Actively Recruiting
A Double-Blind, Active-Controlled, Multiple-Ascending Dose Study of Aerosolized RSP-1502 in Subjects With CF and Chronic PA Lung Infection
Led by Respirion Pharmaceuticals Pty Ltd · Updated on 2025-12-29
72
Participants Needed
22
Research Sites
113 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A double-blind, active-controlled, multiple-ascending dose, safety study of aerosolized RSP-1502 in subjects with cystic fibrosis Pseudomonas aeruginosa lung infection.
CONDITIONS
Official 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 value ≥ 60 mEq/L or genotype with two CF mutations and clinical features
- History of Pseudomonas aeruginosa-positive sputum cultures or throat swabs with at least 50% positive in the past 2 years
- Pseudomonas aeruginosa-positive sputum culture at screening
- Forced expiratory volume in 1 second (FEV1) between 30% and 120% predicted, pre- or post-bronchodilator
- Ability to withhold all other inhaled tobramycin from Day -28 to Day 28 and all other inhaled antibiotics from Day -14 to Day 28
- Medically stable with no significant new or acute respiratory symptoms within 30 days prior to screening
- Hematology, clinical chemistry, and urinalysis results without clinically significant abnormalities at screening
- Female subjects of childbearing potential must agree to use effective contraception from screening through Day 28
- Male subjects must show documentation of infertility or agree to use condoms during study participation
- Ability to communicate with site personnel, understand and sign informed consent, and complete all study visits and procedures
You will not qualify if you...
- History of allergy or sensitivity to components of RSP-1502
- History of intolerance to inhaled tobramycin products
- eGFR less than 40 mL/min, or serum total bilirubin more than twice normal, or serum transaminases more than three times normal at screening
- Currently taking medications with known nephrotoxic, neurotoxic, or ototoxic potential (except low dose azithromycin prior to study without ototoxicity)
- Currently taking ethacrynic acid, furosemide, urea, or intravenous mannitol
- Lung infection with organisms linked to rapid pulmonary decline (e.g., Burkholderia cenocepacia, Burkholderia dolosa, Mycobacterium abscessus) unless criteria confirm infection-free status
- Consistent inability or unwillingness to produce sputum or perform sputum induction
- Any acute respiratory infection or pulmonary exacerbation requiring therapy changes within 30 days prior to first drug administration
- Recent initiation or adjustment of chronic airway medications or airway clearance treatments within 28 days prior to screening
- Immunocompromised status due to illness or organ transplant
- Requires systemic prednisone over 10 mg daily
- Vaping or smoking tobacco or other substances within 1 month prior to screening and unable to refrain during study
- Pregnant, lactating, or positive pregnancy test
- HIV positive
- Active Hepatitis B or C
- History of drug or alcohol abuse compromising compliance
- Participation in another investigational drug study within 30 days or five half-lives of prior drug
- Any other medical condition that would jeopardize safety or study validity
AI-Screening
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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
CONTACT
S
Sarah Coquillette
CONTACT
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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