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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06016088
Registration number
NCT06016088
Ethics application status
Date submitted
21/08/2023
Date registered
29/08/2023
Date last updated
29/06/2025
Titles & IDs
Public title
A Double-Blind, Active-Controlled, Multiple-Ascending Dose Study of Aerosolized RSP-1502 in Subjects With CF and Chronic PA Lung Infection
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Scientific title
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
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Secondary ID [1]
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RESPIR-102
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis Lung
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Respiratory Infections, Recurrent, Chronic
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Pseudomonas Aeruginosa
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Condition category
Condition code
Infection
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Studies of infection and infectious agents
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Infection
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Other infectious diseases
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Infection
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Sexually transmitted infections
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Respiratory
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Other respiratory disorders / diseases
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Human Genetics and Inherited Disorders
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Cystic fibrosis
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Inflammatory and Immune System
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Connective tissue diseases
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - RSP-1502
Treatment: Drugs - Tobramycin inhalation solution
Experimental: RSP-1502 - 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.
Active comparator: Active Control - • Tobramycin Inhalation Solution 300 mg.
Treatment: Drugs: RSP-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.
Treatment: Drugs: Tobramycin inhalation solution
Tobramycin inhalation solution is 300 mg tobramycin in 5 mL solution.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Treatment-emergent adverse events
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Assessment method [1]
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Timepoint [1]
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Day 1 through Day 28
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Primary outcome [2]
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Treatment-emergent serious adverse events
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Assessment method [2]
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Timepoint [2]
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Day 1 through Day 28
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Primary outcome [3]
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Changes in post-dose spirometry
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Assessment method [3]
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Forced expiratory volume in 1 second
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Timepoint [3]
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Day 1, Day 2, and Day 14
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Primary outcome [4]
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Pulmonary exacerbations
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Assessment method [4]
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A period of treatment with intravenous antibiotics in the hospital and/or at home
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Timepoint [4]
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Day 1 through Day 28
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Primary outcome [5]
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Changes in post-dose electrocardiogram results
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Assessment method [5]
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PR interval, QRS interval, QT interval
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Timepoint [5]
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Day 1, Day 2, and Day 14
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Secondary outcome [1]
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Pharmacokinetic parameters for CaEDTA
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Assessment method [1]
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Timepoint [1]
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Day 1, Day 2, Day 14, and Day 28
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Secondary outcome [2]
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Pharmacokinetic parameters for tobramycin
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Assessment method [2]
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Timepoint [2]
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Day 1, Day 2, Day 14, and Day 28
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Eligibility
Key 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 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, and be capable and willing to complete all study visits and perform all study required procedures.
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Minimum age
12
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* 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 total 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 (subjects receiving inhaled tobramycin in conjunction with low dose azithromycin prior to study participation without evidence of ototoxicity may continue taking low dose azithromycin during the study).
* 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 acute upper or lower respiratory tract infection or pulmonary exacerbation requiring changes in therapy (including systemic antibiotics), or other 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.
* Vaping or smoking tobacco or any other substance within 1 month prior to screening and anticipated inability to refrain from vaping or smoking throughout the study.
* Female subjects who are pregnant, lactating, or have a positive urine 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.
* Has any other medical condition(s) which, in the opinion of the Principal Investigator, would jeopardize the safety of the study subject or impact the validity of the study results.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2025
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Actual
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Sample size
Target
72
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Royal Prince Albert Hospital - Camperdown
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Recruitment hospital [2]
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Westmead Hospital - Westmead
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Recruitment hospital [3]
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Queensland Children's Hospital - Brisbane
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Recruitment hospital [4]
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The Prince Charles Hospital - Brisbane
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Recruitment hospital [5]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [6]
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The Alfred Hospital - Melbourne
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Recruitment hospital [7]
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The Royal Children's Hospital - Parkville
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Recruitment hospital [8]
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Lung Institute of Western Australia - Nedlands
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Recruitment hospital [9]
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The Kids Research Institute Australia, Perth Children's Hospital - Perth
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Recruitment postcode(s) [1]
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- Camperdown
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Recruitment postcode(s) [2]
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- Westmead
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Recruitment postcode(s) [3]
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- Brisbane
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Recruitment postcode(s) [4]
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- Adelaide
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Recruitment postcode(s) [5]
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- Melbourne
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Recruitment postcode(s) [6]
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- Parkville
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Recruitment postcode(s) [7]
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- Nedlands
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Recruitment postcode(s) [8]
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- Perth
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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Country [2]
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United States of America
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State/province [2]
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California
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Country [3]
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United States of America
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State/province [3]
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Georgia
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Country [4]
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United States of America
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State/province [4]
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Louisiana
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Country [5]
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United States of America
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State/province [5]
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Minnesota
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Country [6]
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United States of America
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State/province [6]
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Missouri
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Country [7]
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United States of America
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State/province [7]
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New York
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Country [8]
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United States of America
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State/province [8]
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Ohio
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Country [9]
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United States of America
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State/province [9]
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Pennsylvania
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Country [10]
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United States of America
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State/province [10]
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Texas
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Respirion Pharmaceuticals Pty Ltd
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
A double-blind, active-controlled, multiple-ascending dose, safety study of aerosolized RSP-1502 in subjects with cystic fibrosis Pseudomonas aeruginosa lung infection.
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Trial website
https://clinicaltrials.gov/study/NCT06016088
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Brian Jones, PhD
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Address
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Country
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Phone
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215-732-5452
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Fax
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Email
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bjones@respirionpharma.com
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06016088
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