<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/NCT04428775</url>
  </required_header>
  <id_info>
    <org_study_id>AZT-006</org_study_id>
    <nct_id>NCT04428775</nct_id>
  </id_info>
  <brief_title>A Safety and Biomarker Study of ALZT-OP1a in Subjects With Mild-Moderate ALS Disease</brief_title>
  <official_title>A Phase IIa, Randomized, Open-label, Multi-Center, Multi-Dose Study to Evaluate the Effects of ALZT-OP1a in Subjects With Mild-Moderate Stage Amyotrophic Lateral Sclerosis (ALS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AZTherapies, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AZTherapies, Inc.</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>
      This is a Phase IIa, randomized, open-label, multi-center, multi-dose study for subjects with&#xD;
      mild to moderate ALS. The protocol is designed to determine whether ALZT-OP1a treatment will&#xD;
      positively impact neuro-inflammatory biomarkers and slow down or arrest functional decline in&#xD;
      subjects with mild to moderate ALS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This Phase IIa study is designed as a randomized, open-label, multi-center, multi-dose study&#xD;
      for subjects with mild to moderate ALS. The study will evaluate 1) safety, 2) tolerability,&#xD;
      3) changes in physical function measured using the ALSFRS-R, 4) two doses of ALZT-OP1a in&#xD;
      order to determine an optimal and effective dose that could positively impact&#xD;
      neuro-inflammatory biomarkers, and 5) to demonstrate preliminary evidence if this treatment&#xD;
      could potentially slow down or arrest functional decline in subjects with mild to moderate&#xD;
      ALS.&#xD;
&#xD;
      Up to 80 evaluable subjects will be randomly assigned to one of two treatment groups: Group I&#xD;
      (n=40) will consist of low dose ALZT-OP1a, administered via dry powder inhalation; OR Group&#xD;
      II (n=40), which will consist of high dose ALZT-OP1a, administered via dry powder inhaler.&#xD;
&#xD;
      Subjects will dose for 12 weeks and will be asked to return to the site for scheduled visits&#xD;
      and biomarker collection at Week 4, Week 8, and Week 12.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Low enrollment&#xD;
  </why_stopped>
  <start_date type="Actual">September 8, 2020</start_date>
  <completion_date type="Actual">October 1, 2021</completion_date>
  <primary_completion_date type="Actual">October 1, 2021</primary_completion_date>
  <phase>Phase 2</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>
    <intervention_model_description>Two doses of ALZT-OP1a (cromolyn) are being evaluated in this study. Each dose of ALZT-OP1a (cromolyn) will be co-administered with a stable dose of ALS standard-of-care treatment as prescribed by their physician.</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Plasma Biomarkers</measure>
    <time_frame>up to 12 weeks</time_frame>
    <description>To measure the effect of ALZT-OP1a treatment on selected plasma biomarkers in ALS patients.&#xD;
Candidate biomarkers in ng/mL include: Beta-tryptase, Beta-Hexosaminidase&#xD;
Candidate biomarkers in pg/mL include: CXCL1, interferon-y, interleukin (IL)-1a, IL-1b, IL-2, IL-5, IL-6, IL-8, IL-10, IL-15, IL-17, macrophage inflammatory protein (MIP)-1a, MIP-1b, monocyte chemoattractant protein (MCP)-1, neurofilament light protein (NfL), tumor necrosis factor (TNF)-a, and vascular endothelial growth factor (VEGF)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in ALS disease progression</measure>
    <time_frame>up to 12 weeks</time_frame>
    <description>Measured by ALS Functional Rating Scale-Revised (ALSFRS-R) - Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Event Requiring Respiratory Support</measure>
    <time_frame>up to 12 weeks</time_frame>
    <description>Measured by the time to event requiring full-time or nearly full-time respiratory support from baseline by treatment arm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in pulmonary function (forced vital capacity)</measure>
    <time_frame>up to 12 weeks</time_frame>
    <description>Measured by changes in forced vital capacity (FVC) in percent predicted value from baseline by treatment arm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in pulmonary function (peak inspiratory flow rate)</measure>
    <time_frame>up to 12 weeks</time_frame>
    <description>Measured by changes in peak inspiratory flow rate (PIFR) in liters per minute from baseline by treatment arm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse event (tolerability) related to ALZT-OP1a</measure>
    <time_frame>up to 12 weeks</time_frame>
    <description>Evaluated by number and percentage of unexpected adverse events by treatment arm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with abnormal vital signs</measure>
    <time_frame>up to 12 weeks</time_frame>
    <description>Measured by changes in systolic / diastolic blood pressure, pulse rate, respiratory rate, and body temperature from baseline by treatment arm.&#xD;
The data will also be presented in shift tables as within normal limits, clinically significant, not clinically significant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with abnormal physical or neurological examinations</measure>
    <time_frame>up to 12 weeks</time_frame>
    <description>Review of all body systems and changes evaluated for clinical significance from baseline by treatment arm.&#xD;
The data will also be presented in shift tables as within normal limits, clinically significant, not clinically significant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with abnormal electrocardiograms (ECGs)</measure>
    <time_frame>up to 12 weeks</time_frame>
    <description>Measured by changes in heart rate, PR interval, QRS complex, and QT interval from baseline by treatment arm.&#xD;
The data will also be presented in shift tables as within normal limits, clinically significant, not clinically significant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with treatment emergent clinically significant laboratory assessments</measure>
    <time_frame>up to 12 weeks</time_frame>
    <description>The abnormal values will be presented by treatment arm from baseline.&#xD;
The data will also be presented in shift tables as within normal limits, clinically significant, not clinically significant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in suicidal ideation and behavior</measure>
    <time_frame>up to 12 weeks</time_frame>
    <description>Measured by changes in Columbia Suicide Severity Rating Scale (C-SSRS) from baseline; minimum score: 0 maximum score: 10; lower values represent a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of study dropouts due to serious, unanticipated treatment emergent adverse events</measure>
    <time_frame>up to 12 weeks</time_frame>
    <description>The dropouts will be presented by treatment arm from baseline.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Amyotrophic Lateral Sclerosis</condition>
  <arm_group>
    <arm_group_label>Group I (Low Dose)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group I (n=40) will receive treatment regimen of ALZT-OP1a (cromolyn) 17.1 mg/twice a day (bid) (total of 34.2 mg/day)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group II (High Dose)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group II (n=40) will receive treatment regimen of ALZT-OP1a (cromolyn) 34.2 mg/bid (total of 68.4 mg/day)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ALZT-OP1a (cromolyn)</intervention_name>
    <description>Mast cell stabilizer&#xD;
Neuroinflammatory microglial modulator&#xD;
anti-inflammatory</description>
    <arm_group_label>Group I (Low Dose)</arm_group_label>
    <arm_group_label>Group II (High Dose)</arm_group_label>
    <other_name>Cromolyn</other_name>
    <other_name>Cromolyn sodium</other_name>
    <other_name>Sodium cromoglycate</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female subjects aged 18-75 years, both inclusive;&#xD;
&#xD;
          -  Must provide written informed consent before any study related procedures;&#xD;
&#xD;
          -  Should be capable to complete all trial related procedures, assessments and visits in&#xD;
             the judgement of Investigator;&#xD;
&#xD;
          -  Familial or sporadic ALS diagnosed as possible, laboratory-supported probable,&#xD;
             probable, or definite as defined by revised El Escorial criteria;&#xD;
&#xD;
          -  Disease duration from ALS diagnosis ≤24 months;&#xD;
&#xD;
          -  ALSFRS-R total score ≥ 36 at screening visit;&#xD;
&#xD;
          -  ALSFRS-R Breathing sub-score should be ≥9 at the time of screening;&#xD;
&#xD;
          -  ALSFRS-R Bulbar sub-score should be ≥9 at the time of screening;&#xD;
&#xD;
          -  Peak inspiratory flow rate (PIFR) ≥ 100 L/minute;&#xD;
&#xD;
          -  Forced vital capacity (FVC) &gt;70% of predicted value;&#xD;
&#xD;
          -  Participant must be receiving treatment with stable dose of standard of care treatment&#xD;
             for ≥30 days prior to signing informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with bulbar-onset ALS;&#xD;
&#xD;
          -  Any use of non-invasive ventilation (e.g., continuous positive airway pressure,&#xD;
             non-invasive bi-level positive airway pressure or non-invasive volume ventilation) for&#xD;
             any portion of the day, or mechanical ventilation via tracheostomy, or on any form of&#xD;
             oxygen supplementation;&#xD;
&#xD;
          -  Any other significant neurological disorder which can interfere with study&#xD;
             assessments, e.g., significant cognitive impairment and/or clinical dementia;&#xD;
&#xD;
          -  Significant psychiatric illness like schizophrenia, bipolar disorder etc. Subjects&#xD;
             with depression can be included, only if the depression has been stable and no episode&#xD;
             of major depression has occurred in past one year;&#xD;
&#xD;
          -  Severe cardiac disease (e.g.,corrected QT interval &gt; 500ms), Torsade de Pointes,&#xD;
             evidence of significant heart failure (New York Heart Association [NYHA] Class 3 or&#xD;
             greater, myocardial infarction or unstable angina in the 6 months prior to screening);&#xD;
&#xD;
          -  Any moderate-to-severe pulmonary disease or difficulty taking inhaled drugs;&#xD;
&#xD;
          -  Inability to tolerate the administration of an oral inhaled powder via dry powder&#xD;
             inhaler (DPI);&#xD;
&#xD;
          -  Has taken any investigational study drug within 30 days or five half-lives of the&#xD;
             drug, whichever is longer, prior to dosing;&#xD;
&#xD;
          -  Currently taking cromolyn, or has taken cromolyn, within the past 12 months;&#xD;
&#xD;
          -  Allergy to cromolyn or cromolyn products, such as Intal®, Nasalcrom®, Opticrom®,&#xD;
             Gastrocrom®, etc.;&#xD;
&#xD;
          -  Taking inhaled protein products on a chronic basis (such as insulin, parathyroid&#xD;
             hormone [PTH], etc.);&#xD;
&#xD;
          -  Subjects who weigh 88 lb (40 kg) or less, or, body mass index (BMI) of &lt;17.5 or &gt;35.0&#xD;
             at screening;&#xD;
&#xD;
          -  Moderate-to-severe liver disease: aspartate aminotransferase (AST), alanine&#xD;
             aminotransferase (ALT), or bilirubin concentrations &gt;3 times the upper limit of&#xD;
             normal; patients with hepatic diseases such as hepatic cirrhosis, hepatic cancer and&#xD;
             active hepatitis&#xD;
&#xD;
          -  Moderate-to-severe renal disease: creatinine clearance &lt;45 mL/min/1.73 m2 (by&#xD;
             Cockcroft-Gault calculation);&#xD;
&#xD;
          -  Any clinically significant disorder or laboratory abnormality that, in the&#xD;
             investigator's opinion, could interfere with the subject's participation in the study,&#xD;
             place the subject at increased risk, or confound interpretation of the study results;&#xD;
&#xD;
          -  Pregnant or breast-feeding females or sexually active females with childbearing&#xD;
             potential, if no adequate contraceptive measures are used.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David R. Elmaleh, PhD</last_name>
    <role>Study Director</role>
    <affiliation>AZTherapies, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UCSD Altman Clinical and Translational Research Institute</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital for Special Surgery</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Forest School of Medicine</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Health &amp; Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Granucci EJ, Griciuc A, Mueller KA, Mills AN, Le H, Dios AM, McGinty D, Pereira J, Elmaleh D, Berry JD, Paganoni S, Cudkowicz ME, Tanzi RE, Sadri-Vakili G. Cromolyn sodium delays disease onset and is neuroprotective in the SOD1G93A Mouse Model of amyotrophic lateral sclerosis. Sci Rep. 2019 Nov 27;9(1):17728. doi: 10.1038/s41598-019-53982-w.</citation>
    <PMID>31776380</PMID>
  </reference>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>November 1, 2021</last_update_submitted>
  <last_update_submitted_qc>November 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ALS</keyword>
  <keyword>Amyotrophic Lateral Sclerosis</keyword>
  <keyword>Lou Gehrig's disease</keyword>
  <keyword>mild ALS</keyword>
  <keyword>moderate ALS</keyword>
  <keyword>mild to moderate ALS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Motor Neuron Disease</mesh_term>
    <mesh_term>Amyotrophic Lateral Sclerosis</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cromolyn Sodium</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04428775
org study id: AZT-006
nct id: NCT04428775
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a Phase IIa, randomized, open-label, multi-center, multi-dose study for subjects with
      mild to moderate ALS. The protocol is designed to determine whether ALZT-OP1a treatment will
      positively impact neuro-inflammatory biomarkers and slow down or arrest functional decline in
      subjects with mild to moderate ALS.
This Phase IIa study is designed as a randomized, open-label, multi-center, multi-dose study
      for subjects with mild to moderate ALS. The study will evaluate 1) safety, 2) tolerability,
      3) changes in physical function measured using the ALSFRS-R, 4) two doses of ALZT-OP1a in
      order to determine an optimal and effective dose that could positively impact
      neuro-inflammatory biomarkers, and 5) to demonstrate preliminary evidence if this treatment
      could potentially slow down or arrest functional decline in subjects with mild to moderate
      ALS.

      Up to 80 evaluable subjects will be randomly assigned to one of two treatment groups: Group I
      (n=40) will consist of low dose ALZT-OP1a, administered via dry powder inhalation; OR Group
      II (n=40), which will consist of high dose ALZT-OP1a, administered via dry powder inhaler.

      Subjects will dose for 12 weeks and will be asked to return to the site for scheduled visits
      and biomarker collection at Week 4, Week 8, and Week 12.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Two doses of ALZT-OP1a (cromolyn) are being evaluated in this study. Each dose of ALZT-OP1a (cromolyn) will be co-administered with a stable dose of ALS standard-of-care treatment as prescribed by their physician.
primary purpose: Basic Science
masking: None (Open Label)
measure: Plasma Biomarkers
time frame: up to 12 weeks
description: To measure the effect of ALZT-OP1a treatment on selected plasma biomarkers in ALS patients.
Candidate biomarkers in ng/mL include: Beta-tryptase, Beta-Hexosaminidase
Candidate biomarkers in pg/mL include: CXCL1, interferon-y, interleukin (IL)-1a, IL-1b, IL-2, IL-5, IL-6, IL-8, IL-10, IL-15, IL-17, macrophage inflammatory protein (MIP)-1a, MIP-1b, monocyte chemoattractant protein (MCP)-1, neurofilament light protein (NfL), tumor necrosis factor (TNF)-a, and vascular endothelial growth factor (VEGF)
measure: Changes from baseline in ALS disease progression
time frame: up to 12 weeks
description: Measured by ALS Functional Rating Scale-Revised (ALSFRS-R) - Questionnaire
measure: Time to Event Requiring Respiratory Support
time frame: up to 12 weeks
description: Measured by the time to event requiring full-time or nearly full-time respiratory support from baseline by treatment arm.
measure: Changes from baseline in pulmonary function (forced vital capacity)
time frame: up to 12 weeks
description: Measured by changes in forced vital capacity (FVC) in percent predicted value from baseline by treatment arm.
measure: Changes from baseline in pulmonary function (peak inspiratory flow rate)
time frame: up to 12 weeks
description: Measured by changes in peak inspiratory flow rate (PIFR) in liters per minute from baseline by treatment arm.
measure: Incidence of adverse event (tolerability) related to ALZT-OP1a
time frame: up to 12 weeks
description: Evaluated by number and percentage of unexpected adverse events by treatment arm.
measure: Number of participants with abnormal vital signs
time frame: up to 12 weeks
description: Measured by changes in systolic / diastolic blood pressure, pulse rate, respiratory rate, and body temperature from baseline by treatment arm.
The data will also be presented in shift tables as within normal limits, clinically significant, not clinically significant.
measure: Number of participants with abnormal physical or neurological examinations
time frame: up to 12 weeks
description: Review of all body systems and changes evaluated for clinical significance from baseline by treatment arm.
The data will also be presented in shift tables as within normal limits, clinically significant, not clinically significant.
measure: Number of participants with abnormal electrocardiograms (ECGs)
time frame: up to 12 weeks
description: Measured by changes in heart rate, PR interval, QRS complex, and QT interval from baseline by treatment arm.
The data will also be presented in shift tables as within normal limits, clinically significant, not clinically significant.
measure: Number of participants with treatment emergent clinically significant laboratory assessments
time frame: up to 12 weeks
description: The abnormal values will be presented by treatment arm from baseline.
The data will also be presented in shift tables as within normal limits, clinically significant, not clinically significant.
measure: Changes from baseline in suicidal ideation and behavior
time frame: up to 12 weeks
description: Measured by changes in Columbia Suicide Severity Rating Scale (C-SSRS) from baseline; minimum score: 0 maximum score: 10; lower values represent a better outcome.
measure: The number of study dropouts due to serious, unanticipated treatment emergent adverse events
time frame: up to 12 weeks
description: The dropouts will be presented by treatment arm from baseline.
arm group label: Group I (Low Dose)
arm group type: Experimental
description: Group I (n=40) will receive treatment regimen of ALZT-OP1a (cromolyn) 17.1 mg/twice a day (bid) (total of 34.2 mg/day)
arm group label: Group II (High Dose)
arm group type: Experimental
description: Group II (n=40) will receive treatment regimen of ALZT-OP1a (cromolyn) 34.2 mg/bid (total of 68.4 mg/day)
intervention type: Drug
intervention name: ALZT-OP1a (cromolyn)
description: Mast cell stabilizer
Neuroinflammatory microglial modulator
anti-inflammatory
arm group label: Group I (Low Dose)
arm group label: Group II (High Dose)
other name: Cromolyn
other name: Cromolyn sodium
other name: Sodium cromoglycate
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: David R. Elmaleh, PhD
role: Study Director
affiliation: AZTherapies, Inc.
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
citation: Granucci EJ, Griciuc A, Mueller KA, Mills AN, Le H, Dios AM, McGinty D, Pereira J, Elmaleh D, Berry JD, Paganoni S, Cudkowicz ME, Tanzi RE, Sadri-Vakili G. Cromolyn sodium delays disease onset and is neuroprotective in the SOD1G93A Mouse Model of amyotrophic lateral sclerosis. Sci Rep. 2019 Nov 27;9(1):17728. doi: 10.1038/s41598-019-53982-w.
PMID: 31776380
responsible party type: Sponsor
mesh term: Motor Neuron Disease
mesh term: Amyotrophic Lateral Sclerosis
mesh term: Sclerosis
mesh term: Cromolyn Sodium
sharing ipd: No