<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01712334</url>
  </required_header>
  <id_info>
    <org_study_id>ML28249</org_study_id>
    <nct_id>NCT01712334</nct_id>
  </id_info>
  <brief_title>A Study of the Comparable Efficacy and Safety of Pulmozyme (Dornase Alfa) Delivered by the eRapid Nebulizer System in Patients With Cystic Fibrosis</brief_title>
  <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 eRapid Nebulizer System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Genentech, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Genentech, Inc.</source>
  <brief_summary>
    <textblock>
      This phase IV, multicenter, randomized, open-label, two-period crossover study will evaluate&#xD;
      the comparable efficacy and safety of Pulmozyme (dornase alfa) delivered by the eRapid&#xD;
      nebulizer system in patients with cystic fibrosis. Patients who have been receiving Pulmozyme&#xD;
      once daily chronically for at least 6 months will continue to receive Pulmozyme once daily&#xD;
      for a run-in period of 2 weeks using the Pari LC Plus nebulizer. Patients will then be&#xD;
      randomized to receive in a crossover design Pulmozyme once daily for two treatment periods of&#xD;
      2 weeks each using either the Pari LC Plus or the eRapid nebulizer. Anticipated time on study&#xD;
      treatment is 6 weeks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">June 2013</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Stability of Lung Function: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1)</measure>
    <time_frame>At the end of each 2-week treatment period</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety: Number of Participants With Adverse Events During Each Treatment Period</measure>
    <time_frame>4 Weeks</time_frame>
    <description>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.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">99</enrollment>
  <condition>Cystic Fibrosis</condition>
  <arm_group>
    <arm_group_label>eRapid Nebulizer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dornase alfa (Pulmozyme®) inhaled once daily by the Pari eRapid nebulizer for 2 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Jet Nebulizer</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Dornase alfa (Pulmozyme®) inhaled once daily by the Pari LC Plus jet nebulizer for 2 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>dornase alfa [Pulmozyme®]</intervention_name>
    <description>Inhaled once daily by Pari eRapid nebulizer.</description>
    <arm_group_label>eRapid Nebulizer</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>dornase alfa [Pulmozyme®]</intervention_name>
    <description>Inhaled once daily by Pari LC Plus jet nebulizer.</description>
    <arm_group_label>Jet Nebulizer</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female patients, &gt;/= 6 years of age&#xD;
&#xD;
          -  Confirmed diagnosis of cystic fibrosis (CF)&#xD;
&#xD;
          -  Receiving Pulmozyme once daily chronically for treatment of CF for at least 6 months&#xD;
             prior to screening&#xD;
&#xD;
          -  Percent predicted FEV1 &gt;/= 40% at screening based on the Wang (males &lt; 18 years,&#xD;
             females &lt; 16 years) or Hankinson (males &gt;/= 18 years, females &gt;/= 16 years)&#xD;
             standardized equations&#xD;
&#xD;
          -  Able to reproducibly perform spirometry testing and comply with study assessments&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  An acute respiratory infection or pulmonary exacerbation within 4 weeks prior to&#xD;
             randomization&#xD;
&#xD;
          -  Initiation of any new chronic therapy (e.g. inhaled corticosteroids, inhaled oral&#xD;
             antibiotics, high-dose ibuprofen, hypertonic saline, ivacaftor) for respiratory&#xD;
             disease within 4 weeks prior to randomization&#xD;
&#xD;
          -  Changes in chest physiotherapy schedule within 4 weeks prior to randomization&#xD;
&#xD;
          -  Hospitalization within 4 weeks prior to randomization&#xD;
&#xD;
          -  Planned hospitalization during the 6-week study&#xD;
&#xD;
          -  History of organ transplantation&#xD;
&#xD;
          -  Participation in an investigational drug or device study within 30 day prior to&#xD;
             screening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>Genentech, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Portland</city>
        <state>Maine</state>
        <zip>4102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Long Branch</city>
        <state>New Jersey</state>
        <zip>07740</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14618</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Akron</city>
        <state>Ohio</state>
        <zip>44308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sioux Falls</city>
        <state>South Dakota</state>
        <zip>57104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232-9119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2014</verification_date>
  <study_first_submitted>October 19, 2012</study_first_submitted>
  <study_first_submitted_qc>October 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 23, 2012</study_first_posted>
  <results_first_submitted>March 27, 2014</results_first_submitted>
  <results_first_submitted_qc>March 31, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">May 1, 2014</results_first_posted>
  <last_update_submitted>March 31, 2014</last_update_submitted>
  <last_update_submitted_qc>March 31, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 1, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cystic Fibrosis</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>99 patients were enrolled. 96 unique patients entered the run-in period including 3 patients who entered the run-in period twice.</recruitment_details>
      <pre_assignment_details>Patients received dornase alfa (Pulmozyme®) by LC Plus nebulizer in the 2-week run-in period prior to randomization. A total of 86 unique patients were randomized in the study in 87 randomization events. Of the randomized patients, 85 patients completed the study in two treatment sequences.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>eRapid Nebulizer Then Jet Nebulizer</title>
          <description>Dornase alfa (Pulmozyme®) inhaled once daily by the Pari eRapid nebulizer for 2 weeks in Treatment Period 1 then Pulmozyme® inhaled once daily by the Pari LC Plus jet nebulizer for 2 weeks in Treatment Period 2.&#xD;
.</description>
        </group>
        <group group_id="P2">
          <title>Jet Nebulizer Then eRapid Nebulizer</title>
          <description>Pulmozyme® inhaled once daily by the Pari LC Plus jet nebulizer for 2 weeks in Treatment Period 1 then Pulmozyme® inhaled once daily by the Pari eRapid nebulizer for 2 weeks in Treatment Period 2.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Treatment Period 1</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="44"/>
                <participants group_id="P2" count="43"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received Treatment</title>
              <participants_list>
                <participants group_id="P1" count="44"/>
                <participants group_id="P2" count="41"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="44"/>
                <participants group_id="P2" count="41"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Randomized in Error</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Treatment Period 2</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="44"/>
                <participants group_id="P2" count="41"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="44"/>
                <participants group_id="P2" count="41"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Baseline measures were based on the modified Intent-to-Treat (mITT) population that included all participants randomized with both baseline and endpoint Forced Expiratory Volume in 1 second (FEV1) values for both treatment periods.</population>
      <group_list>
        <group group_id="B1">
          <title>All Participants</title>
          <description>All participants received dornase alfa (Pulmozyme) inhaled once daily by the Pari eRapid nebulizer or the Pari LC Plus jet nebulizer for 2 weeks in Treatment Period 1 then crossed over to use the other nebulizer in Treatment Period 2 for 2 weeks.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="85"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13.6" spread="6.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Stability of Lung Function: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1)</title>
        <description>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.</description>
        <time_frame>At the end of each 2-week treatment period</time_frame>
        <population>Modified Intent-to-Treat (mITT) population included all randomized participants with baseline and endpoint FEV1 values for both treatment periods.</population>
        <group_list>
          <group group_id="O1">
            <title>eRapid Nebulizer</title>
            <description>Dornase alfa (Pulmozyme®) inhaled once daily by the Pari eRapid nebulizer for 2 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Jet Nebulizer</title>
            <description>Pulmozyme® inhaled once daily by the Pari LC Plus jet nebulizer for 2 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Stability of Lung Function: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1)</title>
          <description>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.</description>
          <population>Modified Intent-to-Treat (mITT) population included all randomized participants with baseline and endpoint FEV1 values for both treatment periods.</population>
          <units>percent predicted</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="85"/>
                <count group_id="O2" value="85"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.1" spread="22.1"/>
                    <measurement group_id="O2" value="97.2" spread="20.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>The ratio of the mean percent predicted FEV1 at the end of the eRapid treatment to the mean percent predicted FEV1 at the end of the LC Plus jet nebulizer treatment. The two nebulizers were considered equivalent if the 90% CI was within 80%-125%.</non_inferiority_desc>
            <param_type>Ratio (Fieller's theorem)</param_type>
            <param_value>100.9</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>99.5</ci_lower_limit>
            <ci_upper_limit>102.3</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Safety: Number of Participants With Adverse Events During Each Treatment Period</title>
        <description>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.</description>
        <time_frame>4 Weeks</time_frame>
        <population>Safety population included all randomized participants who received treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>eRapid Nebulizer</title>
            <description>Dornase alfa (Pulmozyme®) inhaled once daily by the Pari eRapid nebulizer for 2 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Jet Nebulizer</title>
            <description>Pulmozyme® inhaled once daily by the Pari LC Plus jet nebulizer for 2 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Safety: Number of Participants With Adverse Events During Each Treatment Period</title>
          <description>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.</description>
          <population>Safety population included all randomized participants who received treatment.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="85"/>
                <count group_id="O2" value="85"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>Safety population included all randomized participants who received treatment.</desc>
      <group_list>
        <group group_id="E1">
          <title>eRapid Nebulizer</title>
          <description>Dornase alfa (Pulmozyme®) inhaled once daily by the Pari eRapid nebulizer for 2 weeks.</description>
        </group>
        <group group_id="E2">
          <title>Jet Nebulizer</title>
          <description>Pulmozyme® inhaled once daily by the Pari LC Plus jet nebulizer for 2 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Medical Communications</name_or_title>
      <organization>Hoffman-LaRoche</organization>
      <phone>800-821-8590</phone>
      <email>genentech@druginfo.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01712334
org study id: ML28249
nct id: NCT01712334
lead sponsor: 
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.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
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
description: 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.
measure: Safety: Number of Participants With Adverse Events During Each Treatment Period
time frame: 4 Weeks
description: 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.
arm group label: eRapid Nebulizer
arm group type: Experimental
description: Dornase alfa (Pulmozyme®) inhaled once daily by the Pari eRapid nebulizer for 2 weeks.
arm group label: Jet Nebulizer
arm group type: Active Comparator
description: Dornase alfa (Pulmozyme®) inhaled once daily by the Pari LC Plus jet nebulizer for 2 weeks.
intervention type: Drug
intervention name: dornase alfa [Pulmozyme®]
description: Inhaled once daily by Pari eRapid nebulizer.
arm group label: eRapid Nebulizer
intervention type: Drug
intervention name: dornase alfa [Pulmozyme®]
description: Inhaled once daily by Pari LC Plus jet nebulizer.
arm group label: Jet Nebulizer
criteria: 
gender: All
minimum age: 6 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Trials
role: Study Director
affiliation: Genentech, Inc.
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country: United States
responsible party type: Sponsor
mesh term: Cystic Fibrosis
mesh term: Fibrosis
participant flow: 
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outcome list: 
reported events: 
certain agreements: 
point of contact: 