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/NCT06016088</url>
    </required_header>
    <id_info>
      <org_study_id>RESPIR-102</org_study_id>
      <nct_id>NCT06016088</nct_id>
    </id_info>
    <brief_title>A Double-Blind, Active-Controlled, Multiple-Ascending Dose Study of Aerosolized RSP-1502 in Subjects With CF and Chronic PA Lung Infection</brief_title>
    <official_title>A Double-Blind, Active-Controlled, Multiple-Ascending Dose, Phase 1b Study of Aerosolized RSP-1502 Delivered Via the PARI LC Plus® Nebulizer in Subjects With Cystic Fibrosis and Chronic Pseudomonas Aeruginosa Lung Infection</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Respirion Pharmaceuticals Pty Ltd</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Respirion Pharmaceuticals Pty Ltd</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 dose escalation study will evaluate 4 doses of RSP-1502 in sequential cohorts of 8&#xD;
        subjects each. In each cohort, 6 subjects will receive RSP-1502 and 2 will receive active&#xD;
        control. Study drug (RSP-1502 or active control) will be administered by inhalation twice&#xD;
        daily (BID) for 14 days. Planned RSP 1502 doses include 300 mg tobramycin plus ascending&#xD;
        doses of CaEDTA (16 mg, 32 mg, 75 mg and 150 mg). Dose escalation will proceed after Safety&#xD;
        Review Committee (SRC) review of the safety and tolerability data from the previous cohort.&#xD;
        The SRC will determine the maximum tolerated dose (MTD) after completion of the fourth&#xD;
        cohort. Following determination of the MTD, a fifth cohort (n = 20) will be randomized (1:1)&#xD;
        to treatment with RSP 1502 (at the MTD) or active control administered BID for 14 days. All&#xD;
        subjects will be followed for 14 days after completion of dosing.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        All Cohorts:&#xD;
  &#xD;
        Screening will occur within 35 days prior to Day 1. Informed consent will be obtained prior&#xD;
        to any study procedures being performed. Eligibility assessments will be performed during&#xD;
        screening.&#xD;
  &#xD;
        Cohorts 1 to 4: Treatment Period (Day 1 to Day 14 ± 2 days) Subjects will report to the&#xD;
        testing facility on Day 1 for confirmation of eligibility. Baseline assessments and&#xD;
        measurements will be performed prior to dosing and study assessments on Day 1. Subjects will&#xD;
        be released from the testing facility following dosing and study assessments on Day 1.&#xD;
        Subjects will return to the testing facility on Days 2 and 14 for study assessments; on these&#xD;
        days, a dose of study drug will be administered in the testing facility. Study drug dosing&#xD;
        will continue until the Day 14 visit.&#xD;
  &#xD;
        Cohort 5: Treatment Period (Day 1 to Day 14 ± 2 days) Subjects will report to the testing&#xD;
        facility on Day 1 for confirmation of eligibility. Baseline assessments and measurements will&#xD;
        be performed prior to dosing and study assessments on Day 1. Subjects will return to the&#xD;
        testing facility on Day 14 for study assessments; on these days, a dose of study drug will be&#xD;
        administered in the testing facility Study drug dosing will continue until the Day 14 visit.&#xD;
  &#xD;
        All Cohorts (including Cohort 5): Follow-Up Period (Day 15 to Day 28 ± 2 days):&#xD;
  &#xD;
        On Days 7 and 21, concomitant medications and adverse events (AEs) will be assessed via a&#xD;
        phone call. Subjects will return to the testing facility on Day 28 for study assessments.&#xD;
        Subjects will be discharged from the study on Day 28 after final assessments are performed.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">February 2025</completion_date>
    <primary_completion_date type="Anticipated">February 2025</primary_completion_date>
    <phase>Phase 1/Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Treatment-emergent adverse events</measure>
      <time_frame>Day 1 through Day 28</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Treatment-emergent serious adverse events</measure>
      <time_frame>Day 1 through Day 28</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes in post-dose spirometry</measure>
      <time_frame>Day 1, Day 2, and Day 14</time_frame>
      <description>forced expiratory volume in 1 second</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pulmonary exacerbations</measure>
      <time_frame>Day 1 through Day 28</time_frame>
      <description>a period of treatment with intravenous antibiotics in the hospital and/or at home</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes in post-dose electrocardiogram results</measure>
      <time_frame>Day 1 and Day 2</time_frame>
      <description>PR interval, QRS interval, QT interval</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Pharmacokinetic parameters for CaEDTA</measure>
      <time_frame>Day 1</time_frame>
      <description>Peak serum concentration (Cmax)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pharmacokinetic parameters for CaEDTA</measure>
      <time_frame>Day 1 through Day 28</time_frame>
      <description>Exposure (area under the serum concentration versus time curve [AUC])</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pharmacokinetic parameters for CaEDTA</measure>
      <time_frame>Day 1 through Day 28</time_frame>
      <description>Time to maximum serum concentration (Tmax)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pharmacokinetic parameters for tobramycin</measure>
      <time_frame>Day 1</time_frame>
      <description>Peak serum concentration (Cmax)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pharmacokinetic parameters for tobramycin</measure>
      <time_frame>Day 1 through Day 28</time_frame>
      <description>Exposure (area under the serum concentration versus time curve [AUC])</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pharmacokinetic parameters for tobramycin</measure>
      <time_frame>Day 1</time_frame>
      <description>Time to maximum serum concentration (Tmax)</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Pharmacodynamic parameters</measure>
      <time_frame>Day 1, Day 14, and Day 28</time_frame>
      <description>Inflammatory markers in sputum</description>
    </other_outcome>
    <other_outcome>
      <measure>Microbiology parameters</measure>
      <time_frame>Day 1 to Day 14; Day 1 to Day 28</time_frame>
      <description>Change from baseline in Pseudomonas aeruginosa CFUs</description>
    </other_outcome>
    <other_outcome>
      <measure>Change from baseline in spirometry</measure>
      <time_frame>Day 1 to Day 28</time_frame>
      <description>forced expiratory volume in 1 second (absolute change; change in % predicted)</description>
    </other_outcome>
    <other_outcome>
      <measure>Change from baseline in CFQ-R Respiratory Symptoms Score</measure>
      <time_frame>Day 1 to Day 28</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Change from baseline in Chronic Respiratory Infection Symptom Score</measure>
      <time_frame>Day 1 to Day 28</time_frame>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">52</enrollment>
    <condition>Cystic Fibrosis Lung</condition>
    <condition>Respiratory Infections, Recurrent, Chronic</condition>
    <condition>Pseudomonas Aeruginosa</condition>
    <arm_group>
      <arm_group_label>RSP-1502</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Each dose of RSP-1502 includes 300 mg tobramycin and an ascending dose of CaEDTA.&#xD;
  Cohort 1: 300 mg tobramycin + 16 mg CaEDTA&#xD;
  Cohort 2: 300 mg tobramycin + 32 mg CaEDTA&#xD;
  Cohort 3: 300 mg tobramycin + 75 mg CaEDTA&#xD;
  Cohort 4: 300 mg tobramycin + 150 mg CaEDTA Cohort 5 will receive 300 mg tobramycin + CaEDTA at the MTD.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Active Control</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>• Tobramycin Inhalation Solution 300 mg.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>RSP-1502</intervention_name>
      <description>RSP 1502 is a sterile, preservative free solution to be administered by inhalation via a nebulizer. Each dose of RSP 1502 contains the active components tobramycin (60 mg/mL, 300 mg/vial) and CaEDTA. RSP 1502 contains Tromethamine USP (Tris), citric acid and sodium chloride as excipients. Additionally, sulfuric acid is used for pH adjustment.</description>
      <arm_group_label>RSP-1502</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Tobramycin inhalation solution</intervention_name>
      <description>Tobramycin inhalation solution is 300 mg tobramycin in 5 mL solution.</description>
      <arm_group_label>Active Control</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Males or females aged ≥18 years of age.&#xD;
  &#xD;
            2. Diagnosis of CF based on the following: historical positive sweat chloride value ≥ 60&#xD;
               mEq/L, and/or genotype with two identifiable mutations consistent with CF, accompanied&#xD;
               by one or more clinical features consistent with the CF phenotype.&#xD;
  &#xD;
            3. History of P. aeruginosa-positive sputum cultures or throat swabs with at least 50%&#xD;
               positive in the year preceding screening.&#xD;
  &#xD;
            4. P. aeruginosa-positive sputum culture at screening.&#xD;
  &#xD;
            5. Forced expiratory volume in 1 second (FEV1) ≥ 40 and ≤ 90% predicted per Global Lung&#xD;
               Function Initiative (GLI) equation, pre- or post-bronchodilator.&#xD;
  &#xD;
            6. Must be able to withhold all other inhaled tobramycin from Day 28 to Day 28 of study&#xD;
               participation. Must be able to withhold all other inhaled antibiotics from Day -14 to&#xD;
               Day 28.&#xD;
  &#xD;
            7. Medically stable with no evidence of significant new or acute respiratory symptoms&#xD;
               within 30 days prior to screening.&#xD;
  &#xD;
            8. Hematology, clinical chemistry, and urinalysis results with no clinically significant&#xD;
               abnormalities that would interfere with the study assessments at screening as&#xD;
               determined by the investigator.&#xD;
  &#xD;
            9. Female subjects of childbearing potential, defined as not surgically sterile or at&#xD;
               least 2 years postmenopausal, must agree to use one of the following forms of&#xD;
               contraception from screening through the Day 28 visit: hormonal (oral, implant, or&#xD;
               injection) begun &gt; 30 days prior to screening, barrier (condom, diaphragm with&#xD;
               spermicide), intrauterine device, or vasectomized partner (6 months minimum).&#xD;
  &#xD;
           10. Male subjects must show documentation of infertility or agree to use condoms during&#xD;
               study participation.&#xD;
  &#xD;
           11. Must be able to communicate with site personnel and to understand and voluntarily sign&#xD;
               the Informed Consent Form.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. A history of previous allergy or sensitivity to components of RSP 1502.&#xD;
  &#xD;
            2. A history of intolerance to inhaled tobramycin (TOBI®, BETHKIS®, TOBI® Podhaler®,&#xD;
               tobramycin inhalation solution).&#xD;
  &#xD;
            3. eGFR &lt; 40 mL/min, or serum bilirubin &gt; 2X or serum transaminases &gt; 3X the upper limit&#xD;
               of normal range at screening.&#xD;
  &#xD;
            4. Currently taking other medications with known nephrotoxic, neurotoxic, or ototoxic&#xD;
               potential.&#xD;
  &#xD;
            5. Currently taking ethacrynic acid, furosemide, urea, or intravenous mannitol.&#xD;
  &#xD;
            6. Lung infection with organisms associated with a more rapid decline in pulmonary status&#xD;
               (including, but not limited to, Burkholderia cenocepacia, Burkholderia dolosa, and&#xD;
               Mycobacterium abscessus). For subjects who have had a history of a positive culture,&#xD;
               the investigator will apply the following criteria to establish whether the subject is&#xD;
               free of infection with such organisms:&#xD;
  &#xD;
                 1. The subject has not had a respiratory tract culture positive for these organisms&#xD;
                    within the 12 months before the date of informed consent.&#xD;
  &#xD;
                 2. The subject has had at least 2 respiratory tract cultures negative for such&#xD;
                    organisms within the 12 months before the date of informed consent, with the&#xD;
                    first and last of these separated by at least 3 months, and the most recent one&#xD;
                    within the 6 months before the date of informed consent.&#xD;
  &#xD;
            7. Consistent inability to produce sputum and unwillingness to perform sputum induction.&#xD;
  &#xD;
            8. Any significant clinical/laboratory/radiological/spirometric sign of unstable or&#xD;
               unexpectedly deteriorating respiratory disease within 30 days prior to the first study&#xD;
               drug administration.&#xD;
  &#xD;
            9. Initiation or adjustment of chronic airway medications (eg, inhaled corticosteroids;&#xD;
               chronic suppressive antibacterial treatment) or airway clearance regimen (eg,&#xD;
               nebulized saline, rhDNase, initiation of mechanical vest or handheld airway clearance&#xD;
               device) within 28 days prior to screening. Individuals can be rescreened 28 days after&#xD;
               these agents/therapies have been established for at least 28 days.&#xD;
  &#xD;
           10. Is immunocompromised due to illness, or solid or hematological organ transplant.&#xD;
  &#xD;
           11. Requires systemic prednisone (or equivalent) &gt; 10 mg daily.&#xD;
  &#xD;
           12. Smoking or vaping tobacco or any substance within 6 months prior to screening and&#xD;
               anticipated inability to refrain from smoking throughout the study.&#xD;
  &#xD;
           13. Female subjects who are pregnant, lactating, or have a positive serum human chorionic&#xD;
               gonadotropin (pregnancy) test, as determined by laboratory testing.&#xD;
  &#xD;
           14. Positive result on SARS-CoV-2 (COVID-19) test assessed by rapid antigen testing (RAT)&#xD;
               at Screening or Day 1.&#xD;
  &#xD;
           15. HIV positive.&#xD;
  &#xD;
           16. Active Hepatitis B or C.&#xD;
  &#xD;
           17. History of recreational drug or alcohol use/abuse which in the opinion of the&#xD;
               investigator will compromise the patient's ability to comply with the study protocol.&#xD;
  &#xD;
           18. Participation in a clinical study with administration of an investigational drug&#xD;
               product within the previous 30 days, or five half-lives of the previously administered&#xD;
               investigational product.&#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_contact>
      <last_name>Brian Jones, PhD</last_name>
      <phone>215-732-5452</phone>
      <email>bjones@respirionpharma.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Tammy Abuan, MS</last_name>
      <phone>206-595-3851</phone>
      <email>tabuan@respirionpharma.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Tucson Cystic Fibrosis Center</name>
        <address>
          <city>Tucson</city>
          <state>Arizona</state>
          <zip>85750</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Cori Daines, MD</last_name>
      </contact>
      <investigator>
        <last_name>Cori Daines, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Center for Cystic Fibrosis at Keck Medical Center of USC</name>
        <address>
          <city>Los Angeles</city>
          <state>California</state>
          <zip>90033</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Adupa Rao, MD</last_name>
      </contact>
      <investigator>
        <last_name>Adupa Rao, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Stanford University Medical Center</name>
        <address>
          <city>Palo Alto</city>
          <state>California</state>
          <zip>94305</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Carlos Milla, MD</last_name>
      </contact>
      <investigator>
        <last_name>Carlos Milla, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Augusta University</name>
        <address>
          <city>Augusta</city>
          <state>Georgia</state>
          <zip>30912</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Caralee Forseen, MD</last_name>
      </contact>
      <investigator>
        <last_name>Caralee Forseen, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Tulane University</name>
        <address>
          <city>New Orleans</city>
          <state>Louisiana</state>
          <zip>70118</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Ross Klingsberg, MD</last_name>
      </contact>
      <investigator>
        <last_name>Ross Klingsberg, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>The Minnesota Cystic Fibrosis Center</name>
        <address>
          <city>Minneapolis</city>
          <state>Minnesota</state>
          <zip>55403</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Kathleen Mahan, MD</last_name>
      </contact>
      <investigator>
        <last_name>Kathleen Mahan, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Washington University School of Medicine</name>
        <address>
          <city>Saint Louis</city>
          <state>Missouri</state>
          <zip>63130</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Daniel Rosenbluth, MD</last_name>
      </contact>
      <investigator>
        <last_name>Daniel Rosenbluth, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Columbia University Cystic Fibrosis Program</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10027</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Claire Keating, MD</last_name>
      </contact>
      <investigator>
        <last_name>Claire Keating, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Rainbow Babies and Children's Hospital / University Hospitals Cleveland Medical Center</name>
        <address>
          <city>Cleveland</city>
          <state>Ohio</state>
          <zip>44106</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Alex Gifford, MD</last_name>
      </contact>
      <investigator>
        <last_name>Alex Gifford, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Nationwide Children's Hospital</name>
        <address>
          <city>Columbus</city>
          <state>Ohio</state>
          <zip>43205</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Karen McCoy, MD</last_name>
      </contact>
      <investigator>
        <last_name>Karen McCoy, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>University of Pennsylvania</name>
        <address>
          <city>Philadelphia</city>
          <state>Pennsylvania</state>
          <zip>19104</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Daniel Dorgan, MD</last_name>
      </contact>
      <investigator>
        <last_name>Daniel Dorgan, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Dell Children's Medical Center of Central Texas</name>
        <address>
          <city>Austin</city>
          <state>Texas</state>
          <zip>78723</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Jason Fulmer, MD</last_name>
      </contact>
      <investigator>
        <last_name>Jason Fulmer, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>The Royal Adelaide Hospital</name>
        <address>
          <city>Adelaide</city>
          <country>Australia</country>
        </address>
      </facility>
      <contact>
        <last_name>Judith Morton, MD</last_name>
      </contact>
      <investigator>
        <last_name>Judith Morton, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Institute for Respiratory Health</name>
        <address>
          <city>Perth</city>
          <country>Australia</country>
        </address>
      </facility>
      <contact>
        <last_name>Siobhain Mulrennan, MD</last_name>
      </contact>
      <investigator>
        <last_name>Siobhain Mulrennan, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Westmead Institute for Medical Research</name>
        <address>
          <city>Sydney</city>
          <country>Australia</country>
        </address>
      </facility>
      <contact>
        <last_name>Peter Middleton, MD</last_name>
      </contact>
      <investigator>
        <last_name>Peter Middleton, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Australia</country>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</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>Infections</mesh_term>
      <mesh_term>Communicable Diseases</mesh_term>
      <mesh_term>Respiratory Tract Infections</mesh_term>
      <mesh_term>Pseudomonas Infections</mesh_term>
      <mesh_term>Cystic Fibrosis</mesh_term>
      <mesh_term>Pulmonary Fibrosis</mesh_term>
      <mesh_term>Fibrosis</mesh_term>
      <mesh_term>Reinfection</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Tobramycin</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT06016088
  org study id: RESPIR-102
  nct id: NCT06016088
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  This dose escalation study will evaluate 4 doses of RSP-1502 in sequential cohorts of 8
        subjects each. In each cohort, 6 subjects will receive RSP-1502 and 2 will receive active
        control. Study drug (RSP-1502 or active control) will be administered by inhalation twice
        daily (BID) for 14 days. Planned RSP 1502 doses include 300 mg tobramycin plus ascending
        doses of CaEDTA (16 mg, 32 mg, 75 mg and 150 mg). Dose escalation will proceed after Safety
        Review Committee (SRC) review of the safety and tolerability data from the previous cohort.
        The SRC will determine the maximum tolerated dose (MTD) after completion of the fourth
        cohort. Following determination of the MTD, a fifth cohort (n = 20) will be randomized (1:1)
        to treatment with RSP 1502 (at the MTD) or active control administered BID for 14 days. All
        subjects will be followed for 14 days after completion of dosing.
  All Cohorts:
  
        Screening will occur within 35 days prior to Day 1. Informed consent will be obtained prior
        to any study procedures being performed. Eligibility assessments will be performed during
        screening.
  
        Cohorts 1 to 4: Treatment Period (Day 1 to Day 14 ± 2 days) Subjects will report to the
        testing facility on Day 1 for confirmation of eligibility. Baseline assessments and
        measurements will be performed prior to dosing and study assessments on Day 1. Subjects will
        be released from the testing facility following dosing and study assessments on Day 1.
        Subjects will return to the testing facility on Days 2 and 14 for study assessments; on these
        days, a dose of study drug will be administered in the testing facility. Study drug dosing
        will continue until the Day 14 visit.
  
        Cohort 5: Treatment Period (Day 1 to Day 14 ± 2 days) Subjects will report to the testing
        facility on Day 1 for confirmation of eligibility. Baseline assessments and measurements will
        be performed prior to dosing and study assessments on Day 1. Subjects will return to the
        testing facility on Day 14 for study assessments; on these days, a dose of study drug will be
        administered in the testing facility Study drug dosing will continue until the Day 14 visit.
  
        All Cohorts (including Cohort 5): Follow-Up Period (Day 15 to Day 28 ± 2 days):
  
        On Days 7 and 21, concomitant medications and adverse events (AEs) will be assessed via a
        phone call. Subjects will return to the testing facility on Day 28 for study assessments.
        Subjects will be discharged from the study on Day 28 after final assessments are performed.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Treatment-emergent adverse events
  time frame: Day 1 through Day 28
  measure: Treatment-emergent serious adverse events
  time frame: Day 1 through Day 28
  measure: Changes in post-dose spirometry
  time frame: Day 1, Day 2, and Day 14
  description: forced expiratory volume in 1 second
  measure: Pulmonary exacerbations
  time frame: Day 1 through Day 28
  description: a period of treatment with intravenous antibiotics in the hospital and/or at home
  measure: Changes in post-dose electrocardiogram results
  time frame: Day 1 and Day 2
  description: PR interval, QRS interval, QT interval
  measure: Pharmacokinetic parameters for CaEDTA
  time frame: Day 1
  description: Peak serum concentration (Cmax)
  measure: Pharmacokinetic parameters for CaEDTA
  time frame: Day 1 through Day 28
  description: Exposure (area under the serum concentration versus time curve [AUC])
  measure: Pharmacokinetic parameters for CaEDTA
  time frame: Day 1 through Day 28
  description: Time to maximum serum concentration (Tmax)
  measure: Pharmacokinetic parameters for tobramycin
  time frame: Day 1
  description: Peak serum concentration (Cmax)
  measure: Pharmacokinetic parameters for tobramycin
  time frame: Day 1 through Day 28
  description: Exposure (area under the serum concentration versus time curve [AUC])
  measure: Pharmacokinetic parameters for tobramycin
  time frame: Day 1
  description: Time to maximum serum concentration (Tmax)
  measure: Pharmacodynamic parameters
  time frame: Day 1, Day 14, and Day 28
  description: Inflammatory markers in sputum
  measure: Microbiology parameters
  time frame: Day 1 to Day 14; Day 1 to Day 28
  description: Change from baseline in Pseudomonas aeruginosa CFUs
  measure: Change from baseline in spirometry
  time frame: Day 1 to Day 28
  description: forced expiratory volume in 1 second (absolute change; change in % predicted)
  measure: Change from baseline in CFQ-R Respiratory Symptoms Score
  time frame: Day 1 to Day 28
  measure: Change from baseline in Chronic Respiratory Infection Symptom Score
  time frame: Day 1 to Day 28
  arm group label: RSP-1502
  arm group type: Experimental
  description: Each dose of RSP-1502 includes 300 mg tobramycin and an ascending dose of CaEDTA.
  Cohort 1: 300 mg tobramycin + 16 mg CaEDTA
  Cohort 2: 300 mg tobramycin + 32 mg CaEDTA
  Cohort 3: 300 mg tobramycin + 75 mg CaEDTA
  Cohort 4: 300 mg tobramycin + 150 mg CaEDTA Cohort 5 will receive 300 mg tobramycin + CaEDTA at the MTD.
  arm group label: Active Control
  arm group type: Active Comparator
  description: • Tobramycin Inhalation Solution 300 mg.
  intervention type: Drug
  intervention name: RSP-1502
  description: RSP 1502 is a sterile, preservative free solution to be administered by inhalation via a nebulizer. Each dose of RSP 1502 contains the active components tobramycin (60 mg/mL, 300 mg/vial) and CaEDTA. RSP 1502 contains Tromethamine USP (Tris), citric acid and sodium chloride as excipients. Additionally, sulfuric acid is used for pH adjustment.
  arm group label: RSP-1502
  intervention type: Drug
  intervention name: Tobramycin inhalation solution
  description: Tobramycin inhalation solution is 300 mg tobramycin in 5 mL solution.
  arm group label: Active Control
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Brian Jones, PhD
  phone: 215-732-5452
  email: bjones@respirionpharma.com
  last name: Tammy Abuan, MS
  phone: 206-595-3851
  email: tabuan@respirionpharma.com
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  country: Australia
  country: United States
  responsible party type: Sponsor
  mesh term: Infections
  mesh term: Communicable Diseases
  mesh term: Respiratory Tract Infections
  mesh term: Pseudomonas Infections
  mesh term: Cystic Fibrosis
  mesh term: Pulmonary Fibrosis
  mesh term: Fibrosis
  mesh term: Reinfection
  mesh term: Tobramycin
  sharing ipd: Undecided