A Double-Blind, Active-Controlled, Multiple-Ascending Dose Study of Aerosolized RSP-1502 in Subjects With CF and Chronic PA Lung Infection
1 other identifier
interventional
72
2 countries
22
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2024
Typical duration for phase_1
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 21, 2023
CompletedFirst Posted
Study publicly available on registry
August 29, 2023
CompletedStudy Start
First participant enrolled
April 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
ExpectedDecember 29, 2025
December 1, 2025
2 years
August 21, 2023
December 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Treatment-emergent adverse events
Day 1 through Day 28
Treatment-emergent serious adverse events
Day 1 through Day 28
Changes in post-dose spirometry
Forced expiratory volume in 1 second
Day 1, Day 2, and Day 14
Pulmonary exacerbations
A period of treatment with intravenous antibiotics in the hospital and/or at home
Day 1 through Day 28
Changes in post-dose electrocardiogram results
PR interval, QRS interval, QT interval
Day 1, Day 2, and Day 14
Secondary Outcomes (2)
Pharmacokinetic parameters for CaEDTA
Day 1, Day 2, Day 14, and Day 28
Pharmacokinetic parameters for tobramycin
Day 1, Day 2, Day 14, and Day 28
Other Outcomes (5)
Pharmacodynamic parameters
Day 1, Day 14, and Day 28
Microbiology parameters
Day 1 to Day 14; Day 1 to Day 28
Change from baseline in spirometry
Day 1 to Day 28
- +2 more other outcomes
Study Arms (2)
RSP-1502
EXPERIMENTALCohorts 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.
Active Control
ACTIVE COMPARATOR• Tobramycin Inhalation Solution 300 mg.
Interventions
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.
Tobramycin inhalation solution is 300 mg tobramycin in 5 mL solution.
Eligibility Criteria
You may qualify if:
- Males or females aged ≥18 years of age for cohorts 1-4; males or females ≥12 years of age for cohort 5.
- 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 2 years preceding screening.
- P. aeruginosa-positive sputum culture at screening.
- Forced expiratory volume in 1 second (FEV1) ≥ 30 and ≤ 120% 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, and be capable and willing to complete all study visits and perform all study required procedures.
You may not qualify if:
- 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 total 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 (subjects receiving inhaled tobramycin in conjunction with low dose azithromycin prior to study participation without evidence of ototoxicity may continue taking low dose azithromycin during the study).
- 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:
- The subject has not had a respiratory tract culture positive for these organisms within the 12 months before the date of informed consent.
- 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 acute upper or lower respiratory tract infection or pulmonary exacerbation requiring changes in therapy (including systemic antibiotics), or other 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.
- Vaping or smoking tobacco or any other substance within 1 month prior to screening and anticipated inability to refrain from vaping or smoking throughout the study.
- Female subjects who are pregnant, lactating, or have a positive urine human chorionic gonadotropin (pregnancy) test, as determined by laboratory testing.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Tucson Cystic Fibrosis Center
Tucson, Arizona, 85750, United States
Center for Cystic Fibrosis at Keck Medical Center of USC
Los Angeles, California, 90033, United States
Stanford University Medical Center
Palo Alto, California, 94305, United States
Augusta University
Augusta, Georgia, 30912, United States
The Cystic Fibrosis Institute
Northfield, Illinois, 60093, United States
Tulane University
New Orleans, Louisiana, 70118, United States
The Minnesota Cystic Fibrosis Center
Minneapolis, Minnesota, 55403, United States
Washington University School of Medicine
St Louis, Missouri, 63130, United States
Columbia University Cystic Fibrosis Program
New York, New York, 10027, United States
Rainbow Babies and Children's Hospital / University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Dell Children's Medical Center of Central Texas
Austin, Texas, 78723, United States
Royal Prince Albert Hospital
Camperdown, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Queensland Children's Hospital
Brisbane, Queensland, Australia
The Prince Charles Hospital
Brisbane, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
The Royal Children's Hospital
Parkville, Victoria, Australia
Lung Institute of Western Australia
Nedlands, Western Australia, Australia
The Kids Research Institute Australia, Perth Children's Hospital
Perth, Western Australia, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2023
First Posted
August 29, 2023
Study Start
April 1, 2024
Primary Completion
April 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
December 29, 2025
Record last verified: 2025-12