<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/NCT03758950</url>
  </required_header>
  <id_info>
    <org_study_id>GCO 17-1936</org_study_id>
    <secondary_id>R01HL142671</secondary_id>
    <nct_id>NCT03758950</nct_id>
  </id_info>
  <brief_title>Inhaled Mometasone to Promote Reduction in Vasoocclusive Events 2</brief_title>
  <acronym>IMPROVE2</acronym>
  <official_title>Inhaled Mometasone to Promote Reduction in Vasoocclusive Events 2</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jeffrey Glassberg</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Icahn School of Medicine at Mount Sinai</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 study team proposes a triple-blind, placebo-controlled, phase II clinical trial of&#xD;
      once-daily inhaled mometasone for 48 weeks (with 4-week washout at study completion) in&#xD;
      individuals with Sickle Cell Disease (SCD) who report episodic cough or wheeze (ECW) but do&#xD;
      not have asthma. Patients will be recruited from and followed in SCD clinics at participating&#xD;
      sites. The primary endpoint will be a reduction in sVCAM level of 20% or more in comparison&#xD;
      to placebo.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Dose rationale: Mometasone furoate 220mcg dry powder inhalation is a low-moderate ICS dose&#xD;
      that can be given once daily. Higher doses can have systemic effects and systemic&#xD;
      glucocorticoids can precipitate rebound SCD pain when discontinued.&#xD;
&#xD;
      Adaptive, covariate-balanced randomization: While the sample size of the study will be fixed&#xD;
      at 80 participants, instead of standard blocked or stratified randomization, the study team&#xD;
      will use adaptive covariate-balanced randomization to minimize imbalance of important&#xD;
      covariates. This will reduce the need to use multivariable techniques (which perform poorly&#xD;
      in small samples) to adjust post hoc for differences between treatment groups. Covariates&#xD;
      will include age, use of hydroxyurea, previous rate of Emergency Department (ED) utilization&#xD;
      for SCD pain, and recruitment site.&#xD;
&#xD;
      Follow up Schedule: There will be in-person visits every 8 weeks. In addition, a blinded&#xD;
      research coordinator will contact participants by phone at 2-weeks and 4-weeks after&#xD;
      enrollment and 4-weeks after each in-person follow up to encourage protocol adherence and&#xD;
      collect data about adverse events and healthcare utilization.&#xD;
&#xD;
      Post-protocol observation period: The study will be complete at 48 weeks. A final follow up&#xD;
      visit will occur at 52 weeks (4-weeks after study protocol completed) to collect pain diary&#xD;
      and adverse event data and to identify the proportion of the ICS group who want to continue&#xD;
      ICS. In the event that individuals wish to continue ICS, the PI will contact the&#xD;
      participant's treating physician to discuss.&#xD;
&#xD;
      Data elements: A wide range of clinical and translational data will be collected during the&#xD;
      study. Baseline data will include demographic and clinical variables regarding SCD severity,&#xD;
      previous complications and respiratory surveys. Blood will be collected for standard-of-care&#xD;
      labs and analysis of serum inflammatory cytokines. Pulmonary function testing including&#xD;
      spirometry and Exhaled Nitric Oxide (eNO) will be performed. Health related quality of life&#xD;
      will be collected via ASCQ-Me survey. Patients will also be followed with follow-up phone&#xD;
      calls and prospective chart review for one year to identify hospital visits and other SCD&#xD;
      complications.&#xD;
&#xD;
      Procedures for collection of clinical and laboratory data: Data collection and management:&#xD;
      Case report forms are provided as an appendix. Data will be entered into a REDCap database,&#xD;
      which will be monitored by the Data Coordinating Team (DCT) (led by Co-I Gelijns) for&#xD;
      completion and timeliness.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 29, 2018</start_date>
  <completion_date type="Actual">May 31, 2023</completion_date>
  <primary_completion_date type="Actual">May 31, 2023</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <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>
    <masking_description>Quadruple blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Soluble Vascular Cell Adhesion Molecule (sVCAM) level</measure>
    <time_frame>Baseline and one year</time_frame>
    <description>Change in sVCAM level at one year compared to baseline. sVCAM is a biomarker used as a surrogate for red blood cell (RBC) adhesivity and overall disease severity in SCD.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reticulocyte Count level</measure>
    <time_frame>Baseline and one year</time_frame>
    <description>Change in Reticulocyte Count level at one year compared to baseline. Reticulocyte count is a secondary measure of hemolysis. In SCD, it is more reflective of hemolytic burden than any other clinically available laboratory test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Free Hemoglobin level</measure>
    <time_frame>Baseline and one year</time_frame>
    <description>Change in Free Hemoglobin level at one year compared to baseline. Free hemoglobin is a direct measure of hemolysis. It is more reflective of hemolytic burden than reticulocyte count but it is not available for clinical use.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LDH level</measure>
    <time_frame>Baseline and one year</time_frame>
    <description>Change in LDH level at one year compared to baseline. LDH is a marker of hemolysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bilirubin (Direct and Indirect) level</measure>
    <time_frame>Baseline and one year</time_frame>
    <description>Change in Bilirubin level at one year compared to baseline. Bilirubin measure of hemolysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemoglobin level</measure>
    <time_frame>Baseline and one year</time_frame>
    <description>Change in Hemoglobin level at one year compared to baseline. Hemoglobin is a clinical lab test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Leukocyte Count level</measure>
    <time_frame>Baseline and one year</time_frame>
    <description>Change in Leukocyte level at one year compared to baseline. Leukocyte is a clinical lab test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Platelet Count level</measure>
    <time_frame>Baseline and one year</time_frame>
    <description>Change in Platelet count level at one year compared to baseline. Platelet count is a clinical lab test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exhaled Nitric Oxide</measure>
    <time_frame>Baseline and one year</time_frame>
    <description>Change in eNO level at one year as compared to baseline. Nitric oxide is a marker of eosinophilic pulmonary inflammation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me) survey</measure>
    <time_frame>Baseline and one year</time_frame>
    <description>ASCQ-Me is a patient-reported outcome measurement system that evaluates and monitors the physical, mental, and social well-being of adults with sickle cell disease (SCD). ASCQ-Me uses a T-score metric in which 50 is the mean of the reference population and 10 is the standard deviation (SD) of that population.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication Adherence Self-Report Scale for Asthma (MARS-A)</measure>
    <time_frame>At one year</time_frame>
    <description>MARS-A is a 10-item, self-reported measure of adherence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brain Natriuretic Peptide</measure>
    <time_frame>Baseline and one year</time_frame>
    <description>Change in brain natriuretic peptide at one year compared to baseline. Brain natriuretic peptide is a measure of atrial stretch.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spirometry</measure>
    <time_frame>Baseline and one year</time_frame>
    <description>Change in spirometry at one year compared to baseline. Spirometry is the measure of airflow and lung function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Score</measure>
    <time_frame>Up to one year</time_frame>
    <description>Pain score on a zero to ten scale reflects &quot;yesterday's worst pain&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of ED Visits for SCD Pain</measure>
    <time_frame>One year</time_frame>
    <description>Measure of morbidity and healthcare utilization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number Hospitalizations for SCD Pain</measure>
    <time_frame>One year</time_frame>
    <description>Measure of morbidity and healthcare utilization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Observation Unit Admission for SCD Pain</measure>
    <time_frame>One year</time_frame>
    <description>Measure of morbidity and healthcare utilization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Overnight Stays for SCD Pain</measure>
    <time_frame>One year</time_frame>
    <description>Measure of morbidity and healthcare utilization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Outpatient Infusion Visits for SCD Pain</measure>
    <time_frame>One year</time_frame>
    <description>Measure of morbidity and healthcare utilization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Pneumonia Episodes</measure>
    <time_frame>One year</time_frame>
    <description>Measure of morbidity and healthcare utilization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of ICU Admissions</measure>
    <time_frame>One year</time_frame>
    <description>Measure of morbidity and healthcare utilization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Deaths</measure>
    <time_frame>One year</time_frame>
    <description>Measure of disease severity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>O-Link Inflammation Panel Serum</measure>
    <time_frame>Baseline and one year</time_frame>
    <description>Change in O-Link Inflammation Panel Serum at one year compared to baseline. A 92 analyte panel of key molecules involved in inflammation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>O-Link Inflammation Panel Sputum</measure>
    <time_frame>Baseline and one year</time_frame>
    <description>Change in O-Link Inflammation Panel Sputum at one year compared to baseline. Inflammation panel performed on sputum supernatant will be a measure of pulmonary inflammatory signatures</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Multiplex Cytokine Panel Serum</measure>
    <time_frame>Baseline and one year</time_frame>
    <description>Change in Multiplex Cytokine Panel Serum at one year compared to baseline. Key inflammatory mediators including interleukins, selectins, interferon and TNF.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sputum frequency of activated monocytes CyTOF</measure>
    <time_frame>Baseline and one year</time_frame>
    <description>Change in Sputum frequency of activated monocytes CyTOF at one year compared to baseline. Measure of pulmonary inflammation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sputum Frequency of Aged Neutrophils CyTOF</measure>
    <time_frame>Baseline and one year</time_frame>
    <description>Change in Sputum Frequency of Aged Neutrophils CyTOF at one year compared to baseline. Measure of pulmonary inflammation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sputum Immune Cell Subpopulations CyTOF</measure>
    <time_frame>Baseline and one year</time_frame>
    <description>Change in Sputum Immune Cell Subpopulations CyTOF at one year compared to baseline. Frequencies of all immune subpopulations will be calculated to identify pulmonary inflammation signatures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sputum Immune Cell Subpopulations CyTOF</measure>
    <time_frame>Baseline and one year</time_frame>
    <description>Change in Sputum Immune Cell Subpopulations CyTOF at one year compared to baseline. Measure of pulmonary inflammation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Whole Blood Frequency of Aged Neutrophils CyTOF</measure>
    <time_frame>Baseline and one year</time_frame>
    <description>Change in Whole Blood Frequency of Aged Neutrophils CyTOF at one year compared to baseline. Measure of pulmonary inflammation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Whole Blood Immune Cell Subpopulations CyTOF</measure>
    <time_frame>Baseline and one year</time_frame>
    <description>Change in Whole Blood Immune Cell Subpopulations CyTOF at one year compared to baseline. Frequencies of all immune subpopulations will be calculated to identify pulmonary inflammation signatures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6-Minute Walk Test</measure>
    <time_frame>Baseline and one year</time_frame>
    <description>Change in 6-Minute Walk Test at one year compared to baseline. The distance covered over a time of 6 minutes. Measure of cardiopulmonary exercise reserve.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Sickle Cell Disease</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Once daily inhaled placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mometasone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Inhaled Mometasone Furoate 220 mcg DPI</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Once daily inhaled placebo for 48 weeks</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mometasone</intervention_name>
    <description>Inhaled Mometasone for 48 weeks (with 4-week washout at study completion)</description>
    <arm_group_label>Mometasone</arm_group_label>
    <other_name>Inhaled Mometasone</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants age 18 and older with severe SCD phenotypes (Hb SS and Sβthalassemia0):&#xD;
&#xD;
          -  Do not have asthma (see exclusion criteria)&#xD;
&#xD;
          -  Not currently having a painful crisis (as defined by validated pain diary questions)&#xD;
&#xD;
          -  Do not have acute respiratory symptoms&#xD;
&#xD;
          -  Report of recent ECW (answers &quot;Yes&quot; to any question in Box 1)&#xD;
&#xD;
          -  Participant is already medically optimized (i.e. already on maximum dose hydroxyurea&#xD;
             unless contraindicated and not undergoing medication titration).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participant screens positive for possible undiagnosed asthma (Box 2)&#xD;
&#xD;
          -  Pregnant or planning to become pregnant&#xD;
&#xD;
          -  &gt; 15 ED visits for SCD pain over the previous 12 months (due to concern for&#xD;
             multi-factorial pain that may be less responsive to SCD therapies)&#xD;
&#xD;
          -  Have been discharged from the hospital within the previous 7 days.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeffrey Glassberg, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mount Sinai St Luke's</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>November 28, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>June 14, 2023</last_update_submitted>
  <last_update_submitted_qc>June 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Icahn School of Medicine at Mount Sinai</investigator_affiliation>
    <investigator_full_name>Jeffrey Glassberg</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Sickle Cell</keyword>
  <keyword>Inhaled Steroids</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anemia, Sickle Cell</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mometasone Furoate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03758950
org study id: GCO 17-1936
secondary id: R01HL142671
nct id: NCT03758950
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The study team proposes a triple-blind, placebo-controlled, phase II clinical trial of
      once-daily inhaled mometasone for 48 weeks (with 4-week washout at study completion) in
      individuals with Sickle Cell Disease (SCD) who report episodic cough or wheeze (ECW) but do
      not have asthma. Patients will be recruited from and followed in SCD clinics at participating
      sites. The primary endpoint will be a reduction in sVCAM level of 20% or more in comparison
      to placebo.
Dose rationale: Mometasone furoate 220mcg dry powder inhalation is a low-moderate ICS dose
      that can be given once daily. Higher doses can have systemic effects and systemic
      glucocorticoids can precipitate rebound SCD pain when discontinued.

      Adaptive, covariate-balanced randomization: While the sample size of the study will be fixed
      at 80 participants, instead of standard blocked or stratified randomization, the study team
      will use adaptive covariate-balanced randomization to minimize imbalance of important
      covariates. This will reduce the need to use multivariable techniques (which perform poorly
      in small samples) to adjust post hoc for differences between treatment groups. Covariates
      will include age, use of hydroxyurea, previous rate of Emergency Department (ED) utilization
      for SCD pain, and recruitment site.

      Follow up Schedule: There will be in-person visits every 8 weeks. In addition, a blinded
      research coordinator will contact participants by phone at 2-weeks and 4-weeks after
      enrollment and 4-weeks after each in-person follow up to encourage protocol adherence and
      collect data about adverse events and healthcare utilization.

      Post-protocol observation period: The study will be complete at 48 weeks. A final follow up
      visit will occur at 52 weeks (4-weeks after study protocol completed) to collect pain diary
      and adverse event data and to identify the proportion of the ICS group who want to continue
      ICS. In the event that individuals wish to continue ICS, the PI will contact the
      participant's treating physician to discuss.

      Data elements: A wide range of clinical and translational data will be collected during the
      study. Baseline data will include demographic and clinical variables regarding SCD severity,
      previous complications and respiratory surveys. Blood will be collected for standard-of-care
      labs and analysis of serum inflammatory cytokines. Pulmonary function testing including
      spirometry and Exhaled Nitric Oxide (eNO) will be performed. Health related quality of life
      will be collected via ASCQ-Me survey. Patients will also be followed with follow-up phone
      calls and prospective chart review for one year to identify hospital visits and other SCD
      complications.

      Procedures for collection of clinical and laboratory data: Data collection and management:
      Case report forms are provided as an appendix. Data will be entered into a REDCap database,
      which will be monitored by the Data Coordinating Team (DCT) (led by Co-I Gelijns) for
      completion and timeliness.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Quadruple blind
measure: Soluble Vascular Cell Adhesion Molecule (sVCAM) level
time frame: Baseline and one year
description: Change in sVCAM level at one year compared to baseline. sVCAM is a biomarker used as a surrogate for red blood cell (RBC) adhesivity and overall disease severity in SCD.
measure: Reticulocyte Count level
time frame: Baseline and one year
description: Change in Reticulocyte Count level at one year compared to baseline. Reticulocyte count is a secondary measure of hemolysis. In SCD, it is more reflective of hemolytic burden than any other clinically available laboratory test.
measure: Plasma Free Hemoglobin level
time frame: Baseline and one year
description: Change in Free Hemoglobin level at one year compared to baseline. Free hemoglobin is a direct measure of hemolysis. It is more reflective of hemolytic burden than reticulocyte count but it is not available for clinical use.
measure: LDH level
time frame: Baseline and one year
description: Change in LDH level at one year compared to baseline. LDH is a marker of hemolysis
measure: Bilirubin (Direct and Indirect) level
time frame: Baseline and one year
description: Change in Bilirubin level at one year compared to baseline. Bilirubin measure of hemolysis
measure: Hemoglobin level
time frame: Baseline and one year
description: Change in Hemoglobin level at one year compared to baseline. Hemoglobin is a clinical lab test
measure: Leukocyte Count level
time frame: Baseline and one year
description: Change in Leukocyte level at one year compared to baseline. Leukocyte is a clinical lab test
measure: Platelet Count level
time frame: Baseline and one year
description: Change in Platelet count level at one year compared to baseline. Platelet count is a clinical lab test
measure: Exhaled Nitric Oxide
time frame: Baseline and one year
description: Change in eNO level at one year as compared to baseline. Nitric oxide is a marker of eosinophilic pulmonary inflammation
measure: Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me) survey
time frame: Baseline and one year
description: ASCQ-Me is a patient-reported outcome measurement system that evaluates and monitors the physical, mental, and social well-being of adults with sickle cell disease (SCD). ASCQ-Me uses a T-score metric in which 50 is the mean of the reference population and 10 is the standard deviation (SD) of that population.
measure: Medication Adherence Self-Report Scale for Asthma (MARS-A)
time frame: At one year
description: MARS-A is a 10-item, self-reported measure of adherence
measure: Brain Natriuretic Peptide
time frame: Baseline and one year
description: Change in brain natriuretic peptide at one year compared to baseline. Brain natriuretic peptide is a measure of atrial stretch.
measure: Spirometry
time frame: Baseline and one year
description: Change in spirometry at one year compared to baseline. Spirometry is the measure of airflow and lung function.
measure: Pain Score
time frame: Up to one year
description: Pain score on a zero to ten scale reflects "yesterday's worst pain".
measure: Number of ED Visits for SCD Pain
time frame: One year
description: Measure of morbidity and healthcare utilization
measure: Number Hospitalizations for SCD Pain
time frame: One year
description: Measure of morbidity and healthcare utilization
measure: Number of Observation Unit Admission for SCD Pain
time frame: One year
description: Measure of morbidity and healthcare utilization
measure: Number of Overnight Stays for SCD Pain
time frame: One year
description: Measure of morbidity and healthcare utilization
measure: Number of Outpatient Infusion Visits for SCD Pain
time frame: One year
description: Measure of morbidity and healthcare utilization
measure: Number of Pneumonia Episodes
time frame: One year
description: Measure of morbidity and healthcare utilization
measure: Number of ICU Admissions
time frame: One year
description: Measure of morbidity and healthcare utilization
measure: Number of Deaths
time frame: One year
description: Measure of disease severity
measure: O-Link Inflammation Panel Serum
time frame: Baseline and one year
description: Change in O-Link Inflammation Panel Serum at one year compared to baseline. A 92 analyte panel of key molecules involved in inflammation
measure: O-Link Inflammation Panel Sputum
time frame: Baseline and one year
description: Change in O-Link Inflammation Panel Sputum at one year compared to baseline. Inflammation panel performed on sputum supernatant will be a measure of pulmonary inflammatory signatures
measure: Multiplex Cytokine Panel Serum
time frame: Baseline and one year
description: Change in Multiplex Cytokine Panel Serum at one year compared to baseline. Key inflammatory mediators including interleukins, selectins, interferon and TNF.
measure: Sputum frequency of activated monocytes CyTOF
time frame: Baseline and one year
description: Change in Sputum frequency of activated monocytes CyTOF at one year compared to baseline. Measure of pulmonary inflammation
measure: Sputum Frequency of Aged Neutrophils CyTOF
time frame: Baseline and one year
description: Change in Sputum Frequency of Aged Neutrophils CyTOF at one year compared to baseline. Measure of pulmonary inflammation
measure: Sputum Immune Cell Subpopulations CyTOF
time frame: Baseline and one year
description: Change in Sputum Immune Cell Subpopulations CyTOF at one year compared to baseline. Frequencies of all immune subpopulations will be calculated to identify pulmonary inflammation signatures.
measure: Sputum Immune Cell Subpopulations CyTOF
time frame: Baseline and one year
description: Change in Sputum Immune Cell Subpopulations CyTOF at one year compared to baseline. Measure of pulmonary inflammation
measure: Whole Blood Frequency of Aged Neutrophils CyTOF
time frame: Baseline and one year
description: Change in Whole Blood Frequency of Aged Neutrophils CyTOF at one year compared to baseline. Measure of pulmonary inflammation
measure: Whole Blood Immune Cell Subpopulations CyTOF
time frame: Baseline and one year
description: Change in Whole Blood Immune Cell Subpopulations CyTOF at one year compared to baseline. Frequencies of all immune subpopulations will be calculated to identify pulmonary inflammation signatures.
measure: 6-Minute Walk Test
time frame: Baseline and one year
description: Change in 6-Minute Walk Test at one year compared to baseline. The distance covered over a time of 6 minutes. Measure of cardiopulmonary exercise reserve.
arm group label: Placebo
arm group type: Placebo Comparator
description: Once daily inhaled placebo
arm group label: Mometasone
arm group type: Active Comparator
description: Inhaled Mometasone Furoate 220 mcg DPI
intervention type: Drug
intervention name: Placebo
description: Once daily inhaled placebo for 48 weeks
arm group label: Placebo
intervention type: Drug
intervention name: Mometasone
description: Inhaled Mometasone for 48 weeks (with 4-week washout at study completion)
arm group label: Mometasone
other name: Inhaled Mometasone
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jeffrey Glassberg, MD
role: Principal Investigator
affiliation: Icahn School of Medicine at Mount Sinai
facility: 
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Icahn School of Medicine at Mount Sinai
investigator full name: Jeffrey Glassberg
investigator title: Associate Professor
mesh term: Anemia, Sickle Cell
mesh term: Mometasone Furoate
sharing ipd: Undecided