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Anti-infective agent

RSP-1502 Inhalation for Cystic Fibrosis

Phase 1 & 2
Recruiting
Research Sponsored by Respirion Pharmaceuticals Pty Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of CF based on 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
Male subjects must show documentation of infertility or agree to use condoms during study participation
Must not have
Currently taking other medications with known nephrotoxic, neurotoxic, or ototoxic potential
Currently taking ethacrynic acid, furosemide, urea, or intravenous mannitol
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to day 14; day 1 to day 28
Awards & highlights

Summary

This trial will test 4 doses of a drug (RSP-1502) to find the most effective and safe dose. Subjects will receive the drug or an active control & be monitored for safety & efficacy.

Who is the study for?
Adults over 18 with cystic fibrosis and chronic lung infection caused by P. aeruginosa, who haven't had significant respiratory symptoms or changes in their CF treatments for the past month. They must be able to avoid other inhaled antibiotics during the study and have a stable organ function as determined by tests. Women of childbearing age should use contraception, men should either be infertile or agree to use condoms.
What is being tested?
The trial is testing RSP-1502, an aerosolized drug combined with different doses of CaEDTA compared to Tobramycin inhalation solution. Participants will inhale their assigned treatment twice daily for two weeks while being monitored for safety and effectiveness. The best dose will be chosen based on tolerance levels observed across groups.
What are the potential side effects?
Potential side effects may include allergic reactions to components of RSP-1502, issues related to nephrotoxicity (kidney damage), neurotoxicity (nerve damage), or ototoxicity (hearing loss) due to medication ingredients similar to those found in some participants' excluded medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with CF based on tests and symptoms.
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I am a male and will use condoms or am infertile.
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My lung function, measured by FEV1, is between 40% and 90% of the expected value.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently on medication that could harm my kidneys, nerves, or hearing.
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I am currently taking medications like ethacrynic acid or furosemide.
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I am not pregnant, breastfeeding, or have a positive pregnancy test.
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I have a weakened immune system due to illness or organ transplant.
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My kidney function is low, or my liver tests are high.
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I need more than 10 mg of prednisone or a similar medication daily.
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I cannot produce sputum and do not want to undergo a procedure to induce it.
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I have active Hepatitis B or C.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to day 14; day 1 to day 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to day 14; day 1 to day 28 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Changes in post-dose electrocardiogram results
Changes in post-dose spirometry
Pulmonary exacerbations
Other study objectives
Change from baseline in spirometry
Microbiology parameters
Pharmacodynamic parameters

Side effects data

From 2015 Phase 4 trial • 45 Patients • NCT02178540
2%
Bronchopneumonia
2%
Pulmonary function test decreased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Total - All Participants
Open Label (11-17)Years Old
Open Label (6-10) Years Old
Open Label (>=18) Years Old

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: RSP-1502Experimental Treatment1 Intervention
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.
Group II: Active ControlActive Control1 Intervention
• Tobramycin Inhalation Solution 300 mg.

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Who is running the clinical trial?

Respirion Pharmaceuticals Pty LtdLead Sponsor
~26 spots leftby Apr 2025
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