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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 to day 14; day 1 to day 28

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 to day 14; day 1 to day 28

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes in post-dose electrocardiogram results

Changes in post-dose spirometry

Pulmonary exacerbations

+2 more

Secondary outcome measures

Pharmacokinetic parameters for CaEDTA

Pharmacokinetic parameters for tobramycin

Other outcome measures

Change from baseline in CFQ-R Respiratory Symptoms Score

Change from baseline in Chronic Respiratory Infection Symptom Score

Change from baseline in spirometry

+2 more

Side effects data

From 2015 Phase 4 trial • 45 Patients • NCT02178540

Bronchopneumonia

Pulmonary function test decreased

100%

80%

60%

40%

20%

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Respirion Pharmaceuticals Pty LtdLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals being recruited for this particular experiment at present?

"The information on clinicaltrials.gov indicates that this particular study is not presently enrolling patients. Initially posted in October of 2023, the last update to this trial was made in August of the same year. Fortunately, 1267 other trials are actively accepting participants at present time."

Answered by AI

In what areas is this medical trial being conducted?

"This study boasts participation from 15 different medical facilities, namely Keck Medical Center of USC in Los Angeles, Stanford University Medical Center in Palo Alto and Augusta University in Augusta, as well as a dozen other sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Double-Blind, Active-Controlled, Multiple-Ascending Dose Study of Aerosolized RSP-1502 in Subjects With CF and Chronic PA Lung Infection

2024. "A Double-Blind, Active-Controlled, Multiple-Ascending Dose Study of Aerosolized RSP-1502 in Subjects With CF and Chronic PA Lung Infection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06016088.

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