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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT06016088
Registration number
NCT06016088
Ethics application status
Date submitted
21/08/2023
Date registered
29/08/2023
Date last updated
24/05/2024
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 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 and Day 2
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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
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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
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Eligibility
Key inclusion 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.
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Minimum age
18
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 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.
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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/Phase 2
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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
1/04/2025
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Actual
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Sample size
Target
52
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,SA,WA
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Recruitment hospital [1]
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The Alfred 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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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [4]
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Lung Institute of Western Australia - Nedlands
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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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- Adelaide
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Recruitment postcode(s) [4]
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- Nedlands
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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/ct2/show/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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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT06016088
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