<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/NCT01676987</url>
  </required_header>
  <id_info>
    <org_study_id>Ach-ALN-04(7/07)</org_study_id>
    <nct_id>NCT01676987</nct_id>
  </id_info>
  <brief_title>Evaluation of the Efficacy and Safety of a Fixed-dose, Single-capsule Budesonide-formoterol Combination in Uncontrolled Asthma</brief_title>
  <acronym>Ach-ALN</acronym>
  <official_title>Evaluation of the Efficacy and Safety of a Fixed-dose, Single-capsule Budesonide-formoterol Combination in Uncontrolled Asthma:a Randomized, Double-blind, Multicenter, Controlled Clinical Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ache Laboratorios Farmaceuticos S.A.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ache Laboratorios Farmaceuticos S.A.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the efficacy and safety of a fixed-dose, single-capsule&#xD;
      budesonide(400µg)-formoterol(12µg) combination, in comparison with budesonide alone, both&#xD;
      delivered via a dry powder inhaler, in 181 patients with uncontrolled asthma.This was&#xD;
      Randomized, double-blind, multicenter, phase III, parallel clinical trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      the age of the patients ranged from 18 to 77 years. After a run-in period of 4 weeks, during&#xD;
      which all of the patients received budesonide twice a day, they were randomized into one of&#xD;
      the treatment groups for 12 weeks, twice a day.&#xD;
&#xD;
      The primary outcome measures were FEV1, FVC and morning PEF. We performed an&#xD;
      intention-to-treat analysis of the data.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2009</start_date>
  <completion_date type="Actual">June 2011</completion_date>
  <primary_completion_date type="Actual">September 2010</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of the efficacy and safety of a fixed-dose, single capsule budesonide-formoterol combination in comparison with budesonide alone in patients with uncontrolled asthma</measure>
    <time_frame>12 weeks</time_frame>
    <description>the primary outcome Measures were FEV1(forced expiratory volume in one second), FVC(forced vital capacity)and morning PEF (peak expiratory flow).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">181</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Fixed Combination of Budesonide and formoterol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group 1 (experimental): Fixed Combination of Budesonide and formoterol</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Budesonide</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group 2 (comparator): Budesonide</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fixed combination of budesonide and formoterol</intervention_name>
    <description>Delivered dry powder inhaler for 12 weeks.</description>
    <arm_group_label>Fixed Combination of Budesonide and formoterol</arm_group_label>
    <other_name>Group 1 (experimental): Budesonide and formoterol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Budesonide</intervention_name>
    <description>Delivered dry powder inhaler for 12 weeks.</description>
    <arm_group_label>Budesonide</arm_group_label>
    <other_name>Group 2 (comparator): Budesonide</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of uncontrolled asthma&#xD;
&#xD;
          -  Age ranged from 18 to 77 years&#xD;
&#xD;
          -  Nonsmokers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of oral corticosteroids, anti-leukotrienes, immunoglobulins, beta blockers,&#xD;
             digitalis, amiodarone, antifungals, antidepressants, monoamine oxidase inhibitors and&#xD;
             tricyclics during the standardization&#xD;
&#xD;
          -  Atrial fibrillation, Flutter, severe and complex tachyarrhythmias atrioventricular&#xD;
             block 1,2 and 3&#xD;
&#xD;
          -  Diabetes mellitus&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Neuropsychiatric diseases&#xD;
&#xD;
          -  Pulmonary malformations, tuberculosis, Cystic fibrosis&#xD;
&#xD;
          -  Immunosuppressive treatment&#xD;
&#xD;
          -  Hospitalization for asthma or respiratory infection in last 30 days&#xD;
&#xD;
          -  Severe systemic disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>77 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Emílio Pizzichini</last_name>
    <role>Principal Investigator</role>
    <affiliation>NUPAIVA Asthma Research Center, UFSC- Brazil</affiliation>
  </overall_official>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 29, 2012</study_first_submitted>
  <study_first_submitted_qc>August 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 31, 2012</study_first_posted>
  <last_update_submitted>August 30, 2012</last_update_submitted>
  <last_update_submitted_qc>August 30, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 31, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Asthma</keyword>
  <keyword>Budesonide</keyword>
  <keyword>Adrenergic beta-2 receptor agonists.</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Budesonide</mesh_term>
    <mesh_term>Formoterol Fumarate</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>October 25, 2016</submitted>
    <returned>December 16, 2016</returned>
    <submitted>January 3, 2017</submitted>
    <submission_canceled>Unknown</submission_canceled>
    <submitted>January 4, 2017</submitted>
    <returned>February 22, 2017</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT01676987
org study id: Ach-ALN-04(7/07)
nct id: NCT01676987
lead sponsor: 
has dmc: Yes
To evaluate the efficacy and safety of a fixed-dose, single-capsule
      budesonide(400µg)-formoterol(12µg) combination, in comparison with budesonide alone, both
      delivered via a dry powder inhaler, in 181 patients with uncontrolled asthma.This was
      Randomized, double-blind, multicenter, phase III, parallel clinical trial.
the age of the patients ranged from 18 to 77 years. After a run-in period of 4 weeks, during
      which all of the patients received budesonide twice a day, they were randomized into one of
      the treatment groups for 12 weeks, twice a day.

      The primary outcome measures were FEV1, FVC and morning PEF. We performed an
      intention-to-treat analysis of the data.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Evaluation of the efficacy and safety of a fixed-dose, single capsule budesonide-formoterol combination in comparison with budesonide alone in patients with uncontrolled asthma
time frame: 12 weeks
description: the primary outcome Measures were FEV1(forced expiratory volume in one second), FVC(forced vital capacity)and morning PEF (peak expiratory flow).
arm group label: Fixed Combination of Budesonide and formoterol
arm group type: Experimental
description: Group 1 (experimental): Fixed Combination of Budesonide and formoterol
arm group label: Budesonide
arm group type: Active Comparator
description: Group 2 (comparator): Budesonide
intervention type: Drug
intervention name: Fixed combination of budesonide and formoterol
description: Delivered dry powder inhaler for 12 weeks.
arm group label: Fixed Combination of Budesonide and formoterol
other name: Group 1 (experimental): Budesonide and formoterol
intervention type: Drug
intervention name: Budesonide
description: Delivered dry powder inhaler for 12 weeks.
arm group label: Budesonide
other name: Group 2 (comparator): Budesonide
criteria: 
gender: All
minimum age: 18 Years
maximum age: 77 Years
healthy volunteers: No
last name: Emílio Pizzichini
role: Principal Investigator
affiliation: NUPAIVA Asthma Research Center, UFSC- Brazil
responsible party type: Sponsor
mesh term: Asthma
mesh term: Budesonide
mesh term: Formoterol Fumarate
submitted: October 25, 2016
returned: December 16, 2016
submitted: January 3, 2017
submission canceled: Unknown
submitted: January 4, 2017
returned: February 22, 2017