornase alfa [Pulmozyme]	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase IV Multicenter, Randomized, Open Label, Two-Period, Crossover Study in Patients With Cystic Fibrosis to Evaluate the Comparable Efficacy and Safety of Pulmozyme Delivered by the eFlow Rapid Nebulizer System

Resource links provided by NLM:

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis

Drug Information available for: Dornase alfa

U.S. FDA Resources

Further study details as provided by Genentech:

Primary Outcome Measures:

Stability of lung function: Percent predicted FEV1 at the end of each 2-week treatment period [ Time Frame: approximately 6 weeks ] [ Designated as safety issue: No ]
Safety: Incidence of adverse events [ Time Frame: approximately 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	November 2012
Estimated Study Completion Date:	August 2013
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: eRapid	Drug: dornase alfa [Pulmozyme] once daily by Pari eRapid nebulizer
Active Comparator: Jet Nebulizer	Drug: dornase alfa [Pulmozyme] once daily by Pari LC Plus jet nebulizer

Eligibility

Ages Eligible for Study:	6 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male and female patients, >/= 6 years of age
Confirmed diagnosis of cystic fibrosis (CF)
Receiving Pulmozyme once daily chronically for treatment of CF for at least 6 months prior to screening
Percent predicted FEV1 >/= 40% at screening based on the Wang (males < 18 years, females < 16 years) or Hankinson (males >/= 18 years, females >/= 16 years) standardized equations
Able to reproducibly perform spirometry testing and comply with study assessments

Exclusion Criteria:

An acute respiratory infection or pulmonary exacerbation within 4 weeks prior to randomization
Initiation of any new chronic therapy (e.g. inhaled corticosteroids, inhaled oral antibiotics, high-dose ibuprofen, hypertonic saline, ivacaftor) for respiratory disease within 4 weeks prior to randomization
Changes in chest physiotherapy schedule within 4 weeks prior to randomization
Hospitalization within 4 weeks prior to randomization
Planned hospitalization during the 6-week study
History of organ transplantation
Participation in an investigational drug or device study within 30 day prior to screening

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01712334

Contacts

Contact: Please reference Study ID Number: ML28249 www.roche.com/about_roche/roche_worldwide.htm

888-662-6728 (U.S. Only)

genentechclinicaltrials@druginfo.com

Locations

United States, Arizona
	Not yet recruiting
Phoenix, Arizona, United States, 85016
United States, Arkansas
	Recruiting
Little Rock, Arkansas, United States, 72202-3500
United States, Maine
	Not yet recruiting
Portland, Maine, United States, 04102
United States, Massachusetts
	Not yet recruiting
Boston, Massachusetts, United States, 02115
United States, New Hampshire
	Not yet recruiting
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
	Not yet recruiting
Long Branch, New Jersey, United States, 07740
United States, New York
	Not yet recruiting
Albany, New York, United States, 12208
	Not yet recruiting
Rochester, New York, United States, 14642
United States, North Carolina
	Not yet recruiting
Durham, North Carolina, United States, 27710
United States, Ohio
	Not yet recruiting
Akron, Ohio, United States, 43308-1062
	Not yet recruiting
Cincinnati, Ohio, United States, 45229
	Not yet recruiting
Cleveland, Ohio, United States, 44106
United States, South Carolina
	Recruiting
Washington, South Carolina, United States, 29406
United States, South Dakota
	Recruiting
Sioux Falls, South Dakota, United States, 57117
United States, Tennessee
	Recruiting
Nashville, Tennessee, United States, 37232-9119
United States, Texas
	Not yet recruiting
Houston, Texas, United States, 77030
United States, Utah
	Not yet recruiting
Salt Lake City, Utah, United States, 84132
United States, Washington
	Not yet recruiting
Seattle, Washington, United States, 98101

Sponsors and Collaborators

Genentech

Investigators

Study Director:

Clinical Trials

Genentech

More Information

No publications provided

Responsible Party:	Genentech
ClinicalTrials.gov Identifier:	NCT01712334 History of Changes
Other Study ID Numbers:	ML28249
Study First Received:	October 19, 2012
Last Updated:	January 11, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases

Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013