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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01712334
First received: October 19, 2012
Last updated: January 6, 2014
Last verified: January 2014
  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:


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 ]

Enrollment: 87
Study Start Date: December 2012
Study Completion Date: June 2013
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

Locations
United States, Arizona
Phoenix, Arizona, United States, 85016
United States, Arkansas
Little Rock, Arkansas, United States, 72202
United States, Maine
Portland, Maine, United States, 4102
United States, Massachusetts
Boston, Massachusetts, United States, 02115
United States, New Hampshire
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Long Branch, New Jersey, United States, 07740
United States, New York
Rochester, New York, United States, 14618
United States, North Carolina
Durham, North Carolina, United States, 27710
United States, Ohio
Akron, Ohio, United States, 44308
Cleveland, Ohio, United States, 44106
United States, South Carolina
Charleston, South Carolina, United States, 29425
United States, South Dakota
Sioux Falls, South Dakota, United States, 57104
United States, Tennessee
Nashville, Tennessee, United States, 37232-9119
United States, Texas
Houston, Texas, United States, 77030
United States, Utah
Salt Lake City, Utah, United States, 84132
United States, Washington
Seattle, Washington, United States, 98105
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 6, 2014
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 April 17, 2014