Cystic Fibrosis LungPhase 1/2NCT06016088
A Double-Blind, Active-Controlled, Multiple-Ascending Dose Study of Aerosolized RSP-1502 in Subjects With CF and Chronic PA Lung Infection
A Phase 1/2 study testing RSP-1502 and Tobramycin inhalation solution in people with Cystic Fibrosis Lung and Respiratory Infections, Recurrent, Chronic, run by Respirion Pharmaceuticals Pty Ltd at 22 sites in 2 countries.
Trial summary
A double-blind, active-controlled, multiple-ascending dose, safety study of aerosolized RSP-1502 in subjects with cystic fibrosis Pseudomonas aeruginosa lung infection. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Cystic Fibrosis Lung, Respiratory Infections, Recurrent, Chronic, Pseudomonas Aeruginosa
- What is being tested?
- RSP-1502 and Tobramycin inhalation solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 22 sitesin 2 countries
- Study dates
- 1 Apr 2024to 22 Jun 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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:
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- 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.
- 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.
- Has any other medical condition(s) which, in the opinion of the Principal Investigator, would jeopardize the safety of the study subject or impact the validity of the study results.
Trial locations and contacts
22 sites in 2 countries.
22 sites in 2 countries
United States13 sites
Augusta University
Augusta, Georgia, 30912
Dell Children's Medical Center of Central Texas
Austin, Texas, 78723
Rainbow Babies and Children's Hospital / University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Nationwide Children's Hospital
Columbus, Ohio, 43205
Center for Cystic Fibrosis at Keck Medical Center of USC
Los Angeles, California, 90033
The Minnesota Cystic Fibrosis Center
Minneapolis, Minnesota, 55403
Tulane University
New Orleans, Louisiana, 70118
Columbia University Cystic Fibrosis Program
New York, New York, 10027
The Cystic Fibrosis Institute
Northfield, Illinois, 60093
Stanford University Medical Center
Palo Alto, California, 94305
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Washington University School of Medicine
St Louis, Missouri, 63130
Tucson Cystic Fibrosis Center
Tucson, Arizona, 85750
Australia9 sites
Royal Adelaide Hospital
Adelaide, South Australia
Queensland Children's Hospital
Brisbane, Queensland
The Prince Charles Hospital
Brisbane, Queensland
Royal Prince Albert Hospital
Camperdown, New South Wales
The Alfred Hospital
Melbourne, Victoria
Lung Institute of Western Australia
Nedlands, Western Australia
The Royal Children's Hospital
Parkville, Victoria
The Kids Research Institute Australia, Perth Children's Hospital
Perth, Western Australia
Westmead Hospital
Westmead, New South Wales
About this study
Official title: 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
A double-blind, active-controlled, multiple-ascending dose, safety study of aerosolized RSP-1502 in subjects with cystic fibrosis Pseudomonas aeruginosa lung infection.
Read the 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.
- Being tested
- RSP-1502, Tobramycin inhalation solution
- Keywords
- Pseudomonas aeruginosa, cystic fibrosis, pulmonary infection, tobramycin, lung infection, EDTA, edetate calcium disodium
- Medical subject headings
- Cystic Fibrosis, Respiratory Tract Infections, Recurrence, Bronchiolitis Obliterans Syndrome, Pseudomonas Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RSP-1502Drug
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 solutionDrug
Tobramycin inhalation solution is 300 mg tobramycin in 5 mL solution.
| Study group | Role | What they receive |
|---|---|---|
| RSP-1502 | Experimental | 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. Receives: Drug: RSP-1502 |
| Active Control | Active comparator | • Tobramycin Inhalation Solution 300 mg. Receives: Drug: Tobramycin inhalation solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-emergent adverse events
Measured: Day 1 through Day 28
Treatment-emergent serious adverse events
Measured: Day 1 through Day 28
Changes in post-dose spirometry
Forced expiratory volume in 1 second
Measured: Day 1, Day 2, and Day 14
Pulmonary exacerbations
A period of treatment with intravenous antibiotics in the hospital and/or at home
Measured: Day 1 through Day 28
Changes in post-dose electrocardiogram results
PR interval, QRS interval, QT interval
Measured: Day 1, Day 2, and Day 14
Secondary outcomes (2)
Pharmacokinetic parameters for CaEDTA
Measured: Day 1, Day 2, Day 14, and Day 28
Pharmacokinetic parameters for tobramycin
Measured: Day 1, Day 2, Day 14, and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start1 Apr 2024
- Primary completion15 Apr 2026
- Study completion22 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic Fibrosis LungStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Respirion Pharmaceuticals Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06016088
- Sponsor's protocol ID
- RESPIR-102
- Status last verified
- Jun 2026
- First submitted
- 21 Aug 2023
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06016088
- Acronym / sponsor ID
- RESPIR-102
- Keywords
- Pseudomonas aeruginosa, cystic fibrosis, pulmonary infection, tobramycin, lung infection, EDTA, edetate calcium disodium
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Respirion Pharmaceuticals Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 22 Jun 2026 (actual)
- First posted
- 29 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A double-blind, active-controlled, multiple-ascending dose, safety study of aerosolized RSP-1502 in subjects with cystic fibrosis Pseudomonas aeruginosa lung infection.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RSP-1502 | Experimental | Drug: RSP-1502Cohorts 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 | Drug: Tobramycin inhalation solution• Tobramycin Inhalation Solution 300 mg. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RSP-1502RSP-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. | Drug | RSP-1502 |
| Tobramycin inhalation solutionTobramycin inhalation solution is 300 mg tobramycin in 5 mL solution. | Drug | Active Control |
Primary outcome
Treatment-emergent adverse events
Time frame: Day 1 through Day 28
Treatment-emergent serious adverse events
Time frame: Day 1 through Day 28
Changes in post-dose spirometry
Time frame: Day 1, Day 2, and Day 14
Forced expiratory volume in 1 second
Pulmonary exacerbations
Time frame: Day 1 through Day 28
A period of treatment with intravenous antibiotics in the hospital and/or at home
Changes in post-dose electrocardiogram results
Time frame: Day 1, Day 2, and Day 14
PR interval, QRS interval, QT interval
2 secondary outcomes
Pharmacokinetic parameters for CaEDTA
Time frame: Day 1, Day 2, Day 14, and Day 28
Pharmacokinetic parameters for tobramycin
Time frame: Day 1, Day 2, Day 14, and Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
22 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing RSP-1502 and Tobramycin inhalation solution in people with Cystic Fibrosis Lung and Respiratory Infections, Recurrent, Chronic, run by Respirion Pharmaceuticals Pty Ltd at 22 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-emergent adverse events (time frame: Day 1 through Day 28). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.