<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/NCT03755544</url>
  </required_header>
  <id_info>
    <org_study_id>3106013</org_study_id>
    <nct_id>NCT03755544</nct_id>
  </id_info>
  <brief_title>Salmeterol/Fluticasone Easyhaler in the Treatment of Asthma and COPD</brief_title>
  <acronym>SUNNY</acronym>
  <official_title>Salmeterol/Fluticasone Easyhaler in the Treatment of Asthma and COPD; a Non-interventional Switch Study to Evaluate the Impact on Clinical Effects, Patient's Satisfaction, Preference and Use of Easyhaler</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Orion Corporation, Orion Pharma</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Orion Corporation, Orion Pharma</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A non-interventional study to assess the clinical effectiveness of Salmeterol/fluticasone&#xD;
      Easyhaler to achieve and maintain asthma or COPD control.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prospective, open-label, non-interventional, multicentre study in adult patients with&#xD;
      asthma or COPD who are treated with Salmeterol/fluticasone Easyhaler. During the study the&#xD;
      Salmeterol/fluticasone Easyhaler will be used according to the Summary of Product&#xD;
      Characteristics. Clinical effectiveness of the treatment will be evaluated with change in&#xD;
      asthma or COPD symptoms during 12 weeks treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 16, 2019</start_date>
  <completion_date type="Actual">February 13, 2020</completion_date>
  <primary_completion_date type="Actual">February 13, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Asthma Control Test (ACT)</measure>
    <time_frame>12 weeks</time_frame>
    <description>A multiple-choice questionnaire for patients with asthma, each choice is assigned a score 1-5. There are 5 questions to answer. The total score is calculated, ranging between 5 and 25. Lower scores indicate worse asthma control.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>COPD Assessment Test (CAT)</measure>
    <time_frame>12 weeks</time_frame>
    <description>A bipolar questionnaire for patients with COPD, there are 8 questions with 2 answers showing different extremes, respondents choose the numbered answer that reflects their opinion (in the range 0-5). The total score is calculated and ranges between 0 and 40. Higher scores indicate worse COPD control.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Asthma symptom control assessment</measure>
    <time_frame>12 weeks</time_frame>
    <description>A dichotomous questionnaire for patients with asthma, there are 4 questions with 'Yes' or 'No' answers, respondents choose the answer that reflects their opinion. A great number of 'Yes' answers indicate worse asthma control.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Forced expiratory volume in one second (FEV1)</measure>
    <time_frame>12 weeks</time_frame>
    <description>from spirometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feeling of Satisfaction with Inhaler questionnaire (FSI-10)</measure>
    <time_frame>12 weeks</time_frame>
    <description>patient's satisfaction with inhaler</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>A questionnaire to assess Physician's/nurse's perception of Salmeterol/fluticasone Easyhaler overall use</measure>
    <time_frame>12 weeks</time_frame>
    <description>A multiple-choice questionnaire for the physician/nurse, completed for each patient. Evaluation will be by frequency tables and summary statistics.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mini-AQLQ questionnaire</measure>
    <time_frame>12 weeks</time_frame>
    <description>A multiple-choice questionnaire for patients with asthma, each choice is assigned a score 1-7. There are 15 questions to answer. The total score is calculated and ranges between 15 and 105. Lower scores indicate worse quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health care utilisation questionnaire</measure>
    <time_frame>24 weeks</time_frame>
    <description>A dichotomous questionnaire for all patients, there are 6 questions, with 'Yes' or 'No' answers, to collect health care use. Evaluation will be by frequency tables and summary statistics.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Medical Research Council (mMRC) dyspnea questionnaire</measure>
    <time_frame>12 weeks</time_frame>
    <description>A bipolar questionnaire for patients with COPD, there is one question with 5 choices between two extremes, respondents choose the answer that reflects their opinion (in the range 0-4).. Higher scores indicate worse dyspnea symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptom burden and exacerbation risk assessment (ABCD classification)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Patients will be assessed by the physician, based on symptoms and exacerbation history according to the ABCD classification scheme (GOLD, 2018).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Forced vital capacity (FVC)</measure>
    <time_frame>12 weeks</time_frame>
    <description>from spirometry</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">231</enrollment>
  <condition>Asthma</condition>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <arm_group>
    <arm_group_label>Asthma patients</arm_group_label>
    <description>Male or female patients with diagnosed asthma who have been using salmeterol/fluticasone propionate combination treatment for at least 3 months before the beginning of the study, and for whom the decision has already been made to switch to Salmeterol/fluticasone Easyhaler.&#xD;
During the study, the Salmeterol/fluticasone Easyhaler will be used according to the local Summary of Product Characteristics (SmPC).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>COPD patients</arm_group_label>
    <description>Male or female patients with diagnosed COPD who have been using salmeterol/fluticasone propionate combination treatment for at least 3 months before the beginning of the study, and for whom the decision has already been made to switch to Salmeterol/fluticasone Easyhaler.&#xD;
During the study, the Salmeterol/fluticasone Easyhaler will be used according to the local Summary of Product Characteristics (SmPC).</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients will be enrolled by physicians from outpatient clinics&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Main Inclusion Criteria:&#xD;
&#xD;
          1. Male or female patients with asthma or COPD who have been using salmeterol/fluticasone&#xD;
             propionate combination treatment for at least 3 months before the study&#xD;
&#xD;
          2. Age ≥18 years.&#xD;
&#xD;
          3. Written informed consent obtained.&#xD;
&#xD;
        Main Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant or lactating female patients.&#xD;
&#xD;
          2. Participation in other clinical studies during the study.&#xD;
&#xD;
          3. Known hypersensitivity (allergy) to salmeterol, fluticasone propionate or the&#xD;
             excipient lactose&#xD;
&#xD;
          4. Any significant medical disease or condition or other factor that might interfere with&#xD;
             study assessments or study participation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Orion Pharma Clinical Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Orion Corporation, Orion Pharma</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lungenpraxis</name>
      <address>
        <city>Hamburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 22, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>February 27, 2020</last_update_submitted>
  <last_update_submitted_qc>February 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 28, 2020</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>Asthma</mesh_term>
    <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/NCT03755544
org study id: 3106013
nct id: NCT03755544
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A non-interventional study to assess the clinical effectiveness of Salmeterol/fluticasone
      Easyhaler to achieve and maintain asthma or COPD control.
A prospective, open-label, non-interventional, multicentre study in adult patients with
      asthma or COPD who are treated with Salmeterol/fluticasone Easyhaler. During the study the
      Salmeterol/fluticasone Easyhaler will be used according to the Summary of Product
      Characteristics. Clinical effectiveness of the treatment will be evaluated with change in
      asthma or COPD symptoms during 12 weeks treatment.
observational model: Cohort
time perspective: Prospective
measure: Asthma Control Test (ACT)
time frame: 12 weeks
description: A multiple-choice questionnaire for patients with asthma, each choice is assigned a score 1-5. There are 5 questions to answer. The total score is calculated, ranging between 5 and 25. Lower scores indicate worse asthma control.
measure: COPD Assessment Test (CAT)
time frame: 12 weeks
description: A bipolar questionnaire for patients with COPD, there are 8 questions with 2 answers showing different extremes, respondents choose the numbered answer that reflects their opinion (in the range 0-5). The total score is calculated and ranges between 0 and 40. Higher scores indicate worse COPD control.
measure: Asthma symptom control assessment
time frame: 12 weeks
description: A dichotomous questionnaire for patients with asthma, there are 4 questions with 'Yes' or 'No' answers, respondents choose the answer that reflects their opinion. A great number of 'Yes' answers indicate worse asthma control.
measure: Forced expiratory volume in one second (FEV1)
time frame: 12 weeks
description: from spirometry
measure: Feeling of Satisfaction with Inhaler questionnaire (FSI-10)
time frame: 12 weeks
description: patient's satisfaction with inhaler
measure: A questionnaire to assess Physician's/nurse's perception of Salmeterol/fluticasone Easyhaler overall use
time frame: 12 weeks
description: A multiple-choice questionnaire for the physician/nurse, completed for each patient. Evaluation will be by frequency tables and summary statistics.
measure: Mini-AQLQ questionnaire
time frame: 12 weeks
description: A multiple-choice questionnaire for patients with asthma, each choice is assigned a score 1-7. There are 15 questions to answer. The total score is calculated and ranges between 15 and 105. Lower scores indicate worse quality of life.
measure: Health care utilisation questionnaire
time frame: 24 weeks
description: A dichotomous questionnaire for all patients, there are 6 questions, with 'Yes' or 'No' answers, to collect health care use. Evaluation will be by frequency tables and summary statistics.
measure: Modified Medical Research Council (mMRC) dyspnea questionnaire
time frame: 12 weeks
description: A bipolar questionnaire for patients with COPD, there is one question with 5 choices between two extremes, respondents choose the answer that reflects their opinion (in the range 0-4).. Higher scores indicate worse dyspnea symptoms.
measure: Symptom burden and exacerbation risk assessment (ABCD classification)
time frame: 12 weeks
description: Patients will be assessed by the physician, based on symptoms and exacerbation history according to the ABCD classification scheme (GOLD, 2018).
measure: Forced vital capacity (FVC)
time frame: 12 weeks
description: from spirometry
arm group label: Asthma patients
description: Male or female patients with diagnosed asthma who have been using salmeterol/fluticasone propionate combination treatment for at least 3 months before the beginning of the study, and for whom the decision has already been made to switch to Salmeterol/fluticasone Easyhaler.
During the study, the Salmeterol/fluticasone Easyhaler will be used according to the local Summary of Product Characteristics (SmPC).
arm group label: COPD patients
description: Male or female patients with diagnosed COPD who have been using salmeterol/fluticasone propionate combination treatment for at least 3 months before the beginning of the study, and for whom the decision has already been made to switch to Salmeterol/fluticasone Easyhaler.
During the study, the Salmeterol/fluticasone Easyhaler will be used according to the local Summary of Product Characteristics (SmPC).
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Orion Pharma Clinical Study Director
role: Study Director
affiliation: Orion Corporation, Orion Pharma
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Asthma
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive