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
Respirion Pharmaceuticals Pty Ltd
Summary
A double-blind, active-controlled, multiple-ascending dose, safety study of aerosolized RSP-1502 in subjects with cystic fibrosis Pseudomonas aeruginosa lung infection.
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.
Eligibility
- Age range
- 12+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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)…
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 CenterTucson, Arizona
- Center for Cystic Fibrosis at Keck Medical Center of USCLos Angeles, California
- Stanford University Medical CenterPalo Alto, California
- Augusta UniversityAugusta, Georgia
- The Cystic Fibrosis InstituteNorthfield, Illinois
- Tulane UniversityNew Orleans, Louisiana