RECRUITING

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

Conditions

Cystic Fibrosis Lung Respiratory Infections, Recurrent, Chronic Pseudomonas Aeruginosa cystic fibrosis pulmonary infection tobramycin lung infection EDTA edetate calcium disodium

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A Double-Blind, Active-Controlled, Multiple-Ascending Dose, Phase 1b Study of Aerosolized RSP-1502 Delivered Via the PARI LC Plus® Nebulizer in Subjects With Cystic Fibrosis and Chronic Pseudomonas Aeruginosa Lung Infection

Quick Facts

Study Start:2024-04-01

Study Completion:2025-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06016088

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Males or females aged ≥18 years of age. * 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 year preceding screening. * P. aeruginosa-positive sputum culture at screening. * Forced expiratory volume in 1 second (FEV1) ≥ 40 and ≤ 90% 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. * 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.	* 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 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. * 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: 1. The subject has not had a respiratory tract culture positive for these organisms within the 12 months before the date of informed consent. 2. 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 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. * Smoking or vaping tobacco or any substance within 6 months prior to screening and anticipated inability to refrain from smoking throughout the study. * Female subjects who are pregnant, lactating, or have a positive serum 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.

Inclusion Criteria

Exclusion Criteria

* Males or females aged ≥18 years of age.
* 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 year preceding screening.
* P. aeruginosa-positive sputum culture at screening.
* Forced expiratory volume in 1 second (FEV1) ≥ 40 and ≤ 90% 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.
* 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.

* 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 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.
* 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:
1. The subject has not had a respiratory tract culture positive for these organisms within the 12 months before the date of informed consent.
2. 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 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.
* Smoking or vaping tobacco or any substance within 6 months prior to screening and anticipated inability to refrain from smoking throughout the study.
* Female subjects who are pregnant, lactating, or have a positive serum 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.

Contacts and Locations

Study Contact

Brian Jones, PhD

CONTACT

215-732-5452

bjones@respirionpharma.com

Sarah Coquillette

CONTACT

scoquillette@respirionpharma.com

Study Locations (Sites)

Tucson Cystic Fibrosis Center

Tucson, Arizona, 85750

United States

Center for Cystic Fibrosis at Keck Medical Center of USC

Los Angeles, California, 90033

United States

Stanford University Medical Center

Palo Alto, California, 94305

United States

Augusta University

Augusta, Georgia, 30912

United States

Tulane University

New Orleans, Louisiana, 70118

United States

The Minnesota Cystic Fibrosis Center

Minneapolis, Minnesota, 55403

United States

Washington University School of Medicine

Saint Louis, Missouri, 63130

United States

Columbia University Cystic Fibrosis Program

New York, New York, 10027

United States

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

Cleveland, Ohio, 44106

United States

Nationwide Children's Hospital

Columbus, Ohio, 43205

United States

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

Dell Children's Medical Center of Central Texas

Austin, Texas, 78723

United States

Collaborators and Investigators

Sponsor: Respirion Pharmaceuticals Pty Ltd

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-01

Study Completion Date2025-04

Study Record Updates

Study Start Date2024-04-01

Study Completion Date2025-04

Terms related to this study

Keywords Provided by Researchers

Pseudomonas aeruginosa
cystic fibrosis
pulmonary infection
tobramycin
lung infection
EDTA
edetate calcium disodium

Additional Relevant MeSH Terms

Cystic Fibrosis Lung
Respiratory Infections, Recurrent, Chronic
Pseudomonas Aeruginosa