<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/NCT01715311</url>
  </required_header>
  <id_info>
    <org_study_id>CQAB149B2425</org_study_id>
    <secondary_id>2012-001536-59</secondary_id>
    <nct_id>NCT01715311</nct_id>
  </id_info>
  <brief_title>Comparison of Indacaterol With That of Placebo in 'Maintenance naïve' Patients With COPD Using Blinded Tiotropium as Active Control</brief_title>
  <acronym>INITIATE</acronym>
  <official_title>A Randomized, Double-blind Placebo-controlled Study to Compare the Efficacy of Indacaterol With That of Placebo in Patients With COPD Who Have Not Previously Received Maintenance COPD Medication, Using Blinded Tiotropium as Active Control</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novartis Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novartis</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will compare the efficacy of indacaterol versus placebo (i.e., rescue medication&#xD;
      only) and tiotropium in patients with Chronic Obstructive Pulmonary Disease (COPD) who have&#xD;
      not received maintenance COPD medication for at least 12 months prior to entry (described&#xD;
      hereafter as &quot;maintenance naïve&quot;, see inclusion criteria).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose is to provide efficacy data comparing the long-acting beta-2 agonist,&#xD;
      indacaterol, with short-acting rescue therapy in maintenance-naive patients belonging to GOLD&#xD;
      2011 Groups A and B.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    withdrawn prior to patient recruitment&#xD;
  </why_stopped>
  <start_date>November 2012</start_date>
  <completion_date type="Anticipated">September 2013</completion_date>
  <primary_completion_date type="Anticipated">September 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy comparison of indacaterol to placebo</measure>
    <time_frame>12 weeks</time_frame>
    <description>Efficacy comparison of indacaterol to placebo (once daily treatment) by measuring Trough Forced Expiratory Volume in one second 24 hour postdose after 12 weeks of treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>St George's Respiratory Questionnaire for COPD (SGRQ- C) total score comparison between treatments</measure>
    <time_frame>12 weeks</time_frame>
    <description>Effects comparison of indacaterol to placebo in terms of the patient-centric measurement St George's Respiratory Questionnaire for COPD (SGRQ- C) total score after 12 weeks of treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of Forced Expiratory Volume in one second between indacaterol and tiotropium groups</measure>
    <time_frame>12 weeks</time_frame>
    <description>Comparison of indacaterol to tiotropium using Trough Forced Expiratory Volume in one second.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>St George's Respiratory Questionnaire for COPD total score comparison between treatments</measure>
    <time_frame>12 weeks</time_frame>
    <description>Effects comparison of indacaterol to tiotropium in terms of St George's Respiratory Questionnaire for COPD (SGRQ- C) total score after 12 weeks of treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events and serious adverse events for all treatment groups</measure>
    <time_frame>week 12</time_frame>
    <description>All adverse events will be reported</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease (COPD)</condition>
  <arm_group>
    <arm_group_label>Indacaterol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Indacaterol once daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo for indacaterol and placebo for tiotropium once daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tiotropium</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Tiotropium</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Indacaterol</intervention_name>
    <description>Indacaterol once daily via single-dose dry powder inhaler</description>
    <arm_group_label>Indacaterol</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo to tiotropium</intervention_name>
    <description>Placebo to tiotropium capsules for inhalation once daily</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>Tiotropium</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tiotropium</intervention_name>
    <description>Tiotropium capsules for inhalation once daily</description>
    <arm_group_label>Tiotropium</arm_group_label>
    <other_name>Tiotropium 18 mcg od via single-dose dry powder inhaler</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo to indacaterol</intervention_name>
    <description>Placebo to indacaterol capsules for inhalation once daily</description>
    <arm_group_label>Indacaterol</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with stable Chronic Obstructive Pulmonary Disease (COPD) Groups A or B&#xD;
             according to GOLD 2011.&#xD;
&#xD;
          -  Patients with a post-bronchodilator Forced Expiratory Volume in one second (FEV1) ≥50%&#xD;
             and &lt;80% of the predicted normal, and post-bronchodilator FEV1/ Forced Vital Capacity&#xD;
             (FVC) &lt; 0.7&#xD;
&#xD;
          -  Patients with no record of receipt of maintenance medication for COPD.&#xD;
&#xD;
          -  Patients with a mMRC dyspnea score ≥1 at Visit 2.&#xD;
&#xD;
          -  Current or ex-smokers who have a smoking history of at least 10 pack years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have not achieved acceptable spirometry results at run-in, in accordance&#xD;
             with American Thoracic Society (ATS) / European Respiratory Society (ERS) criteria for&#xD;
             acceptability and repeatability.&#xD;
&#xD;
          -  Patients who have had 2 or more COPD exacerbations that required treatment with&#xD;
             antibiotics, systemic steroids (oral or intravenous) or hospitalization in the 12&#xD;
             months prior to Visit 1.&#xD;
&#xD;
          -  Patients who have had a respiratory tract infection.&#xD;
&#xD;
          -  Patients requiring long-term oxygen therapy (&gt;12 hours a day) on a daily basis.&#xD;
&#xD;
          -  Patients with a) any history of asthma, or b) onset of respiratory symptoms prior to&#xD;
             age 40 years.&#xD;
&#xD;
          -  Patients with allergic rhinitis who use a H1-antagonist or intra-nasal corticosteroids&#xD;
             intermittently. Treatment with a stable dose is permitted.&#xD;
&#xD;
          -  Patients with concomitant pulmonary disease (e.g., lung fibrosis, sarcoidosis,&#xD;
             interstitial lung disorder, pulmonary hypertension) or active pulmonary tuberculosis&#xD;
&#xD;
          -  Other protocol-defined inclusion/exclusion criteria may apply.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Novartis Pharmaceuticals</last_name>
    <role>Study Director</role>
    <affiliation>Novartis Pharmaceuticals</affiliation>
  </overall_official>
  <verification_date>February 2013</verification_date>
  <study_first_submitted>October 24, 2012</study_first_submitted>
  <study_first_submitted_qc>October 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 26, 2012</study_first_posted>
  <last_update_submitted>April 19, 2017</last_update_submitted>
  <last_update_submitted_qc>April 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COPD</keyword>
  <keyword>Chronic obstructive pulmonary disease</keyword>
  <keyword>indacaterol</keyword>
  <keyword>tiotropium</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tiotropium Bromide</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01715311
org study id: CQAB149B2425
secondary id: 2012-001536-59
nct id: NCT01715311
lead sponsor: 
has dmc: No
This study will compare the efficacy of indacaterol versus placebo (i.e., rescue medication
      only) and tiotropium in patients with Chronic Obstructive Pulmonary Disease (COPD) who have
      not received maintenance COPD medication for at least 12 months prior to entry (described
      hereafter as "maintenance naïve", see inclusion criteria).
The purpose is to provide efficacy data comparing the long-acting beta-2 agonist,
      indacaterol, with short-acting rescue therapy in maintenance-naive patients belonging to GOLD
      2011 Groups A and B.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Efficacy comparison of indacaterol to placebo
time frame: 12 weeks
description: Efficacy comparison of indacaterol to placebo (once daily treatment) by measuring Trough Forced Expiratory Volume in one second 24 hour postdose after 12 weeks of treatment.
measure: St George's Respiratory Questionnaire for COPD (SGRQ- C) total score comparison between treatments
time frame: 12 weeks
description: Effects comparison of indacaterol to placebo in terms of the patient-centric measurement St George's Respiratory Questionnaire for COPD (SGRQ- C) total score after 12 weeks of treatment.
measure: Comparison of Forced Expiratory Volume in one second between indacaterol and tiotropium groups
time frame: 12 weeks
description: Comparison of indacaterol to tiotropium using Trough Forced Expiratory Volume in one second.
measure: St George's Respiratory Questionnaire for COPD total score comparison between treatments
time frame: 12 weeks
description: Effects comparison of indacaterol to tiotropium in terms of St George's Respiratory Questionnaire for COPD (SGRQ- C) total score after 12 weeks of treatment.
measure: Adverse events and serious adverse events for all treatment groups
time frame: week 12
description: All adverse events will be reported
arm group label: Indacaterol
arm group type: Experimental
description: Indacaterol once daily
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo for indacaterol and placebo for tiotropium once daily
arm group label: Tiotropium
arm group type: Active Comparator
description: Tiotropium
intervention type: Drug
intervention name: Indacaterol
description: Indacaterol once daily via single-dose dry powder inhaler
arm group label: Indacaterol
intervention type: Drug
intervention name: Placebo to tiotropium
description: Placebo to tiotropium capsules for inhalation once daily
arm group label: Placebo
arm group label: Tiotropium
intervention type: Drug
intervention name: Tiotropium
description: Tiotropium capsules for inhalation once daily
arm group label: Tiotropium
other name: Tiotropium 18 mcg od via single-dose dry powder inhaler
intervention type: Drug
intervention name: Placebo to indacaterol
description: Placebo to indacaterol capsules for inhalation once daily
arm group label: Indacaterol
arm group label: Placebo
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Novartis Pharmaceuticals
role: Study Director
affiliation: Novartis Pharmaceuticals
responsible party type: Sponsor
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Tiotropium Bromide