<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/NCT01664767</url>
  </required_header>
  <id_info>
    <org_study_id>RTUNIFE01</org_study_id>
    <nct_id>NCT01664767</nct_id>
  </id_info>
  <brief_title>Effects of Sulfur Thermal Water Inhalation on Airway Oxidative Stress in COPD Patients</brief_title>
  <official_title>Placebo Controlled Study Evaluating the Modulatory Effects of Sulfur Thermal Water Inhalation on Superoxide Anion Levels in Exhaled Breath Condensate in COPD Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Università degli Studi di Ferrara</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Terme di Riolo Spa</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Università degli Studi di Ferrara</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The chronic obstructive pulmonary disease (COPD) is a chronic inflammatory disease of the&#xD;
      airways characterized by fixed airflow obstruction, with important systemic co-morbidities.&#xD;
      The obstruction is usually progressive and irreversible despite chronic therapy. Cigarette&#xD;
      smoking is the major cause of this disease. COPD is an important cause of morbidity and&#xD;
      mortality worldwide. Numerous studies have shown that oxidative stress plays a key role in&#xD;
      the pathogenesis of COPD. In particular, the active metabolites of oxygen such as superoxide&#xD;
      anion and the hydroxyl radical are unstable molecules that can trigger significant oxidative&#xD;
      processes at the cellular level. These molecules can alter the extracellular matrix&#xD;
      remodeling, cell respiration, cell proliferation, cellular repair and the immune response in&#xD;
      the lung. All these events are key elements in the pathogenesis of COPD.&#xD;
&#xD;
      Currently available treatments for COPD (i.e. long-acting bronchodilators and inhaled&#xD;
      corticosteroids) have not demonstrated a significant in vivo antioxidant effect. The thermal&#xD;
      inhalation treatments are a therapeutic strategy used since many years in an empirical way in&#xD;
      patients with COPD. Indeed, the evidence of effectiveness of spa treatment in patients with&#xD;
      COPD are very limited.&#xD;
&#xD;
      The aim of this in vivo study is to evaluate the modulatory effects of sulfur thermal water&#xD;
      inhalation on oxidant stress in the airways of stable COPD patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2011</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">January 2013</primary_completion_date>
  <phase>N/A</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Superoxide anion levels in exhaled breath condensate</measure>
    <time_frame>12 days</time_frame>
    <description>Levels of superoxide anion levels will be measured at recruitment (day 0) and after 12 days of inhalation. Changes between day 12 and day 0 will be evaluated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Superoxide anion levels in exhaled breath condensate</measure>
    <time_frame>42 day</time_frame>
    <description>Levels of superoxide anion will be measured at recruitment (day 0), after 12 days of inhalation (day 12) and one month after the last day oh inhalation (day 42). Changes between day 42, day 12 and day 0 will be evaluated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammatory cell counts in induced sputum</measure>
    <time_frame>42 days</time_frame>
    <description>Inflammatory cell counts in induced sputum will be measured at recruitment (day 0), after 12 days of inhalation (day 12) and one month after the last day of inhalation (day 42). Changes between day 42, day 12 and day 0 will be evaluated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical outcomes</measure>
    <time_frame>42 days</time_frame>
    <description>Spirometry and the impact of COPD on patient quality of life (performed by the COPD Assessment Test (CAT)) will be measured at recruitment (day 0), after 12 days of inhalation (day 12) and one month after the last day of inhalation (day 42). Changes between day 42, day 12 and day 0 will be evaluated.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease (COPD)</condition>
  <arm_group>
    <arm_group_label>Thermal water inhalation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will perform 12 days of sulfur thermal water inhalation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Isotonic saline inhalation</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients will perform 12 days of isotonic saline inhalation</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sulfur Thermal water</intervention_name>
    <arm_group_label>Thermal water inhalation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Isotonic saline inhalation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Forty stable moderate to severe COPD patients (Global Initiative for Chronic&#xD;
             Obstructive Lung Disease (GOLD) stage 2 and 3), according to international guidelines.&#xD;
&#xD;
          -  FEV1/FVC ratio post-bronchodilator &lt;70%&#xD;
&#xD;
          -  30% &lt; FEV1 &lt; 80%&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Atopy&#xD;
&#xD;
          -  Asthma&#xD;
&#xD;
          -  Concomitant lung diseases (e.g. lung cancer)&#xD;
&#xD;
          -  Acute infections of the respiratory tree in the previous 3 months including COPD&#xD;
             exacerbation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Research Centre on Asthma and COPD, University of Ferrara</name>
      <address>
        <city>Ferrara</city>
        <zip>44121</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>December 2013</verification_date>
  <study_first_submitted>August 10, 2012</study_first_submitted>
  <study_first_submitted_qc>August 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 14, 2012</study_first_posted>
  <last_update_submitted>December 27, 2013</last_update_submitted>
  <last_update_submitted_qc>December 27, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 30, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Università degli Studi di Ferrara</investigator_affiliation>
    <investigator_full_name>Alberto Papi, MD</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>COPD</keyword>
  <keyword>Thermal water</keyword>
  <keyword>Oxidative stress</keyword>
  <keyword>Inflammation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_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/NCT01664767
org study id: RTUNIFE01
nct id: NCT01664767
lead sponsor: 
collaborator: 
has dmc: No
The chronic obstructive pulmonary disease (COPD) is a chronic inflammatory disease of the
      airways characterized by fixed airflow obstruction, with important systemic co-morbidities.
      The obstruction is usually progressive and irreversible despite chronic therapy. Cigarette
      smoking is the major cause of this disease. COPD is an important cause of morbidity and
      mortality worldwide. Numerous studies have shown that oxidative stress plays a key role in
      the pathogenesis of COPD. In particular, the active metabolites of oxygen such as superoxide
      anion and the hydroxyl radical are unstable molecules that can trigger significant oxidative
      processes at the cellular level. These molecules can alter the extracellular matrix
      remodeling, cell respiration, cell proliferation, cellular repair and the immune response in
      the lung. All these events are key elements in the pathogenesis of COPD.

      Currently available treatments for COPD (i.e. long-acting bronchodilators and inhaled
      corticosteroids) have not demonstrated a significant in vivo antioxidant effect. The thermal
      inhalation treatments are a therapeutic strategy used since many years in an empirical way in
      patients with COPD. Indeed, the evidence of effectiveness of spa treatment in patients with
      COPD are very limited.

      The aim of this in vivo study is to evaluate the modulatory effects of sulfur thermal water
      inhalation on oxidant stress in the airways of stable COPD patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Superoxide anion levels in exhaled breath condensate
time frame: 12 days
description: Levels of superoxide anion levels will be measured at recruitment (day 0) and after 12 days of inhalation. Changes between day 12 and day 0 will be evaluated.
measure: Superoxide anion levels in exhaled breath condensate
time frame: 42 day
description: Levels of superoxide anion will be measured at recruitment (day 0), after 12 days of inhalation (day 12) and one month after the last day oh inhalation (day 42). Changes between day 42, day 12 and day 0 will be evaluated.
measure: Inflammatory cell counts in induced sputum
time frame: 42 days
description: Inflammatory cell counts in induced sputum will be measured at recruitment (day 0), after 12 days of inhalation (day 12) and one month after the last day of inhalation (day 42). Changes between day 42, day 12 and day 0 will be evaluated.
measure: Clinical outcomes
time frame: 42 days
description: Spirometry and the impact of COPD on patient quality of life (performed by the COPD Assessment Test (CAT)) will be measured at recruitment (day 0), after 12 days of inhalation (day 12) and one month after the last day of inhalation (day 42). Changes between day 42, day 12 and day 0 will be evaluated.
arm group label: Thermal water inhalation
arm group type: Experimental
description: Patients will perform 12 days of sulfur thermal water inhalation
arm group label: Isotonic saline inhalation
arm group type: Placebo Comparator
description: Patients will perform 12 days of isotonic saline inhalation
intervention type: Other
intervention name: Sulfur Thermal water
arm group label: Thermal water inhalation
intervention type: Other
intervention name: Placebo
arm group label: Isotonic saline inhalation
criteria: 
gender: All
minimum age: 50 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Università degli Studi di Ferrara
investigator full name: Alberto Papi, MD
investigator title: Professor
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive