<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/NCT01703923</url>
  </required_header>
  <id_info>
    <org_study_id>Clin01-003</org_study_id>
    <nct_id>NCT01703923</nct_id>
  </id_info>
  <brief_title>An Exploratory Study of FP01 Lozenges in Subjects With Chronic Refractory Cough</brief_title>
  <official_title>An Exploratory, Randomized, Placebo-Controlled, Double-Blind, Crossover Study of FP01 Lozenges in Subjects With Chronic Refractory Cough</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Avalo Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Avalo Therapeutics, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the antitussive effect size and dose response of&#xD;
      FP01 lozenges in subjects with chronic cough and to demonstrate the safety and tolerability&#xD;
      of FP01 lozenges in subjects with chronic cough.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">September 2013</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cough Count/Frequency</measure>
    <time_frame>Day 0-1, Day 14-15; Day 28-29, Day 42-43</time_frame>
    <description>Change in start-to-end difference in cough count, active vs. placebo treatment periods</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>LCQ</measure>
    <time_frame>Days 0, 14, 28, &amp; 42</time_frame>
    <description>Start-to-end difference in Leicester Cough Questionnaire (LCQ) score, active vs. placebo treatment periods</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VAS Score</measure>
    <time_frame>Days 1, 14, 28, &amp; 42</time_frame>
    <description>Start-to-end difference in Visual analogue scale (VAS) score, active vs. placebo treatment periods</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cough Severity Diary</measure>
    <time_frame>Days 0, 14, 28, &amp; 42</time_frame>
    <description>Start-to-end difference in CSD score, active vs. placebo treatment periods</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">83</enrollment>
  <condition>Chronic Refractory Cough</condition>
  <arm_group>
    <arm_group_label>FP01 6mg or Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>FP01 6mg Oral</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FP01 12mg or Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>FP01 12mg Oral</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>FP01</intervention_name>
    <arm_group_label>FP01 12mg or Placebo</arm_group_label>
    <arm_group_label>FP01 6mg or Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <arm_group_label>FP01 12mg or Placebo</arm_group_label>
    <arm_group_label>FP01 6mg or Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject must sign an Institutional Review Board approved informed consent and agree to&#xD;
             complete required clinic visits&#xD;
&#xD;
          -  Subjects must be able to read and write English&#xD;
&#xD;
          -  Subject must exceed a cough severity threshold (VAS) during screening visit (Cough&#xD;
             Severity VAS Score ≥ 35 mm)&#xD;
&#xD;
          -  Mean CSD frequency domain (Only Questions 1-3 at time of screening) score &gt; 3.0&#xD;
&#xD;
          -  Stable chest X-ray&#xD;
&#xD;
          -  Forced expiratory volume 1 (FEV1) and forced vital capacity (FVC) &gt;70% predicted&#xD;
             measured using spirometry&#xD;
&#xD;
          -  Body mass index (BMI) 18.5 - 38&#xD;
&#xD;
          -  Subjects must be non-smokers or have refrained from using nicotine or nicotine&#xD;
             containing products for at least 6 months&#xD;
&#xD;
          -  Female subjects should be either post-menopausal (amenorrhea for at least 12&#xD;
             consecutive months), surgically sterile, or women of child-bearing potential with a&#xD;
             negative serum beta human chorionic gonadotropin pregnancy test prior to entering the&#xD;
             study and who are using or agree to use an acceptable method of contraception as&#xD;
             determined by the Investigator&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Recent significant change in pulmonary status or upper respiratory tract infection (&lt;4&#xD;
             weeks of randomization)&#xD;
&#xD;
          -  Female subjects who are pregnant, breast feeding or sexually active without&#xD;
             contraception.&#xD;
&#xD;
          -  History of chronic obstructive pulmonary disease (COPD)&#xD;
&#xD;
          -  History of asthma that required any significant change in treatment within 2 weeks of&#xD;
             randomization. Subjects with asthma are eligible as long as the subject is not being&#xD;
             treated with oral steroids but may enroll as long as no new medication to control&#xD;
             their asthma has been prescribed within two weeks of study enrollment.&#xD;
&#xD;
          -  History of inhalational exposure (chemical, smoke, water, etc.) within 6 months of&#xD;
             randomization&#xD;
&#xD;
          -  Chest X-ray suggestive of granulomatous disease, malignancy, pneumonia, other acute&#xD;
             pulmonary or pleural processes&#xD;
&#xD;
          -  Current treatment with angiotensin converting enzyme (ACE) inhibitors&#xD;
&#xD;
          -  Recent myocardial infarction, or history of congestive cardiac failure&#xD;
&#xD;
          -  Active, concomitant disease which might limit the ability of the subject to&#xD;
             participate in the study as determined by the Investigator (i.e., diabetes mellitus,&#xD;
             congestive heart failure, unstable angina, etc.)&#xD;
&#xD;
          -  Prior or current renal disease; calculated creatinine clearance &lt; 30 mL/min&#xD;
             (calculated CrCl &lt; 30)&#xD;
&#xD;
          -  History of Human Immunodeficiency Virus (HIV) or current clinically significant liver&#xD;
             disease&#xD;
&#xD;
          -  Use of opioids, neuromodulators (eg., gabapentin, pregabalin) first generation&#xD;
             antihistamines (eg., diphenhydramine, chlorpheniramine) or antidepressants for the&#xD;
             treatment of cough, during the study. Subjects taking drugs in these classes for&#xD;
             chronic cough at time of screening may have them discontinued at least 2 days prior to&#xD;
             randomization.&#xD;
&#xD;
          -  Use of other NMDA-receptor antagonists (e.g. dextromethorphan, ketamine, amantadine)&#xD;
             within 2 days of randomization&#xD;
&#xD;
          -  Use of any of the following medications which may interact with memantine: quinidine,&#xD;
             nicotine, neuroleptics such as chlorpromazine and promethazine, amitriptyline,&#xD;
             baclofen, warfarin and hydrochlorothiazide&#xD;
&#xD;
          -  Known hypersensitivity to memantine hydrochloride&#xD;
&#xD;
          -  Observation of oral lesion(s) or abnormal finding(s) on oral cavity examination done&#xD;
             at study screening or Day 0&#xD;
&#xD;
          -  History of oropharyngeal leukoplakia, carcinoma or parotid dysfunction&#xD;
&#xD;
          -  Subject has clinically significant abnormal laboratory test results at the screening&#xD;
             visit (Subject may be enrolled by exception, as determined by the Principal&#xD;
             Investigator and consented by Cerecor's Medical Monitor.)&#xD;
&#xD;
          -  Subject has had clinically significant bleeding or donated blood or plasma within 30&#xD;
             days of randomization&#xD;
&#xD;
          -  Subject has history of alcohol or drug abuse in past 2 years&#xD;
&#xD;
          -  Subject has a positive drug and alcohol screen. Subjects receiving benzodiazepines by&#xD;
             prescription, who test positive for benzodiazepines at the screening visit will be&#xD;
             allowed.&#xD;
&#xD;
          -  Subjects who have any disease or condition (medical or surgical) that might compromise&#xD;
             hematologic, cardiovascular, pulmonary, renal, gastrointestinal, or central nervous&#xD;
             system function; or any other conditions that might interfere with the absorption,&#xD;
             distribution, metabolism, or excretion of the study drug, or that would place the&#xD;
             subject at increased risk, as determined by the Investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Blake Paterson, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Avalo Therapeutics, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Allergy &amp; Asthma Associates of Santa Clara Valley</name>
      <address>
        <city>San Jose</city>
        <state>California</state>
        <zip>95117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sher Allergy Specialists</name>
      <address>
        <city>Largo</city>
        <state>Florida</state>
        <zip>33778</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Florida Clinical Research Trials, LLC</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33186</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>American Health Research</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Research, LLC</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oklahoma Institute of Allergy and Asthma</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allergy, Asthma and Immunology Center, P.C./ Vital Prospects Clinical Research Institute, P.C.</name>
      <address>
        <city>Tulsa</city>
        <state>Oklahoma</state>
        <zip>74136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bellingham Asthma and Allergy Associates</name>
      <address>
        <city>Bellingham</city>
        <state>Washington</state>
        <zip>98225</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>October 8, 2012</study_first_submitted>
  <study_first_submitted_qc>October 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 11, 2012</study_first_posted>
  <disposition_first_submitted>October 30, 2014</disposition_first_submitted>
  <disposition_first_submitted_qc>October 30, 2014</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">November 5, 2014</disposition_first_posted>
  <last_update_submitted>October 30, 2014</last_update_submitted>
  <last_update_submitted_qc>October 30, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 5, 2014</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>Cough</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT01703923
org study id: Clin01-003
nct id: NCT01703923
lead sponsor: 
has dmc: No
The purpose of this study is to determine the antitussive effect size and dose response of
      FP01 lozenges in subjects with chronic cough and to demonstrate the safety and tolerability
      of FP01 lozenges in subjects with chronic cough.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Cough Count/Frequency
time frame: Day 0-1, Day 14-15; Day 28-29, Day 42-43
description: Change in start-to-end difference in cough count, active vs. placebo treatment periods
measure: LCQ
time frame: Days 0, 14, 28, & 42
description: Start-to-end difference in Leicester Cough Questionnaire (LCQ) score, active vs. placebo treatment periods
measure: VAS Score
time frame: Days 1, 14, 28, & 42
description: Start-to-end difference in Visual analogue scale (VAS) score, active vs. placebo treatment periods
measure: Cough Severity Diary
time frame: Days 0, 14, 28, & 42
description: Start-to-end difference in CSD score, active vs. placebo treatment periods
arm group label: FP01 6mg or Placebo
arm group type: Experimental
description: FP01 6mg Oral
arm group label: FP01 12mg or Placebo
arm group type: Experimental
description: FP01 12mg Oral
intervention type: Drug
intervention name: FP01
arm group label: FP01 12mg or Placebo
arm group label: FP01 6mg or Placebo
intervention type: Drug
intervention name: placebo
arm group label: FP01 12mg or Placebo
arm group label: FP01 6mg or Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Blake Paterson, MD
role: Study Chair
affiliation: Avalo Therapeutics, Inc.
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cough