<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/NCT03839433</url>
  </required_header>
  <id_info>
    <org_study_id>BY 9010 / CH-101</org_study_id>
    <nct_id>NCT03839433</nct_id>
  </id_info>
  <brief_title>The Mannitol-Asthma-Ciclesonide-Study</brief_title>
  <acronym>MACS</acronym>
  <official_title>Ciclesonide for the Treatment of Airway Hyperresponsiveness: The Mannitol-Asthma-Ciclesonide-Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cantonal Hosptal, Baselland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cantonal Hosptal, Baselland</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Response of a 4 weeks treatment with daily once 320 µg ciclesonide on airway&#xD;
      hyperresponsiveness assessed with mannitol.&#xD;
&#xD;
      Hypothesis: Treatment with inhaled ciclesonide reduces airway hyper-responsiveness in 80% of&#xD;
      hyper-responsive patients compared to 20% only in the placebo group and the group without&#xD;
      airway hyper-responsiveness.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2007</start_date>
  <completion_date type="Actual">August 2008</completion_date>
  <primary_completion_date type="Actual">August 2008</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of hyperresponsiveness to mannitol by measuring PD15 FEV1 after 4 weeks (improvement of more than at least 1.5 doubling dose)</measure>
    <time_frame>4 weeks</time_frame>
    <description>measurements of PD15 FEV1 (provocative dose to produce a 15% fall in FEV1), bronchial hyperresponsiveness. A 15 % reduction of FEV1 means a bronchial hyperresponsiveness</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in PD20 FEV1 methacholine (Responsiveness to metacholine)</measure>
    <time_frame>4 weeks</time_frame>
    <description>measurements of PD20 FEV1 (provocative dose to produce a 20% fall in FEV1) bronchial hyperresponsiveness. A 20 % reduction of FEV1 means a bronchial hyperresponsiveness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in FeNO (Nitric Oxide)</measure>
    <time_frame>4 weeks</time_frame>
    <description>Measurement of bronchial inflammation. It determines the level of nitric oxide in parts per billion (PPB). Nitric oxide in exhaled air is another marker of airway inflammation. Subjects with atopic asthma or rhinitis seem to have elevated expiratory nitric oxide (eNO) levels.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in ACQ (Asthma Control Questionnaire)</measure>
    <time_frame>4 weeks</time_frame>
    <description>It measures both the adequacy of asthma control and change in asthma control, which occurs either spontaneously or as a result of treatment. It measures both the adequacy of asthma control and change in asthma control, which occurs either spontaneously or as a result of treatment. The ACQ has 7 questions (the top scoring 5 symptoms, FEV1% pred. and daily rescue bronchodilator use). Patients are asked to recall how their asthma has been during the previous week and to respond to the symptom and bronchodilator use questions on a 7-point scale (0=no impairment, 6= maximum impairment). Clinic staff score the FEV1% predicted on a 7-point scale. The questions are equally weighted and the ACQ score is the mean of the 7 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AQLQ (Asthma Quality of Life Questionnaire)</measure>
    <time_frame>4 weeks</time_frame>
    <description>The Asthma Quality of Life Questionnaire (AQLQ) was developed to measure the functional problems (physical, emotional, social and occupational) that are most troublesome to adults (17-70 years) with asthma. There are 32 questions in the AQLQ and they are in 4 domains (symptoms, activity limitation, emotional function and environmental stimuli). The activity domain contains 5 'patient-specific' questions. This allows patients to select 5 activities in which they are most limited and these activities will be assessed at each follow-up. Patients are asked to think about how they have been during the previous two weeks and to respond to each of the 32 questions on a 7-point scale (7 = not impaired at all - 1 = severely impaired). The overall AQLQ score is the mean of all 32 responses and the individual domain scores are the means of the items in those domains.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Asthma, Bronchial</condition>
  <arm_group>
    <arm_group_label>ciclesonide positive</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Half of the Mannitol positive patients were given ciclesonide. Half of the Mannitol negative patients were given ciclesonide. All patients in the &quot;ciclesonide positive&quot; arm received ciclesonide.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Half of the Mannitol positive patients were given a placebo. Half of the Mannitol negative patients were given a placebo. All patients in the &quot;placebo&quot; arm received placebo.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ciclesonide</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>ciclesonide positive</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Referred to the pulmonology department of the university hospital Basel because of&#xD;
             suspected asthma defined as respiratory symptoms like wheezing or cough or chest&#xD;
             tightness.&#xD;
&#xD;
          -  Asthma symptoms partly controlled according to GINA (Global Initiative for Asthma,&#xD;
             October 2006) 1 week prior to randomization&#xD;
&#xD;
          -  FEV1 ≥ 70% predicted&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Smoker and ex-smoker with &gt;10 pack years&#xD;
&#xD;
          -  COPD (chronic obstructive pulmonary disease)&#xD;
&#xD;
          -  Upper respiratory tract infection within the past 4 weeks.&#xD;
&#xD;
          -  ICS or oral steroids during the previous month before inclusion&#xD;
&#xD;
          -  beta-blockers within the past 4 weeks&#xD;
&#xD;
          -  Current treatment with medication as defined in section concomitant medication (ICS&#xD;
             other than study medication, ß-blockers)&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Known malignancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>August 4, 2017</study_first_submitted>
  <study_first_submitted_qc>February 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>July 23, 2019</last_update_submitted>
  <last_update_submitted_qc>July 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cantonal Hosptal, Baselland</investigator_affiliation>
    <investigator_full_name>Prof. Dr. Jörg Leuppi</investigator_full_name>
    <investigator_title>Prof. Dr.</investigator_title>
  </responsible_party>
  <keyword>Asthma</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>Ciclesonide</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/NCT03839433
org study id: BY 9010 / CH-101
nct id: NCT03839433
lead sponsor: 
has dmc: No
Response of a 4 weeks treatment with daily once 320 µg ciclesonide on airway
      hyperresponsiveness assessed with mannitol.

      Hypothesis: Treatment with inhaled ciclesonide reduces airway hyper-responsiveness in 80% of
      hyper-responsive patients compared to 20% only in the placebo group and the group without
      airway hyper-responsiveness.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change of hyperresponsiveness to mannitol by measuring PD15 FEV1 after 4 weeks (improvement of more than at least 1.5 doubling dose)
time frame: 4 weeks
description: measurements of PD15 FEV1 (provocative dose to produce a 15% fall in FEV1), bronchial hyperresponsiveness. A 15 % reduction of FEV1 means a bronchial hyperresponsiveness
measure: Change in PD20 FEV1 methacholine (Responsiveness to metacholine)
time frame: 4 weeks
description: measurements of PD20 FEV1 (provocative dose to produce a 20% fall in FEV1) bronchial hyperresponsiveness. A 20 % reduction of FEV1 means a bronchial hyperresponsiveness
measure: Change in FeNO (Nitric Oxide)
time frame: 4 weeks
description: Measurement of bronchial inflammation. It determines the level of nitric oxide in parts per billion (PPB). Nitric oxide in exhaled air is another marker of airway inflammation. Subjects with atopic asthma or rhinitis seem to have elevated expiratory nitric oxide (eNO) levels.
measure: Change in ACQ (Asthma Control Questionnaire)
time frame: 4 weeks
description: It measures both the adequacy of asthma control and change in asthma control, which occurs either spontaneously or as a result of treatment. It measures both the adequacy of asthma control and change in asthma control, which occurs either spontaneously or as a result of treatment. The ACQ has 7 questions (the top scoring 5 symptoms, FEV1% pred. and daily rescue bronchodilator use). Patients are asked to recall how their asthma has been during the previous week and to respond to the symptom and bronchodilator use questions on a 7-point scale (0=no impairment, 6= maximum impairment). Clinic staff score the FEV1% predicted on a 7-point scale. The questions are equally weighted and the ACQ score is the mean of the 7 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).
measure: AQLQ (Asthma Quality of Life Questionnaire)
time frame: 4 weeks
description: The Asthma Quality of Life Questionnaire (AQLQ) was developed to measure the functional problems (physical, emotional, social and occupational) that are most troublesome to adults (17-70 years) with asthma. There are 32 questions in the AQLQ and they are in 4 domains (symptoms, activity limitation, emotional function and environmental stimuli). The activity domain contains 5 'patient-specific' questions. This allows patients to select 5 activities in which they are most limited and these activities will be assessed at each follow-up. Patients are asked to think about how they have been during the previous two weeks and to respond to each of the 32 questions on a 7-point scale (7 = not impaired at all - 1 = severely impaired). The overall AQLQ score is the mean of all 32 responses and the individual domain scores are the means of the items in those domains.
arm group label: ciclesonide positive
arm group type: Active Comparator
description: Half of the Mannitol positive patients were given ciclesonide. Half of the Mannitol negative patients were given ciclesonide. All patients in the "ciclesonide positive" arm received ciclesonide.
arm group label: Placebo
arm group type: Placebo Comparator
description: Half of the Mannitol positive patients were given a placebo. Half of the Mannitol negative patients were given a placebo. All patients in the "placebo" arm received placebo.
intervention type: Drug
intervention name: Ciclesonide
arm group label: Placebo
arm group label: ciclesonide positive
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Cantonal Hosptal, Baselland
investigator full name: Prof. Dr. Jörg Leuppi
investigator title: Prof. Dr.
mesh term: Asthma
mesh term: Ciclesonide