Actively Recruiting
A Double-Blind, Active-Controlled, Multiple-Ascending Dose, Phase 1b/2a Study of Aerosolized RSP-1502 Delivered Via the PARI LC Plus® Nebulizer in Subjects With Cystic Fibrosis and Chronic Pseudomonas Aeruginosa Lung Infection
Led by Respirion Pharmaceuticals Pty Ltd · Updated on 2025-12-29
72
Participants Needed
22
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety of aerosolized RSP-1502, a drug containing tobramycin and CaEDTA, in people with cystic fibrosis who have chronic lung infections caused by Pseudomonas aeruginosa. This phase 1b/2a study compares different doses of RSP-1502 to an active control treatment to find the highest tolerated dose and assess safety. The study is double-blind, meaning neither participants nor researchers know who receives which treatment during the study. Participants will inhale RSP-1502 or the active control, which is tobramycin inhalation solution, over 14 days. The study includes dose escalation cohorts receiving increasing doses of RSP-1502 combined with a fixed dose of tobramycin, followed by a dose expansion cohort at the maximum tolerated dose (MTD). Treatments are delivered via a nebulizer device designed to administer the medication directly to the lungs. During the study, participants will undergo evaluations including spirometry tests, electrocardiograms, and monitoring for any adverse events from Day 1 through Day 28, which covers the 14 days of treatment and 14 days of follow-up after dosing. Researchers will also analyze drug levels in the body at various time points and monitor for lung exacerbations and safety signals. The total participation period is 28 days per participant.
CONDITIONS
Brief Title
A Double-Blind, Active-Controlled, Multiple-Ascending Dose Study of Aerosolized RSP-1502 in Subjects With CF and Chronic PA Lung Infection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females aged 18 years or older for cohorts 1-4; males or females aged 12 years or older for cohort 5.
- Diagnosis of cystic fibrosis confirmed by sweat chloride ≥ 60 mEq/L and/or genotype with two CF mutations plus clinical features.
- History of Pseudomonas aeruginosa-positive sputum cultures or throat swabs with at least 50% positive in the last 2 years.
- Positive sputum culture for Pseudomonas aeruginosa at screening.
- Forced expiratory volume in 1 second (FEV1) between 30% and 120% predicted.
- Ability to withhold all other inhaled tobramycin from 28 days before to 28 days after study participation and all other inhaled antibiotics from 14 days before to 28 days after.
- Medically stable without significant new or acute respiratory symptoms within 30 days before screening.
- Normal hematology, clinical chemistry, and urinalysis results without significant abnormalities at screening.
- Females of childbearing potential must agree to use effective contraception during the study.
- Males must document infertility or agree to use condoms during study participation.
- Ability to communicate, understand, and voluntarily sign informed consent and complete all study visits and procedures.
You will not qualify if you...
- Allergy or sensitivity to components of RSP-1502.
- Intolerance to inhaled tobramycin products.
- Reduced kidney function (eGFR < 40 mL/min) or elevated liver enzymes at screening.
- Taking medications known to be toxic to kidneys, nerves, or ears, except low-dose azithromycin under certain conditions.
- Taking ethacrynic acid, furosemide, urea, or intravenous mannitol.
- Lung infection with certain harmful organisms like Burkholderia species or Mycobacterium abscessus without confirmed clearance.
- Unable or unwilling to produce sputum samples.
- Recent respiratory infection or worsening lung disease needing treatment within 30 days before dosing.
- Recent changes in chronic airway medications or airway clearance treatments within 28 days before screening.
- Immunocompromised status or organ transplant.
- Need for high-dose systemic prednisone (>10 mg daily).
- Tobacco or substance vaping or smoking within 1 month before screening and inability to stop during the study.
- Pregnancy, lactation, or positive pregnancy test.
- HIV positive or active hepatitis B or C.
- History of recreational drug or alcohol abuse affecting compliance.
- Participation in another investigational drug study within 30 days or five half-lives prior.
- Any other medical condition that may risk safety or study validity as judged by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 14 days
Participants receive aerosolized RSP-1502 or active control by inhalation daily for 14 days to evaluate safety and dosage.
Daily visits for 14 days
Duration - 14 days
Participants are followed for 14 days after completion of dosing to monitor safety and health outcomes.
1 to 2 visits during follow-up period
Trial Site Locations
Total: 22 locations
1
Tucson Cystic Fibrosis Center
Tucson, Arizona, United States, 85750
Actively Recruiting
2
Center for Cystic Fibrosis at Keck Medical Center of USC
Los Angeles, California, United States, 90033
Actively Recruiting
3
Stanford University Medical Center
Palo Alto, California, United States, 94305
Actively Recruiting
4
Augusta University
Augusta, Georgia, United States, 30912
Actively Recruiting
5
The Cystic Fibrosis Institute
Northfield, Illinois, United States, 60093
Actively Recruiting
6
Tulane University
New Orleans, Louisiana, United States, 70118
Actively Recruiting
7
The Minnesota Cystic Fibrosis Center
Minneapolis, Minnesota, United States, 55403
Actively Recruiting
8
Washington University School of Medicine
St Louis, Missouri, United States, 63130
Actively Recruiting
9
Columbia University Cystic Fibrosis Program
New York, New York, United States, 10027
Actively Recruiting
10
Rainbow Babies and Children's Hospital / University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
11
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
12
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
13
Dell Children's Medical Center of Central Texas
Austin, Texas, United States, 78723
Actively Recruiting
14
Royal Prince Albert Hospital
Camperdown, New South Wales, Australia
Actively Recruiting
15
Westmead Hospital
Westmead, New South Wales, Australia
Actively Recruiting
16
Queensland Children's Hospital
Brisbane, Queensland, Australia
Actively Recruiting
17
The Prince Charles Hospital
Brisbane, Queensland, Australia
Actively Recruiting
18
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Actively Recruiting
19
The Alfred Hospital
Melbourne, Victoria, Australia
Actively Recruiting
20
The Royal Children's Hospital
Parkville, Victoria, Australia
Actively Recruiting
21
Lung Institute of Western Australia
Nedlands, Western Australia, Australia
Actively Recruiting
22
The Kids Research Institute Australia, Perth Children's Hospital
Perth, Western Australia, Australia
Actively Recruiting
Research Team
B
Brian Jones, PhD
S
Sarah Coquillette
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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