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/NCT06003049</url>
    </required_header>
    <id_info>
      <org_study_id>COPD 101</org_study_id>
      <nct_id>NCT06003049</nct_id>
    </id_info>
    <brief_title>A Study to Evaluate Safety and Efficacy of BOTOX in Adults With Moderate COPD</brief_title>
    <official_title>An Investigator-Initiated, Single Center, Prospective, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate Safety and Efficacy of OnabotulinumtoxinA (BOTOX®) in Adults With Moderate Chronic Obstructive Pulmonary Disease (COPD)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>RMW Testing</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>RMW Testing</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 aim of this clinical trial to determine the safety and effectiveness of treating the COPD&#xD;
        symptoms with subcutaneous BOTOX injections in participants with moderate COPD.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a prospective, double-blind, randomized, placebo-controlled, investigator-initiated&#xD;
        clinical trial to assess the safety, tolerability, and efficacy using an approved drug,&#xD;
        BOTOX, in moderate COPD participants.&#xD;
  &#xD;
        Forty participants with moderate COPD, defined as mMRC Dyspnea Scale scores of grades 2 or 3&#xD;
        and CAT scores of 12 to 20, will be included. If eligibility criteria are met, subjects will&#xD;
        be randomized to either the treatment arm (BOTOX) or placebo, treated on day one and observed&#xD;
        for 90 days for safety and efficacy.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">May 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">February 1, 2024</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>This is an Investigator-initiated a clinical trial to determine the safety and preliminary efficacy of subcutaneous injections of BOTOX in participants with moderate COPD.&#xD;
  Participants will be treated with either one series of subcutaneous injections of BOTOX or of normal saline solution in the back in the T-1 to T-5 dermatome regions as indicated in Appendix A.&#xD;
  Participants' COPD status will be measured using the COPD Assessment Test (CAT), Pulmonary Function Test (Spirometry), and 6 Minute Walk Test (6MWT).</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
      <masking_description>Double-blind study</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>CAT (Average)</measure>
      <time_frame>28 days</time_frame>
      <description>The COPD Assessment Test (CAT) is assessed to capture the health status. The total score ranges from 0 to 40 points. Average change in CAT score over 28 days between treatment arms with a higher scores indicating a more significant change in health status.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>CAT (Change in Units)</measure>
      <time_frame>28 days</time_frame>
      <description>The COPD Assessment Test (CAT) is assessed to capture the health status. The total score ranges from 0 to 40 points. Portion of participants with a change in score of 2 or greater are indicating a change health status between baseline and day 28 follow-up assessment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>FEV1</measure>
      <time_frame>28 days</time_frame>
      <description>Percentage of predicted (% pred) of the forced expiratory volume in 1 second (FEV1). FEV1 values that are ratios that are higher than at baseline suggest an improving health status. Assessment at Baseline and day 28 follow-up assessment</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>FEV1/FVC</measure>
      <time_frame>28 days</time_frame>
      <description>Ratio of percentage of predicted (% pred) of the forced expiratory volume in 1 second to (FEV1ercentage of predicted (% pred) of the forced vital capacity (FVC). FEV1/FVC ratios that are higher than at baseline suggest an improving health status. Assessment at baseline and day 28 follow-up assessment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>6MWT</measure>
      <time_frame>28 days</time_frame>
      <description>The six-minute walk test (6MWT) is performed to capture the longest 6MWT for further analyses. The longer distance covered indicates an improving health status. Assessment at baseline and day 28 follow-up assessment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>COPD Exacerbations</measure>
      <time_frame>90 days</time_frame>
      <description>Exacerbations of chronic obstructive pulmonary disease (COPD) are episodes of worsening of symptoms, leading to substantial morbidity and mortality. Total number of exacerbations will be analyzed and measured at baseline, all follow-up and end of trial assessments. More exacerbations experienced over time indicate a worse health status.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse Reactions</measure>
      <time_frame>90 days</time_frame>
      <description>The number of reported adverse reactions and serious adverse events per participant. The more adverse reactions, the worse the health status of the participant measured at baseline, all follow-up and end of trial assessments.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>CAT Score</measure>
      <time_frame>90 days</time_frame>
      <description>The COPD Assessment Test (CAT) is assessed to capture the health status. The total score ranges from 0 to 40 points. Change in CAT score measured at baseline, all follow-up and end of trial assessments between treatment and placebo arms with a higher scores indicating a more significant change in health status.</description>
    </other_outcome>
    <other_outcome>
      <measure>FEV1</measure>
      <time_frame>90 days</time_frame>
      <description>Percentage of predicted (% pred) of the forced expiratory volume in 1 second (FEV1). Change in FEV1 measured at baseline, all follow-up and end of trial assessments between treatment and placebo arms with a higher scores indicating a more significant change in health status.</description>
    </other_outcome>
    <other_outcome>
      <measure>FEV1/FVC</measure>
      <time_frame>90 days</time_frame>
      <description>Ratio of percentage of predicted (% pred) of the forced expiratory volume in 1 second to (FEV1ercentage of predicted (% pred) of the forced vital capacity (FVC). FEV1/FVC measured at baseline, all follow-up and end of trial assessments between treatment and placebo arms with a higher scores indicating a more significant change in health status.</description>
    </other_outcome>
    <other_outcome>
      <measure>Vital Signs: Oxygen saturation</measure>
      <time_frame>90 days</time_frame>
      <description>Oxygen saturation (SpO2) measured at baseline, all follow-up and end of trial assessments between treatment and placebo arms with a higher scores indicating a more significant change in health status.</description>
    </other_outcome>
    <other_outcome>
      <measure>6MWT</measure>
      <time_frame>90 days</time_frame>
      <description>The six-minute walk test (6MWT) is performed to capture the longest 6MWD for further analyses. 6MWT measured at baseline, all follow-up and end of trial assessments between treatment and placebo arms with a higher scores indicating a more significant change in health status.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>COPD</condition>
    <arm_group>
      <arm_group_label>Treatment Arm</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>OnabotulinumtoxinA</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo Arm</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Normal saline</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>OnabotulinumtoxinA</intervention_name>
      <description>BOTOX injection series</description>
      <arm_group_label>Treatment Arm</arm_group_label>
      <other_name>BOTOX</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Placebo injection series</description>
      <arm_group_label>Placebo Arm</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. 18 years of age or older&#xD;
  &#xD;
            2. History of moderate COPD as diagnosed by a physician&#xD;
  &#xD;
            3. FEV1 /FVC Ratio &lt; 0.7 with Post-Bronchodilator FEV1 ≥50% of predicted value at&#xD;
               Screening&#xD;
  &#xD;
            4. Modified Medical Research Council (mMRC) Dyspnea Scale score of Grade 2 or 3 (Appendix&#xD;
               B) at Screening&#xD;
  &#xD;
            5. CAT score of 12-20 (Appendix C) measured at Screening and confirmed at Baseline&#xD;
  &#xD;
            6. Ability to consent&#xD;
  &#xD;
            7. Ability to receive subcutaneous injections along the spine/back in the T-1 &gt; T-5&#xD;
               region&#xD;
  &#xD;
            8. Females of reproductive potential must have a negative pregnancy test at screening and&#xD;
               use of highly effective contraception method (refer to section 12.3.9) for 4 weeks&#xD;
               after study drug administration and during study participation. Women are generally&#xD;
               considered to be of reproductive potential if a non-menopausal female has not had a&#xD;
               hysterectomy, bilateral oophorectomy, or medically documented ovarian failure.&#xD;
  &#xD;
            9. Males of reproductive potential must use condoms with spermicide or other methods to&#xD;
               ensure effective contraception with partner during study participation. Men are&#xD;
               generally considered to be of reproductive potential if they can produce sperm.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Any medical condition that may put the participant at increased risk with exposure to&#xD;
               botulinum toxin type A (BTX-A), including, but not limited to diagnoses of myasthenia&#xD;
               gravis (MG), Eaton-Lambert syndrome, amyotrophic lateral sclerosis, multiple&#xD;
               sclerosis, or any other significant disease that might interfere with neuromuscular&#xD;
               function&#xD;
  &#xD;
            2. Treatment of study target treatment area using acupuncture, transcutaneous electrical&#xD;
               stimulation (TENS), cranial traction or injection of anesthetics/steroids within 4&#xD;
               weeks prior to the screening visit (oral or inhaled steroids are allowed)&#xD;
  &#xD;
            3. Known allergy to BTX-A&#xD;
  &#xD;
            4. Known history of pulmonary hypertension&#xD;
  &#xD;
            5. Documented COPD exacerbation within 4 weeks of Baseline (Day 1)&#xD;
  &#xD;
            6. Post-bronchodilator FEV1 value ≤30% of the predicted value at screening&#xD;
  &#xD;
            7. Current smoker (e-cigarettes or cigarettes, cigars, pipe tobacco, vape)&#xD;
  &#xD;
            8. Prior or current lung cancer&#xD;
  &#xD;
            9. Post COVID symptoms resulting in breathing difficulties beyond pre-COVID COPD symptoms&#xD;
  &#xD;
           10. Allergy to local anesthetics&#xD;
  &#xD;
           11. History of botulism&#xD;
  &#xD;
           12. Has an active infection requiring systemic therapy&#xD;
  &#xD;
           13. Coagulopathy&#xD;
  &#xD;
           14. Pregnant or breastfeeding&#xD;
  &#xD;
           15. Requires immediate admission to hospital for any reason&#xD;
  &#xD;
           16. Any serious medical condition, such as kidney, liver, or cardiac disease, asthma,&#xD;
               angioedema, bleeding disorder, malignancy, seizure, neutropenia, AIDS, that in the&#xD;
               judgement of the Investigator could confound study assessments&#xD;
  &#xD;
           17. Any condition (physical, mental, or social), occupational reason or other&#xD;
               responsibility that, in the judgment of the Investigator, would jeopardize the safety&#xD;
               or rights of the study participant, or render the participant unable to comply with&#xD;
               the protocol, including participant's return for follow-up visits on schedule&#xD;
  &#xD;
           18. Any chronic conditions which may cause diffusion of excess of Substance P in the&#xD;
               cerebrospinal fluid (CSF), including but not limited to diabetes, chronic kidney&#xD;
               failure, cirrhosis, pancreatitis, osteoporosis, ongoing clinical depression, migraines&#xD;
               and fibromyalgia, that would compromise the participant's safety as determined by the&#xD;
               Investigator.&#xD;
  &#xD;
           19. History of keloid formation after injury.&#xD;
  &#xD;
           20. Treatment with another investigational drug or other investigational intervention&#xD;
               within 2 weeks of study start and throughout study duration&#xD;
  &#xD;
           21. Treatment with any botulinum toxin (BoNT) products within 6 months of the baseline&#xD;
               visit.&#xD;
  &#xD;
           22. Receipt of a tetanus vaccine (Td or Tdap) within 6 months of the baseline visit.&#xD;
  &#xD;
           23. Any abnormal laboratory value greater than 3 times upper limit of normal (ULN).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Victoria Do</last_name>
      <role>Principal Investigator</role>
      <affiliation>Investigator</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Victoria Do</last_name>
      <phone>713-907-6054</phone>
      <email>vdo@adhealthcare.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Michelle Wawrzyniak</last_name>
      <phone>586-747-3114</phone>
      <email>Michellew@tranquilconsulting.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Tranquil Clinical Research</name>
        <address>
          <city>Webster</city>
          <state>Texas</state>
          <zip>77598</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Amber Christian</last_name>
        <phone>713-907-6054</phone>
        <email>amberc@tranquilityresearch.com</email>
      </contact>
      <investigator>
        <last_name>Victoria Do, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Regina Pillai, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Botulinum Toxins, Type A</mesh_term>
      <mesh_term>abobotulinumtoxinA</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/NCT06003049
  org study id: COPD 101
  nct id: NCT06003049
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  The aim of this clinical trial to determine the safety and effectiveness of treating the COPD
        symptoms with subcutaneous BOTOX injections in participants with moderate COPD.
  This is a prospective, double-blind, randomized, placebo-controlled, investigator-initiated
        clinical trial to assess the safety, tolerability, and efficacy using an approved drug,
        BOTOX, in moderate COPD participants.
  
        Forty participants with moderate COPD, defined as mMRC Dyspnea Scale scores of grades 2 or 3
        and CAT scores of 12 to 20, will be included. If eligibility criteria are met, subjects will
        be randomized to either the treatment arm (BOTOX) or placebo, treated on day one and observed
        for 90 days for safety and efficacy.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: This is an Investigator-initiated a clinical trial to determine the safety and preliminary efficacy of subcutaneous injections of BOTOX in participants with moderate COPD.
  Participants will be treated with either one series of subcutaneous injections of BOTOX or of normal saline solution in the back in the T-1 to T-5 dermatome regions as indicated in Appendix A.
  Participants' COPD status will be measured using the COPD Assessment Test (CAT), Pulmonary Function Test (Spirometry), and 6 Minute Walk Test (6MWT).
  primary purpose: Treatment
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  masking description: Double-blind study
  measure: CAT (Average)
  time frame: 28 days
  description: The COPD Assessment Test (CAT) is assessed to capture the health status. The total score ranges from 0 to 40 points. Average change in CAT score over 28 days between treatment arms with a higher scores indicating a more significant change in health status.
  measure: CAT (Change in Units)
  time frame: 28 days
  description: The COPD Assessment Test (CAT) is assessed to capture the health status. The total score ranges from 0 to 40 points. Portion of participants with a change in score of 2 or greater are indicating a change health status between baseline and day 28 follow-up assessment.
  measure: FEV1
  time frame: 28 days
  description: Percentage of predicted (% pred) of the forced expiratory volume in 1 second (FEV1). FEV1 values that are ratios that are higher than at baseline suggest an improving health status. Assessment at Baseline and day 28 follow-up assessment
  measure: FEV1/FVC
  time frame: 28 days
  description: Ratio of percentage of predicted (% pred) of the forced expiratory volume in 1 second to (FEV1ercentage of predicted (% pred) of the forced vital capacity (FVC). FEV1/FVC ratios that are higher than at baseline suggest an improving health status. Assessment at baseline and day 28 follow-up assessment.
  measure: 6MWT
  time frame: 28 days
  description: The six-minute walk test (6MWT) is performed to capture the longest 6MWT for further analyses. The longer distance covered indicates an improving health status. Assessment at baseline and day 28 follow-up assessment.
  measure: COPD Exacerbations
  time frame: 90 days
  description: Exacerbations of chronic obstructive pulmonary disease (COPD) are episodes of worsening of symptoms, leading to substantial morbidity and mortality. Total number of exacerbations will be analyzed and measured at baseline, all follow-up and end of trial assessments. More exacerbations experienced over time indicate a worse health status.
  measure: Adverse Reactions
  time frame: 90 days
  description: The number of reported adverse reactions and serious adverse events per participant. The more adverse reactions, the worse the health status of the participant measured at baseline, all follow-up and end of trial assessments.
  measure: CAT Score
  time frame: 90 days
  description: The COPD Assessment Test (CAT) is assessed to capture the health status. The total score ranges from 0 to 40 points. Change in CAT score measured at baseline, all follow-up and end of trial assessments between treatment and placebo arms with a higher scores indicating a more significant change in health status.
  measure: FEV1
  time frame: 90 days
  description: Percentage of predicted (% pred) of the forced expiratory volume in 1 second (FEV1). Change in FEV1 measured at baseline, all follow-up and end of trial assessments between treatment and placebo arms with a higher scores indicating a more significant change in health status.
  measure: FEV1/FVC
  time frame: 90 days
  description: Ratio of percentage of predicted (% pred) of the forced expiratory volume in 1 second to (FEV1ercentage of predicted (% pred) of the forced vital capacity (FVC). FEV1/FVC measured at baseline, all follow-up and end of trial assessments between treatment and placebo arms with a higher scores indicating a more significant change in health status.
  measure: Vital Signs: Oxygen saturation
  time frame: 90 days
  description: Oxygen saturation (SpO2) measured at baseline, all follow-up and end of trial assessments between treatment and placebo arms with a higher scores indicating a more significant change in health status.
  measure: 6MWT
  time frame: 90 days
  description: The six-minute walk test (6MWT) is performed to capture the longest 6MWD for further analyses. 6MWT measured at baseline, all follow-up and end of trial assessments between treatment and placebo arms with a higher scores indicating a more significant change in health status.
  arm group label: Treatment Arm
  arm group type: Active Comparator
  description: OnabotulinumtoxinA
  arm group label: Placebo Arm
  arm group type: Placebo Comparator
  description: Normal saline
  intervention type: Drug
  intervention name: OnabotulinumtoxinA
  description: BOTOX injection series
  arm group label: Treatment Arm
  other name: BOTOX
  intervention type: Other
  intervention name: Placebo
  description: Placebo injection series
  arm group label: Placebo Arm
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 85 Years
  healthy volunteers: No
  last name: Victoria Do
  role: Principal Investigator
  affiliation: Investigator
  last name: Victoria Do
  phone: 713-907-6054
  email: vdo@adhealthcare.com
  last name: Michelle Wawrzyniak
  phone: 586-747-3114
  email: Michellew@tranquilconsulting.com
  facility: 
  contact: 
  investigator: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Botulinum Toxins, Type A
  mesh term: abobotulinumtoxinA
  sharing ipd: No