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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/NCT05176951
Registration number
NCT05176951
Ethics application status
Date submitted
10/12/2021
Date registered
4/01/2022
Date last updated
25/03/2024
Titles & IDs
Public title
A Study to Evaluate the Safety and Tolerability of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease
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Scientific title
A Phase 2, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Safety and Tolerability of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease
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Secondary ID [1]
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2021-003294-66
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Secondary ID [2]
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INS1009-211
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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:
Pulmonary Hypertension
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Cardiovascular
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Hypertension
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Treprostinil Palmitil
Treatment: Drugs - Placebo
Experimental: Treprostinil Palmitil - Participants will be administered TPIP once per day at a starting dose of 80 micrograms (µg). Participants will be titrated up to the highest tolerated dose for each individual participant of between 80 µg and 640 µg during the initial 3 weeks of treatment. The overall treatment period will be 16 weeks.
Placebo Comparator: Placebo - Participants will be administered a placebo matching TPIP once daily.
Treatment: Drugs: Treprostinil Palmitil
Oral inhalation using a capsule-based dry powder inhaler device.
Treatment: Drugs: Placebo
Oral inhalation using a capsule-based dry powder inhaler device.
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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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Number of Participants Who Experience Any Number of Treatment Emergent Adverse Events (TEAEs)
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Assessment method [1]
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Timepoint [1]
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Up to Day 140
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Primary outcome [2]
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Number of Participants Who Experience Any Number of Serious Adverse Events (SAEs)
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Assessment method [2]
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Timepoint [2]
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Up to Day 140
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Primary outcome [3]
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Change from Baseline in Saturation of Peripheral Capillary Oxygenation (SpO2) Levels
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Assessment method [3]
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Timepoint [3]
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Pre-, during, and post- 6-minute walk test (6MWT) at Baseline, Week 5, Week 10, and Week 16
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Secondary outcome [1]
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Maximum Plasma Concentration (Cmax) of Treprostinil Palmitil
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Assessment method [1]
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Timepoint [1]
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Day 1 to Week 16
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Secondary outcome [2]
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Cmax of Treprostinil
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Assessment method [2]
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Timepoint [2]
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Day 1 to Week 16
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Secondary outcome [3]
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Time to Maximum Plasma Concentration (Tmax) of Treprostinil Palmitil
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Assessment method [3]
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Timepoint [3]
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Day 1 to Week 16
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Secondary outcome [4]
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Tmax of Treprostinil
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Assessment method [4]
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Timepoint [4]
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Day 1 to Week 16
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Secondary outcome [5]
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Area Under Concentration-time Curve From Time 0 to 24 Hours Post-dose (AUCtau) of Treprostinil Palmitil
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Assessment method [5]
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Timepoint [5]
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Day 1 to Week 16
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Secondary outcome [6]
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AUCtau of Treprostinil
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Assessment method [6]
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Timepoint [6]
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Day 1 to Week 16
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Secondary outcome [7]
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Area Under Concentration-time Curve From 0 to Infinity (AUC8) of Treprostinil Palmitil
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Assessment method [7]
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Timepoint [7]
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Day 1 to Week 16
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Secondary outcome [8]
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AUC8 of Treprostinil
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Assessment method [8]
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Timepoint [8]
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Day 1 to Week 16
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Secondary outcome [9]
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Area Under Concentration-time Curve From Time 0 to Last Measurable Concentration (AUClast) of Treprostinil Palmitil
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Assessment method [9]
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Timepoint [9]
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Day 1 to Week 16
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Secondary outcome [10]
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AUClast of Treprostinil
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Assessment method [10]
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Timepoint [10]
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Day 1 to Week 16
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Secondary outcome [11]
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Apparent Total Clearance (CL/F) of Treprostinil Palmitil
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Assessment method [11]
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Timepoint [11]
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Day 1 to Week 16
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Secondary outcome [12]
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CL/F of Treprostinil
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Assessment method [12]
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Timepoint [12]
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Day 1 to Week 16
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Secondary outcome [13]
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Elimination Half-life (t1/2) of Treprostinil Palmitil
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Assessment method [13]
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Timepoint [13]
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Day 1 to Week 16
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Secondary outcome [14]
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t1/2 of Treprostinil
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Assessment method [14]
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Timepoint [14]
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Day 1 to Week 16
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Secondary outcome [15]
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Apparent Volume of Distribution After Terminal Phase (Vd/F) of Treprostinil Palmitil
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Assessment method [15]
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Timepoint [15]
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Day 1 to Week 16
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Secondary outcome [16]
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Vd/F of Treprostinil
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Assessment method [16]
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Timepoint [16]
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Day 1 to Week 16
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Eligibility
Key inclusion criteria
- Males and females must be = 18 to = 80 years of age at the time of signing the
informed consent form (ICF).
- Diagnosis of pulmonary hypertension (PH) associated with interstitial lung disease
(ILD) (including idiopathic interstitial pneumonia [IIP], idiopathic pulmonary
fibrosis [IPF], connective tissue disease [CTD], sarcoidosis).
- Male and female participants must use contraceptives that are consistent with local
regulations regarding the methods of contraception for those participating in clinical
studies.
- Male participants:
Male participants who are not sterile, with female partners of childbearing potential, must
be using effective contraception from Day 1 to at least 90 days after the last dose of
study drug.
Male participants with women of child bearing potential (WOCBP) partner must use a condom
in order to avoid potential exposure to embryo/fetus.
- Female participants: Women must be postmenopausal (defined as no menses for 12 months
without an alternative medical cause), surgically sterile, (ie,hysterectomy and/or
bilateral salpingo-oophorectomy) or using highly effective contraception methods (ie,
methods that alone or in combination achieve <1% unintended pregnancy rates per year when
used consistently and correctly) from Day 1 to at least 90 days after the last dose of
study drug.
- Capable of giving signed informed consent that includes compliance with the requirements
and restrictions listed in the ICF and in this protocol.
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Minimum age
18
Years
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Maximum age
80
Years
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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
- Primary diagnosis of chronic obstructive pulmonary disease (COPD).
- Allergy, or documented hypersensitivity or contraindication to TPIP or treprostinil
(TRE) or mannitol (an excipient of the TPIP formulation).
- Received or currently treated with riociguat, endothelin receptor antagonists,
selexipag, phosphodiesterase 5 (PDE5) inhibitors and/or prostacyclin analogues within
30 days prior to Screening.
- Started therapy with pirfenidone or nintedanib < 90 days prior to Screening, OR, if
already receiving either medication, there is a dose change within 30 days of
Screening Visit.
- Any known ventricular or supraventricular tachyarrhythmia (except for paroxysmal
atrial fibrillation), and/or any symptomatic bradycardia.
- History of heart disease including left ventricular ejection fraction (LVEF) = 40% or
clinically significant valvular, constrictive, or symptomatic atherosclerotic heart
disease (eg, stable angina, myocardial infarction, etc).
- Participation in a cardiopulmonary rehabilitation program within 30 days of the first
Screening Visit. Participation in the maintenance program of a cardiopulmonary
rehabilitation program is allowed.
- Acutely decompensated heart failure within 30 days of Screening Visit.
- Active and current symptomatic coronavirus disease 2019 (COVID-19) and/or previous
diagnosis of moderate to severe disease, or hospitalization due to COVID-19.
- Supplemental oxygen requirement > 10L/min at rest at Screening.
- Exacerbation of underlying lung disease or active pulmonary or upper respiratory
infection within 30 days of the first dose of study drug (may be rescreened at
appropriate time).
- Current or recent (past 30 days) lower respiratory tract infection (may be rescreened
at appropriate time).
- Any form of congenital heart disease or congenital heart defect (repaired or
unrepaired) other than a patent foramen ovale.
- History of alcohol or drug abuse within 6 months prior to Screening.
- Current use of cigarettes (as defined by Center for Disease Control (CDC)) or
e-cigarettes: An adult who has smoked at least 100 cigarettes in his or her lifetime
and who currently smokes either every day or some days.
- Participants who currently inhale marijuana (recreational or medical).
- Acute or chronic impairment (other than dyspnea), limiting the ability to comply with
study requirements, in particular with 6-minute walk test (6MWT) (eg, angina pectoris,
claudication, musculoskeletal disorder, need for walking aids).
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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 analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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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
22/12/2022
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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
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Actual
14/03/2024
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Sample size
Target
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Accrual to date
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Final
39
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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AUS003 - Camperdown
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Recruitment hospital [2]
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AUS005 - Macquarie Park
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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2109 - Macquarie Park
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Recruitment outside Australia
Country [1]
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Argentina
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State/province [1]
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Ciudad Autónoma De BuenosAires
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Country [2]
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Argentina
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State/province [2]
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Santa Fe
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Country [3]
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Argentina
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State/province [3]
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Buenos Aires
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Country [4]
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Belgium
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State/province [4]
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Liège
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Country [5]
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Germany
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State/province [5]
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Baden-Württemberg
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Country [6]
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Germany
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State/province [6]
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Hessen
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Country [7]
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Germany
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State/province [7]
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Nordrhein-Westfalen
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Country [8]
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Germany
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State/province [8]
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Sachsen
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Country [9]
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Germany
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State/province [9]
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Berlin
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Country [10]
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Germany
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State/province [10]
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Munich
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Country [11]
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Italy
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State/province [11]
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Campania
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Country [12]
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Italy
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State/province [12]
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Lombardia
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Country [13]
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Italy
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State/province [13]
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Sicilia
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Country [14]
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Spain
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State/province [14]
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Asturias
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Country [15]
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Spain
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State/province [15]
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Baleares
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Country [16]
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Spain
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State/province [16]
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Barcelona
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Country [17]
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Spain
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State/province [17]
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las Palmas de Gran Canaria
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Country [18]
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Spain
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State/province [18]
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Santiago de Compostela
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Country [19]
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United Kingdom
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State/province [19]
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Lanarkshire
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Country [20]
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United Kingdom
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State/province [20]
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Yorkshire
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Insmed Incorporated
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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
The primary objective of this study is to evaluate the safety and tolerability of
treprostinil palmitil inhalation powder (TPIP) compared with placebo
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05176951
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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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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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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 scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05176951
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