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A Double-Blind, Active-Controlled, Multiple-Ascending Dose Study of Aerosolized RSP-1502 in Subjects With CF and Chronic PA Lung Infection

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ClinicalTrials.gov Identifier: NCT06016088
Recruitment Status : Recruiting
First Posted : August 29, 2023
Last Update Posted : April 22, 2024
Sponsor:
Information provided by (Responsible Party):
Respirion Pharmaceuticals Pty Ltd

Study Description
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Brief Summary:
A double-blind, active-controlled, multiple-ascending dose, safety study of aerosolized RSP-1502 in subjects with cystic fibrosis Pseudomonas aeruginosa lung infection.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Lung Respiratory Infections, Recurrent, Chronic Pseudomonas Aeruginosa Drug: RSP-1502 Drug: Tobramycin inhalation solution Phase 1 Phase 2

Detailed Description:
This dose escalation safety study will evaluate several doses of RSP-1502 or active control administered by inhalation for 14 days. Following determination of the MTD, a dose expansion cohort will receive RSP-1502 at the MTD versus active control administered by inhalation for 14 days. All subjects will be followed for 14 days after completion of dosing.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : April 1, 2024
Estimated Primary Completion Date : April 2025
Estimated Study Completion Date : April 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arms and Interventions
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Arm Intervention/treatment
Experimental: RSP-1502

Cohorts 1-4 will receive RSP-1502 (300 mg tobramycin plus an ascending dose of CaEDTA).

Cohort 5 will receive 300 mg tobramycin + CaEDTA at the MTD.

 Drug: RSP-1502
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 (300 mg) and CaEDTA in a 5 mL solution.
Active Comparator: Active Control
• Tobramycin Inhalation Solution 300 mg.
 Drug: Tobramycin inhalation solution
Tobramycin inhalation solution is 300 mg tobramycin in 5 mL solution.


Outcome Measures
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Primary Outcome Measures :
  1. Treatment-emergent adverse events [ Time Frame: Day 1 through Day 28 ]
  2. Treatment-emergent serious adverse events [ Time Frame: Day 1 through Day 28 ]
  3. Changes in post-dose spirometry [ Time Frame: Day 1, Day 2, and Day 14 ]
    Forced expiratory volume in 1 second

  4. Pulmonary exacerbations [ Time Frame: Day 1 through Day 28 ]
    A period of treatment with intravenous antibiotics in the hospital and/or at home

  5. Changes in post-dose electrocardiogram results [ Time Frame: Day 1 and Day 2 ]
    PR interval, QRS interval, QT interval


Secondary Outcome Measures :
  1. Pharmacokinetic parameters for CaEDTA [ Time Frame: Day 1 ]
  2. Pharmacokinetic parameters for tobramycin [ Time Frame: Day 1 ]

Other Outcome Measures:
  1. Pharmacodynamic parameters [ Time Frame: Day 1, Day 14, and Day 28 ]
    Biomarkers in sputum

  2. Microbiology parameters [ Time Frame: Day 1 to Day 14; Day 1 to Day 28 ]
    Change from baseline in Pseudomonas aeruginosa CFUs

  3. Change from baseline in spirometry [ Time Frame: Day 1 to Day 28 ]
    Forced expiratory volume in 1 second (absolute change; change in % predicted)

  4. Change from baseline in CFQ-R Respiratory Symptoms Score [ Time Frame: Day 1 to Day 28 ]
  5. Change from baseline in Chronic Respiratory Infection Symptom Score [ Time Frame: Day 1 to Day 28 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males or females aged ≥18 years of age.
  • Diagnosis of CF based on the following: historical positive sweat chloride value ≥ 60 mEq/L, and/or genotype with two identifiable mutations consistent with CF, accompanied by one or more clinical features consistent with the CF phenotype.
  • History of P. aeruginosa-positive sputum cultures or throat swabs with at least 50% positive in the year preceding screening.
  • P. aeruginosa-positive sputum culture at screening.
  • Forced expiratory volume in 1 second (FEV1) ≥ 40 and ≤ 90% predicted per Global Lung Function Initiative (GLI) equation, pre- or post-bronchodilator.
  • Must be able to withhold all other inhaled tobramycin from Day 28 to Day 28 of study participation. Must be able to withhold all other inhaled antibiotics from Day -14 to Day 28.
  • Medically stable with no evidence of significant new or acute respiratory symptoms within 30 days prior to screening.
  • Hematology, clinical chemistry, and urinalysis results with no clinically significant abnormalities that would interfere with the study assessments at screening as determined by the investigator.
  • Female subjects of childbearing potential, defined as not surgically sterile or at least 2 years postmenopausal, must agree to use one of the following forms of contraception from screening through the Day 28 visit: hormonal (oral, implant, or injection) begun > 30 days prior to screening, barrier (condom, diaphragm with spermicide), intrauterine device, or vasectomized partner (6 months minimum).
  • Male subjects must show documentation of infertility or agree to use condoms during study participation.
  • Must be able to communicate with site personnel and to understand and voluntarily sign the Informed Consent Form.

Exclusion Criteria:

  • A history of previous allergy or sensitivity to components of RSP 1502.
  • A history of intolerance to inhaled tobramycin (TOBI®, BETHKIS®, TOBI® Podhaler®, tobramycin inhalation solution).
  • eGFR < 40 mL/min, or serum bilirubin > 2X or serum transaminases > 3X the upper limit of normal range at screening.
  • Currently taking other medications with known nephrotoxic, neurotoxic, or ototoxic potential.
  • Currently taking ethacrynic acid, furosemide, urea, or intravenous mannitol.

  • Lung infection with organisms associated with a more rapid decline in pulmonary status (including, but not limited to, Burkholderia cenocepacia, Burkholderia dolosa, and Mycobacterium abscessus). For subjects who have had a history of a positive culture, the investigator will apply the following criteria to establish whether the subject is free of infection with such organisms:

    1. The subject has not had a respiratory tract culture positive for these organisms within the 12 months before the date of informed consent.
    2. The subject has had at least 2 respiratory tract cultures negative for such organisms within the 12 months before the date of informed consent, with the first and last of these separated by at least 3 months, and the most recent one within the 6 months before the date of informed consent.
  • Consistent inability to produce sputum and unwillingness to perform sputum induction.
  • Any significant clinical/laboratory/radiological/spirometric sign of unstable or unexpectedly deteriorating respiratory disease within 30 days prior to the first study drug administration.
  • Initiation or adjustment of chronic airway medications (eg, inhaled corticosteroids; chronic suppressive antibacterial treatment) or airway clearance regimen (eg, nebulized saline, rhDNase, initiation of mechanical vest or handheld airway clearance device) within 28 days prior to screening. Individuals can be rescreened 28 days after these agents/therapies have been established for at least 28 days.
  • Is immunocompromised due to illness, or solid or hematological organ transplant.
  • Requires systemic prednisone (or equivalent) > 10 mg daily.
  • Smoking or vaping tobacco or any substance within 6 months prior to screening and anticipated inability to refrain from smoking throughout the study.
  • Female subjects who are pregnant, lactating, or have a positive serum human chorionic gonadotropin (pregnancy) test, as determined by laboratory testing.
  • HIV positive.
  • Active Hepatitis B or C.
  • History of recreational drug or alcohol use/abuse which in the opinion of the investigator will compromise the patient's ability to comply with the study protocol.
  • Participation in a clinical study with administration of an investigational drug product within the previous 30 days, or five half-lives of the previously administered investigational product.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06016088


Contacts
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Contact: Brian Jones, PhD 215-732-5452 bjones@respirionpharma.com
Contact: Sarah Coquillette scoquillette@respirionpharma.com

Locations
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United States, Arizona
Tucson Cystic Fibrosis Center Recruiting
Tucson, Arizona, United States, 85750
Contact: Elizabeth Ryan       elizabethryan@arizona.edu   
Principal Investigator: Cori Daines, MD         
United States, California
Center for Cystic Fibrosis at Keck Medical Center of USC Not yet recruiting
Los Angeles, California, United States, 90033
Contact: Lynn Fukushima       lynn.fukushima@med.usc.edu   
Principal Investigator: Adupa Rao, MD         
Stanford University Medical Center Recruiting
Palo Alto, California, United States, 94305
Contact: Amanda Keen       ajkeen@stanford.edu   
Principal Investigator: Carlos Milla, MD         
United States, Georgia
Augusta University Recruiting
Augusta, Georgia, United States, 30912
Contact: Heidi Stapp       hstapp@augusta.edu   
Principal Investigator: Caralee Forseen, MD         
United States, Louisiana
Tulane University Not yet recruiting
New Orleans, Louisiana, United States, 70118
Contact: Carol Rockwell       crockwell@tulane.edu   
Principal Investigator: Ross Klingsberg, MD         
United States, Minnesota
The Minnesota Cystic Fibrosis Center Recruiting
Minneapolis, Minnesota, United States, 55403
Contact: Mary Bailey       cftrials@umn.edu   
Principal Investigator: Kathleen Mahan, MD         
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63130
Contact: Taylor Haas       koenigt@wustl.edu   
Principal Investigator: Daniel Rosenbluth, MD         
United States, New York
Columbia University Cystic Fibrosis Program Recruiting
New York, New York, United States, 10027
Contact: Cayla Boodram       cpb2164@cumc.columbia.edu   
Principal Investigator: Claire Keating, MD         
United States, Ohio
Rainbow Babies and Children's Hospital / University Hospitals Cleveland Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Cindy Schaefer       cindy.schaefer@uhhospitals.org   
Principal Investigator: Alex Gifford, MD         
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Terri Johnson       terri.johnson@nationwidechildrens.org   
Principal Investigator: Karen McCoy, MD         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Kishan Patel       kishan.patel1@pennmedicine.upenn.edu   
Principal Investigator: Daniel Dorgan, MD         
United States, Texas
Dell Children's Medical Center of Central Texas Not yet recruiting
Austin, Texas, United States, 78723
Contact: Kristina Adrean       kadrean@ascension.org   
Principal Investigator: Jason Fulmer, MD         
Australia, New South Wales
The Alfred Hospital Recruiting
Camperdown, New South Wales, Australia
Contact: Peter Wark, Prof.       Peter.Wark@hnehealth.nsw.gov.au   
Westmead Hospital Recruiting
Westmead, New South Wales, Australia
Contact: Tracey Burns       tracey.burns@health.nsw.gov.au   
Australia, South Australia
Royal Adelaide Hospital Recruiting
Adelaide, South Australia, Australia
Contact: Judith Morton, Prof.       judith.morton@sa.gov.au   
Australia, Western Australia
Lung Institute of Western Australia Recruiting
Nedlands, Western Australia, Australia
Contact: Siobhain Mulrennan, Prof.       admin@resphealth.uwa.edu.au   
Sponsors and Collaborators
Respirion Pharmaceuticals Pty Ltd
More Information
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Responsible Party: Respirion Pharmaceuticals Pty Ltd
ClinicalTrials.gov Identifier: NCT06016088    
Other Study ID Numbers: RESPIR-102
First Posted: August 29, 2023    Key Record Dates
Last Update Posted: April 22, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Respirion Pharmaceuticals Pty Ltd:
Pseudomonas aeruginosa
cystic fibrosis
pulmonary infection
tobramycin
 lung infection
EDTA
edetate calcium disodium
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Respiratory Tract Infections
Pseudomonas Infections
Cystic Fibrosis
Pulmonary Fibrosis
Fibrosis
Reinfection
Disease Attributes
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
 Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Gram-Negative Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Lung Diseases, Interstitial
Recurrence
Tobramycin
Anti-Bacterial Agents
Anti-Infective Agents