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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01712334
First received: October 19, 2012
Last updated: March 31, 2014
Last verified: March 2014

October 19, 2012
March 31, 2014
December 2012
June 2013   (final data collection date for primary outcome measure)
  • Stability of Lung Function: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: At the end of each 2-week treatment period ] [ Designated as safety issue: No ]
    Spirometry was performed according to American Thoracic Society standards. FEV1 is the amount of air that is forced out of the lungs in one second and was measured at the end of each 2-week treatment period. The percent predicted FEV1 was calculated as: Percent predicted FEV1 =FEV1 (L) / Predicted FEV1 (L) ×100.
  • Safety: Number of Participants With Adverse Events During Each Treatment Period [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
    An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events.
  • 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 ]
Complete list of historical versions of study NCT01712334 on ClinicalTrials.gov Archive Site
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A Study of the Comparable Efficacy and Safety of Pulmozyme (Dornase Alfa) Delivered by the eRapid Nebulizer System in Patients With Cystic Fibrosis
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 eRapid Nebulizer System

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Cystic Fibrosis
  • Drug: dornase alfa [Pulmozyme®]
    Inhaled once daily by Pari eRapid nebulizer.
  • Drug: dornase alfa [Pulmozyme®]
    Inhaled once daily by Pari LC Plus jet nebulizer.
  • Experimental: eRapid Nebulizer
    Dornase alfa (Pulmozyme®) inhaled once daily by the Pari eRapid nebulizer for 2 weeks.
    Intervention: Drug: dornase alfa [Pulmozyme®]
  • Active Comparator: Jet Nebulizer
    Dornase alfa (Pulmozyme®) inhaled once daily by the Pari LC Plus jet nebulizer for 2 weeks.
    Intervention: Drug: dornase alfa [Pulmozyme®]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
99
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
6 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01712334
ML28249
Not Provided
Genentech, Inc.
Genentech, Inc.
Not Provided
Study Director: Clinical Trials Genentech, Inc.
Genentech, Inc.
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP