RecruitingPhase 1Phase 2NCT06016088

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

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

Sponsor

Respirion Pharmaceuticals Pty Ltd

Enrollment

72 participants

Start Date

Apr 1, 2024

Study Type

INTERVENTIONAL

Conditions

Pseudomonas aeruginosa Cystic Fibrosis Lung Respiratory Infections, Recurrent, Chronic

Summary

A double-blind, active-controlled, multiple-ascending dose, safety study of aerosolized RSP-1502 in subjects with cystic fibrosis Pseudomonas aeruginosa lung infection.

Eligibility

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called RSP-1502 and a drug called Tobramycin inhalation solution for people with cystic fibrosis lung, pseudomonas aeruginosa, and other related conditions. The study is currently recruiting participants at 22 locations. People eligible for this study include aged 12 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRSP-1502

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.

DRUGTobramycin inhalation solution

Tobramycin inhalation solution is 300 mg tobramycin in 5 mL solution.

Locations(22)

Tucson Cystic Fibrosis Center

Tucson, Arizona, United States

Center for Cystic Fibrosis at Keck Medical Center of USC

Los Angeles, California, United States

Stanford University Medical Center

Palo Alto, California, United States

Augusta University

Augusta, Georgia, United States

The Cystic Fibrosis Institute

Northfield, Illinois, United States

Tulane University

New Orleans, Louisiana, United States

The Minnesota Cystic Fibrosis Center

Minneapolis, Minnesota, United States

Washington University School of Medicine

St Louis, Missouri, United States

Columbia University Cystic Fibrosis Program

New York, New York, United States

Rainbow Babies and Children's Hospital / University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Dell Children's Medical Center of Central Texas

Austin, Texas, United States

Royal Prince Albert Hospital

Camperdown, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

Queensland Children's Hospital

Brisbane, Queensland, Australia

The Prince Charles Hospital

Brisbane, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

The Royal Children's Hospital

Parkville, Victoria, Australia

Lung Institute of Western Australia

Nedlands, Western Australia, Australia

The Kids Research Institute Australia, Perth Children's Hospital

Perth, Western Australia, Australia

View Full Details on ClinicalTrials.gov

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NCT06016088

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