xml: <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/NCT06040268</url>
    </required_header>
    <id_info>
      <org_study_id>23-0463</org_study_id>
      <secondary_id>W81WXH2290024</secondary_id>
      <nct_id>NCT06040268</nct_id>
    </id_info>
    <brief_title>Advair HFA in Healthy and HAPE Predisposed Subjects</brief_title>
    <acronym>SWIFTARC</acronym>
    <official_title>A Double-Blinded, Placebo-Controlled, Randomized, 2 Period, Crossover Phase 1/2a Study to Test the Safety and Efficacy of Advair HFA (Salmeterol and Fluticasone) in Resting and Exercising Healthy and High Altitude Pulmonary Edema (HAPE) Predisposed Subjects</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Colorado, Denver</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>United States Department of Defense</agency>
        <agency_class>U.S. Fed</agency_class>
      </collaborator>
      <collaborator>
        <agency>MTEC</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Colorado, Denver</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The current protocol is composed of two studies. The first study is designed to carefully&#xD;
        evaluate the safety of high-dose salmeterol/fluticasone administration over 7 days, as well&#xD;
        as the efficacy of the study drug to increase exercise performance, in healthy individuals&#xD;
        exercising under hypoxic, simulated high-altitude conditions (Phase 1/2a study). The second&#xD;
        study will examine sensitive measures of cardiopulmonary function using invasive&#xD;
        cardiopulmonary testing, in both HAPE-sensitive and HAPE-resistant individuals, to assess the&#xD;
        potential efficacy of salmeterol/fluticasone to prevent pulmonary edema and to enhance&#xD;
        exercise capacity (Phase 2a) in these individuals.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Both Study 1 and Study 2 are double-blinded, randomized, placebo-controlled, two-period,&#xD;
        crossover studies.&#xD;
  &#xD;
        Study 1 (Phase 1/2a) is a Double-Blinded, Placebo-Controlled, Randomized, 2 Period, Crossover&#xD;
        study examining safety and efficacy in healthy subjects dosed with salmeterol/fluticasone&#xD;
        126mcg/270mcg twice daily vs. placebo, for 7 days. Subjects will exercise under hypoxic&#xD;
        conditions one time during each study period with the primary efficacy outcome being maximal&#xD;
        oxygen uptake (VO2max), and secondary outcomes of PaO2, Aa gradient, and blood lactate&#xD;
        levels. Continuous cardiac monitoring will occur during study drug dosing and for 5 days&#xD;
        after drug discontinuation. ECGs and safety lab tests will be assessed at key intervals&#xD;
        during drug dosing. A pause in enrollment will occur for a planned DSMB safety analysis after&#xD;
        four subjects have completed Study 1. There will also be a full review of safety data once&#xD;
        Study 1 is complete prior to initiating Study 2.&#xD;
  &#xD;
        Study 2 (Phase 2a) is a Double-Blinded, Placebo-Controlled, Randomized, 2 Period, Crossover&#xD;
        study examining efficacy and safety in both healthy (HAPE-resistant) and HAPE-susceptible&#xD;
        subjects dosed with salmeterol/fluticasone 126mcg/270mcg twice daily. Subjects will take&#xD;
        study drug for two days prior to hypoxic exercise testing in each period of this study, then&#xD;
        discontinue study drug when the exercise is completed. Efficacy assessments will include VO2&#xD;
        max (primary outcome), right heart catheter measurements, PaO2, A-a gradients, and blood&#xD;
        lactate.&#xD;
  &#xD;
        For both studies, investigators and subjects will be blinded to assignment group (order of&#xD;
        study drug vs. placebo).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">November 15, 2026</completion_date>
    <primary_completion_date type="Anticipated">November 1, 2026</primary_completion_date>
    <phase>Phase 1/Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Crossover Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>VO2 max</measure>
      <time_frame>day 3 of treatment</time_frame>
      <description>peak oxygen consumption with exercise</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Aa Gradient</measure>
      <time_frame>day 3 of treatment</time_frame>
      <description>alveolar-arterial oxygen Gradient during peak hypoxic exercise</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>blood lactate</measure>
      <time_frame>day 3 of treatment</time_frame>
      <description>peak arterial blood lactate during peak hypoxic exercise</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>nadir PaO2</measure>
      <time_frame>day 3 of treatment</time_frame>
      <description>lowest arterial partial pressure of oxygen during peak hypoxic exercise</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>highest PaO2</measure>
      <time_frame>day 3 of treatment</time_frame>
      <description>highest arterial partial pressure of oxygen during peak hypoxic exercise</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>MPAP</measure>
      <time_frame>day 3 of treatment</time_frame>
      <description>highest mean pulmonary arterial pressure during hypoxic exercise</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>cardiac output</measure>
      <time_frame>day 3 of treatment</time_frame>
      <description>highest cardiac output during hypoxic exercise</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Cardiac rhythm</measure>
      <time_frame>Up to 7 days of treatment</time_frame>
      <description>Safety as measured by number of subjects with symptomatic ectopy on continuous cardiac monitoring</description>
    </other_outcome>
    <other_outcome>
      <measure>Cardiac rhythm</measure>
      <time_frame>Up to 7 days of treatment</time_frame>
      <description>Safety as measured by number of subjects with asymptomatic ectopy/tachyarrythmias on continuous cardiac monitoring</description>
    </other_outcome>
    <other_outcome>
      <measure>Serum potassium</measure>
      <time_frame>Up to 7 days of treatment</time_frame>
      <description>Safety as measured by number of subjects with serum potassium &lt; 3.3</description>
    </other_outcome>
    <other_outcome>
      <measure>QTc</measure>
      <time_frame>Up to 7 days of treatment</time_frame>
      <description>Safety as measured by number of subjects with QTc interval prolongation &gt; 30 msec on 12-lead EKG</description>
    </other_outcome>
    <other_outcome>
      <measure>Drug discontinuation</measure>
      <time_frame>up to 7 days of treatment</time_frame>
      <description>Number of subjects with adverse event-related study drug discontinuation (compared to placebo)</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Altitude Edema</condition>
    <arm_group>
      <arm_group_label>Advair HFA (salmeterol 126 ug/fluticasone 270 ug) twice daily for up to 7 days</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will inhale salmeterol 126 ug and fluticasone 270 ug twice daily for up to 7 days</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Participants will inhale placebo (same puff number) twice daily for up to 7 days</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Advair HFA</intervention_name>
      <description>6 puffs (total: salmeterol 126 ug and fluticasone 270 ug) twice daily</description>
      <arm_group_label>Advair HFA (salmeterol 126 ug/fluticasone 270 ug) twice daily for up to 7 days</arm_group_label>
      <other_name>salmeterol/fluticasone</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>HFA134a inhaler</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Written informed consent signed prior to entry into the study.&#xD;
  &#xD;
            -  Male or female age 18-50 years of age&#xD;
  &#xD;
            -  BMI ≥ 20 and &lt; 35 kg/m2&#xD;
  &#xD;
            -  Agreement to comply with the study-required interventions and treatment during the&#xD;
               full duration of the study.&#xD;
  &#xD;
            -  In good health as determined by screening medical history, physical examination, vital&#xD;
               signs (blood pressure, heart rate, respiratory rate and temperature), clinical&#xD;
               laboratory tests (CBC, PT (INR)/PTT, TSH, Total Bilirubin, blood chemistries, urine&#xD;
               drug screening), and a resting 12-lead Electrocardiogram with a 10 second rhythm&#xD;
               strip.&#xD;
  &#xD;
            -  Adequate peripheral venous access for IV insertion and blood sample collection&#xD;
               (assessments will be made prior to undergoing further assessments).&#xD;
  &#xD;
            -  HAPE-susceptible individuals (Study 2 only) must have had a medically documented&#xD;
               (hospital admission or emergency room visit) HAPE episode characterized by&#xD;
               noncardiogenic pulmonary edema and hypoxemia that occurred during high altitude travel&#xD;
               in Colorado and must reside below 3,000 feet (unacclimatized individuals; non-Colorado&#xD;
               residents).&#xD;
  &#xD;
            -  HAPE-resistant individuals (Study 2 only) will have had no evidence of HAPE during&#xD;
               high altitude travel in Colorado, and must reside below 3,000 feet (unacclimatized;&#xD;
               often being travel partners of HAPE-susceptible subjects).&#xD;
  &#xD;
            -  Healthy controls (Study 1 only) will all be Colorado residents.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Currently participating in or has been enrolled in another clinical trial within the&#xD;
               last 30 days (observational studies are acceptable).&#xD;
  &#xD;
            -  Donation of any blood or plasma in the last month, or donation of &gt;500mL of blood&#xD;
               within the 3 months preceding study drug administration.&#xD;
  &#xD;
            -  Female subjects of childbearing potential with positive serum pregnancy (beta human&#xD;
               chorionic gonadotropin) test, who are breastfeeding, plan to become pregnant during&#xD;
               the study, or decline to either be abstinent or use highly effective birth control if&#xD;
               they have sexual intercourse with a male partner (ie, oral contraceptives;&#xD;
               contraceptive patches, implants, injections, and rings; intrauterine devices [IUD],&#xD;
               both IUDs hormonally-impregnated and untreated) throughout the study and for at least&#xD;
               1 month after study completion;&#xD;
  &#xD;
            -  Known history of impaired liver function&#xD;
  &#xD;
            -  Clinically significant laboratory abnormalities (one retest is allowed at the&#xD;
               discretion of the Investigator and Medical Monitor), defined as:&#xD;
  &#xD;
                 -  Impaired renal function (estimated glomerular filtration rate [eGFR] &lt; 60&#xD;
                    mL/min/1.73 m2) as estimated using the Chronic Kidney Disease Epidemiology&#xD;
                    Collaboration (CKD-EPI) equation at screening.(81)&#xD;
  &#xD;
                 -  Serum Potassium &lt; 3.2 mM&#xD;
  &#xD;
                 -  AST or ALT &gt; 2x upper reference limit&#xD;
  &#xD;
                 -  INR &gt; 1.5&#xD;
  &#xD;
                 -  Fasting serum triglycerides &gt; 500 mg/dL (lipemic serum affects assays)&#xD;
  &#xD;
                 -  TSH &lt; 0.5 or &gt; 5 mU/L&#xD;
  &#xD;
                 -  Hemoglobin &lt; 12.0 g/dL&#xD;
  &#xD;
                 -  Bilirubin &gt; 2, unless consistent with Gilbert's disorder (indirect bilirubinemia)&#xD;
  &#xD;
                 -  Platelet count &lt; 100,000/µL&#xD;
  &#xD;
                 -  Any other abnormality deemed by the Investigator to exceed normal safety limits&#xD;
                    for this study or exclude subject participation.&#xD;
  &#xD;
            -  Cardiovascular conditions:&#xD;
  &#xD;
                 -  Clinically significant abnormal electrocardiogram at screening:&#xD;
  &#xD;
                    ▪ Clinically significant abnormal ECG results including but not limited to&#xD;
                    complete left or right bundle branch block; other ventricular conduction block&#xD;
                    (except for incomplete bundle branch blocks, QRS duration &lt; 0.12 sec) ; 2nd&#xD;
                    degree or 3rd degree atrioventricular (AV) block; sustained ventricular&#xD;
                    arrhythmia; sustained atrial arrhythmia; two or more PVC in a row; pattern of ST&#xD;
                    elevation felt consistent with cardiac ischemia; or any condition deemed&#xD;
                    clinically significant by a study investigator&#xD;
  &#xD;
                 -  Any history of congenital or acquired long QT syndrome&#xD;
  &#xD;
                 -  Any history of uncorrected re-entrant supraventricular tachycardia, atrial&#xD;
                    fibrillation, sinus tachycardia (&gt; 100 bpm at rest), or ventricular tachycardia.&#xD;
  &#xD;
                 -  Evidence of conduction abnormality including QTc prolongation on ECG, defined as&#xD;
                    &gt; 450 msec for men and &gt; 470 msec for women&#xD;
  &#xD;
                 -  Unstable angina pectoris, history of myocardial infarction (MI), transient&#xD;
                    ischemic attack (TIA) or stroke within 3 months prior to screening, or subjects&#xD;
                    who have ever undergone percutaneous coronary intervention or a coronary artery&#xD;
                    bypass or who are due to undergo these procedures at the time of screening, as&#xD;
                    evidence of atherosclerotic cardiovascular disease (ASCVD).&#xD;
  &#xD;
                 -  New York Heart Association Functional Class I-IV congestive heart failure (any&#xD;
                    congestive heart failure)&#xD;
  &#xD;
                 -  Use of any blood thinner (e.g. novel oral anticoagulant, coumadin/warfarin). Use&#xD;
                    of aspirin is acceptable for study and will not need to be discontinued prior to&#xD;
                    involvement in the study. Use of a P2Y12 inhibitor (such as clopidogrel) is also&#xD;
                    not permitted due to bleeding risks.&#xD;
  &#xD;
                 -  Use of any phosphodiesterase-5 inhibitors (as prescribed medications or obtained&#xD;
                    by other means) such as sildenafil, tadalafil, or vardenafil (as they may enhance&#xD;
                    hypoxic exercise performance)&#xD;
  &#xD;
            -  Infectious conditions:&#xD;
  &#xD;
               o Active COVID-19 or any viral upper respiratory infection suspected by symptoms&#xD;
               and/or confirmed by nasal swab PCR or rapid antigen within the past 30 days. Subjects&#xD;
               will be screened for COVID-19 at study entry by nasal swab antigen test on day 0&#xD;
               regardless of symptoms. A subject with recent COVID-19 will be allowed to participate&#xD;
               provided that the diagnosis was made more than 30 days previously, COVID-related&#xD;
               symptoms have been absent for 20 or more days, and an antigen test on day 0 is&#xD;
               negative.&#xD;
  &#xD;
            -  Concomitant Medications:&#xD;
  &#xD;
                 -  Nonselective beta-blockers including propranolol, carvedilol, and labetalol (due&#xD;
                    to antagonization of beta-2 agonist effects)&#xD;
  &#xD;
                 -  Use of any inhaled or oral beta-2 receptor agonists, or oral theophylline&#xD;
  &#xD;
                 -  Non-potassium sparing diuretics (due to hypokalemia risks)&#xD;
  &#xD;
                 -  The use of any medication known to be a strong inhibitor or strong inducer of CYP&#xD;
                    3A4/5 enzymes (cytochrome P450 isoenzymes) that metabolize salmeterol.(66) Also,&#xD;
                    any medication that has been reported to have a major or moderate interaction&#xD;
                    with salmeterol or fluticasone(82)&#xD;
  &#xD;
                 -  Use of monoamine oxidase inhibitors or tricyclic antidepressants within 2 weeks&#xD;
                    of screening&#xD;
  &#xD;
                 -  Prescription amphetamines or other sympathetic stimulants used for disorders such&#xD;
                    as narcolepsy, somnolence, or attention deficit disorder&#xD;
  &#xD;
            -  History of claustrophobia or post traumatic stress disorder that would limit use of&#xD;
               gas breathing masks or mouthpieces.&#xD;
  &#xD;
            -  Essential tremor limiting handwriting, or any tremor requiring medication.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>James P Maloney, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Univ. of Colorado, Denver</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>James P Maloney, MD</last_name>
      <phone>3037246072</phone>
      <email>james.maloney@ucdenver.edu</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 8, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Colorado, Denver</investigator_affiliation>
      <investigator_full_name>James Maloney</investigator_full_name>
      <investigator_title>Professor of Medicine</investigator_title>
    </responsible_party>
    <keyword>salmeterol</keyword>
    <keyword>fluticasone</keyword>
    <keyword>exercise performance</keyword>
    <keyword>high altitude pulmonary edema</keyword>
    <keyword>hypoxia</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pulmonary Edema</mesh_term>
      <mesh_term>Edema</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fluticasone</mesh_term>
      <mesh_term>Salmeterol Xinafoate</mesh_term>
      <mesh_term>Fluticasone-Salmeterol Drug Combination</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06040268
  org study id: 23-0463
  secondary id: W81WXH2290024
  nct id: NCT06040268
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  The current protocol is composed of two studies. The first study is designed to carefully
        evaluate the safety of high-dose salmeterol/fluticasone administration over 7 days, as well
        as the efficacy of the study drug to increase exercise performance, in healthy individuals
        exercising under hypoxic, simulated high-altitude conditions (Phase 1/2a study). The second
        study will examine sensitive measures of cardiopulmonary function using invasive
        cardiopulmonary testing, in both HAPE-sensitive and HAPE-resistant individuals, to assess the
        potential efficacy of salmeterol/fluticasone to prevent pulmonary edema and to enhance
        exercise capacity (Phase 2a) in these individuals.
  Both Study 1 and Study 2 are double-blinded, randomized, placebo-controlled, two-period,
        crossover studies.
  
        Study 1 (Phase 1/2a) is a Double-Blinded, Placebo-Controlled, Randomized, 2 Period, Crossover
        study examining safety and efficacy in healthy subjects dosed with salmeterol/fluticasone
        126mcg/270mcg twice daily vs. placebo, for 7 days. Subjects will exercise under hypoxic
        conditions one time during each study period with the primary efficacy outcome being maximal
        oxygen uptake (VO2max), and secondary outcomes of PaO2, Aa gradient, and blood lactate
        levels. Continuous cardiac monitoring will occur during study drug dosing and for 5 days
        after drug discontinuation. ECGs and safety lab tests will be assessed at key intervals
        during drug dosing. A pause in enrollment will occur for a planned DSMB safety analysis after
        four subjects have completed Study 1. There will also be a full review of safety data once
        Study 1 is complete prior to initiating Study 2.
  
        Study 2 (Phase 2a) is a Double-Blinded, Placebo-Controlled, Randomized, 2 Period, Crossover
        study examining efficacy and safety in both healthy (HAPE-resistant) and HAPE-susceptible
        subjects dosed with salmeterol/fluticasone 126mcg/270mcg twice daily. Subjects will take
        study drug for two days prior to hypoxic exercise testing in each period of this study, then
        discontinue study drug when the exercise is completed. Efficacy assessments will include VO2
        max (primary outcome), right heart catheter measurements, PaO2, A-a gradients, and blood
        lactate.
  
        For both studies, investigators and subjects will be blinded to assignment group (order of
        study drug vs. placebo).
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: VO2 max
  time frame: day 3 of treatment
  description: peak oxygen consumption with exercise
  measure: Aa Gradient
  time frame: day 3 of treatment
  description: alveolar-arterial oxygen Gradient during peak hypoxic exercise
  measure: blood lactate
  time frame: day 3 of treatment
  description: peak arterial blood lactate during peak hypoxic exercise
  measure: nadir PaO2
  time frame: day 3 of treatment
  description: lowest arterial partial pressure of oxygen during peak hypoxic exercise
  measure: highest PaO2
  time frame: day 3 of treatment
  description: highest arterial partial pressure of oxygen during peak hypoxic exercise
  measure: MPAP
  time frame: day 3 of treatment
  description: highest mean pulmonary arterial pressure during hypoxic exercise
  measure: cardiac output
  time frame: day 3 of treatment
  description: highest cardiac output during hypoxic exercise
  measure: Cardiac rhythm
  time frame: Up to 7 days of treatment
  description: Safety as measured by number of subjects with symptomatic ectopy on continuous cardiac monitoring
  measure: Cardiac rhythm
  time frame: Up to 7 days of treatment
  description: Safety as measured by number of subjects with asymptomatic ectopy/tachyarrythmias on continuous cardiac monitoring
  measure: Serum potassium
  time frame: Up to 7 days of treatment
  description: Safety as measured by number of subjects with serum potassium < 3.3
  measure: QTc
  time frame: Up to 7 days of treatment
  description: Safety as measured by number of subjects with QTc interval prolongation > 30 msec on 12-lead EKG
  measure: Drug discontinuation
  time frame: up to 7 days of treatment
  description: Number of subjects with adverse event-related study drug discontinuation (compared to placebo)
  arm group label: Advair HFA (salmeterol 126 ug/fluticasone 270 ug) twice daily for up to 7 days
  arm group type: Experimental
  description: Participants will inhale salmeterol 126 ug and fluticasone 270 ug twice daily for up to 7 days
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Participants will inhale placebo (same puff number) twice daily for up to 7 days
  intervention type: Drug
  intervention name: Advair HFA
  description: 6 puffs (total: salmeterol 126 ug and fluticasone 270 ug) twice daily
  arm group label: Advair HFA (salmeterol 126 ug/fluticasone 270 ug) twice daily for up to 7 days
  other name: salmeterol/fluticasone
  intervention type: Drug
  intervention name: Placebo
  description: HFA134a inhaler
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 50 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: James P Maloney, MD
  role: Principal Investigator
  affiliation: Univ. of Colorado, Denver
  last name: James P Maloney, MD
  phone: 3037246072
  email: james.maloney@ucdenver.edu
  responsible party type: Principal Investigator
  investigator affiliation: University of Colorado, Denver
  investigator full name: James Maloney
  investigator title: Professor of Medicine
  mesh term: Pulmonary Edema
  mesh term: Edema
  mesh term: Fluticasone
  mesh term: Salmeterol Xinafoate
  mesh term: Fluticasone-Salmeterol Drug Combination
  sharing ipd: No