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Hypertension, PulmonaryEFSNCT05867914

Early Feasibility Study Evaluating the 3P-100 Device in Subjects With PH-ILD

A study testing Inhaled Nitric Oxide (iNO) in people with Hypertension, Pulmonary and Lung Diseases, Interstitial, run by Third Pole Therapeutics, Inc. at 3 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

A trial to evaluate the safety, tolerability, and functionality of 3P-100, in subjects with Pulmonary Hypertension (PH) accompanying Interstitial Lung Disease (ILD), PH-ILD Read more about this study

Who is it for?
Ages 22 to 84 years
What is being tested?
Inhaled Nitric Oxide (iNO)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
3 sitesUnited States
Study dates
4 Dec 2023to 29 Mar 2024
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 to 84 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female age 22 to < 85 years old
  • Provides signed informed consent for study participation
  • Diagnosis of any form of advanced Interstitial Lung Disease or Combined Pulmonary Fibrosis and Emphysema (CPFE) at any time, based on clinical, pulmonary function, serological, and Computed Tomography (CT) radiologic evidence (which demonstrates evidence of moderate to severe diffuse parenchymal lung disease)
  • A prior Right Heart Catheterization (RHC) at any time before SV that demonstrates PH with a Pulmonary Vascular Resistance (PVR) >2.0 Wood Units (WU), a mean Pulmonary Arterial Pressure (mPAP) > 20 mmHg, and a Pulmonary Capillary Wedge Pressure (PCWP) ≤ 15 mmHg. A PCWP >15 mmHg is not exclusionary if a left ventricular end diastolic pressure (LVEDP) is available and is ≤ 15 mmHg by left heart catheterization AND/OR Previous Echocardiography with an intermediate/high probability of PH (European Society of Cardiology definition)
  • New York Heart Association (NYHA) functional class II-IV
  • Self-reported use of long-term O2 therapy (LTOT) less than or equal to 10 L/minute at rest and while exercising, defined as use for at least 12 hours per day for at least 30 days prior to SV
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  • Is willing to comply with treatment with iNO and procedures including using the 3P-100 device and wearing a nasal cannula for at least 4 hours at V1
  • Is able to wear a 3P-100 device while sitting and ambulating intermittently in the clinic area for at least 30 minutes during SV
  • Women of child-bearing potential must agree to use the methods of birth control indicated in Appendix 1 from consent through the Telephone Call at V1 +1 Day

Who cannot join

  • History or diagnosis by Investigator evaluation during SV of World Health Organization (WHO) Group I, II, IV, or V PH
  • NYHA class IV patients who are medically unfit to participate i.e., are constantly breathless at rest or have frequent symptoms of chest pain or syncope at rest or with activity
  • History or diagnosis of acute or chronic left heart failure at any time as evidenced by one or more of the following:
  • PCWP > 15 mmHg on a previous RHC (unless LVEDP is ≤15 mmHg) AND/OR LVEDP >15 mmHg by left heart catheterization
  • Previous echocardiographic findings of left ventricular systolic dysfunction with ejection fraction < 40%
  • Cardiogenic pulmonary edema
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  • History of left heart failure (Prior or current use of medications given solely for the treatment of systemic hypertension are allowed)
  • History of hereditary methemoglobinemia
  • History of the following cardiovascular conditions:
  • Stenting or Coronary Artery Bypass Graft (CABG) within 60 days prior to SV
  • Myocardial infarction within the 60 days prior to SV
  • Unstable angina pectoris in the 60 days prior to SV
  • Intermittent atrial fibrillation, supraventricular tachycardia, and serious ventricular arrhythmias (e.g., ventricular tachycardia) within 60 days prior to SV. Ablated atrial flutter or Wolf-Parkinson-White (WPW) bypass tract conduction are not exclusionary
  • Cerebrovascular accident within the 60 days prior to SV
  • Has within 30 days prior to SV or during the Screening period
  • Participated in any clinical study involving an investigational drug, investigational biologic, or investigational device
  • Required unplanned hospitalization for any reason
  • Had an exacerbation of ILD requiring administration of oral or parenteral antibiotic
  • Has within the 30 days prior to SV or during the Screening period required initiation or changes in the regimen (including agents, dose, and frequency) of medications prescribed for the treatment of ILD, including but not limited to immunosuppressive / immunomodulatory medications, systemic oral or parenteral corticosteroids, and monoclonal antibodies
  • Has within 30 days prior to SV, or any time during Screening period taken one or more of the following medications or supplements chronically:
  • Oral, inhaled, or parenteral medications for the treatment of Pulmonary Arterial Hypertension (PAH) irrespective of the route of administration including, but not limited to,
  • high dose calcium channel blockers
  • riociguat
  • prostacyclins
  • prostacyclin analogues
  • prostacyclin receptor agonists (e.g., selexipag)
  • phosphodiesterase type 5 (PDE5) inhibitors (e.g., sildenafil) if the subject is on inhaled treprostinil
  • endothelin receptor antagonists
  • Inhaled treprostinil (approved for PH-ILD), if the subject is on a PDE5 inhibitor for PH-ILD
  • Note: Inhaled treprostinil is not exclusionary as a monotherapy, however, the concurrent use of both a PDE5 inhibitor (e.g., sildenafil) and inhaled treprostinil is exclusionary. The use of either a PDE5 inhibitor or inhaled treprostinil will be allowed if both conditions are met:
  • The PDE5 inhibitor or inhaled treprostinil was started more than 30 days prior to the SV.
  • There have been no changes in the PDE5 inhibitor or inhaled treprostinil dosage within 30 days prior to the SV.
  • Nitrates, regardless of route of administration
  • Supplements containing L-arginine
  • Agents or medications capable of inducing methemoglobinemia where any of the SV/V1 metHb average measurements via co-oximeter are > 3.5%
  • Subjects should not be weaned from these therapies for the purpose of enrollment.
  • Is breastfeeding or lactating at the time of SV or intends to breastfeed at any time during their participation in the study
  • Has one of the following in their medical record or through testing performed:
  • Positive urine pregnancy test at SV or on V1 (results of the test are to be known prior to initiation of the iNO)
  • Hemoglobin < 10 g/dL (100 g/L) within 30 days of SV
  • HbA1c > 10% within 30 days of SV
  • Glomerular Filtration Rate (GFR) < 30 mL/min/1.73 m2 , calculated using the Creatinine Clearance (CKD-EPI) calculation method within 30 days of SV
  • Methemoglobin > 3.5% at SV or V1 via co-oximeter measurements
  • Thrombocytopenia with a platelet count < 50 x 103 /µL (< 50 X 109/L) within 30 days of SV
  • Has any condition at SV/V1 that could constitute a safety concern during participation in the study or could interfere with the subject's ability to comply with adherence to iNO, including but not limited to:
  • Uncontrolled systemic hypertension defined by systolic Blood Pressure (BP) > 180 mmHg and/or a diastolic BP > 110 mmHg measured manually after 20 minutes at rest on prescribed resting O2
  • History of alcohol or substance abuse within the past 365 days prior to SV. Drugs documented as prescribed by a physician or use of edible marijuana if legal in the state of residence may be allowed with approval of the Medical Monitor. Smoking and vaping of any substance is prohibited (e.g., nicotine or marijuana)
  • History of poor compliance with prior clinical studies
  • Acute or chronic physical impairment (other than dyspnea due to ILD) (e.g., neurologic, musculoskeletal, or orthopedic disorder, or dependence on mobility aids such as a cane or walker) that would limit the ability to carry and operate the 3P-100 device together with their O2 system
  • Severe right heart failure confirmed by the investigator as evidenced by two or more of the following: elevated jugular venous pressure, peripheral edema, hepatic congestion and/or ascites
  • Other known coagulopathies
  • Is a relative of Third Pole, the Contract Research Organization (CRO) or other vendor, or investigational site/institutional personnel
  • Has during the SV one or more of the following results:
  • Forced Expiratory Volume (FEV1)/Forced Vital Capacity (FVC) ratio < 0.7 except for CPFE
  • FVC < 40% predicted

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • University of Cincinnati

    Cincinnati, Ohio, 45627

  • TGH/USF Center for Advanced Lung Disease and Lung Transplant

    Tampa, Florida, 33606

Other trials in United States

About this study

Official title: A Within-subject Device-setting Escalation Early Feasibility Study Evaluating the Safety, Tolerability, and Functionality of 3P-100 in Subjects With PH-ILD

A trial to evaluate the safety, tolerability, and functionality of 3P-100, in subjects with Pulmonary Hypertension (PH) accompanying Interstitial Lung Disease (ILD), PH-ILD

Read the detailed description

This is a multi-center early feasibility study evaluating the safety and tolerability of the 3P-100 device which creates and delivers iNO (2 mg/hr and 6 mg/hr) for the treatment of subjects with PH-ILD. All subjects will use the 3P-100 device and receive iNO (2 mg/hr and 6 mg/hr) via the 3P-100 device, aiming for ~4-4.5 hours of treatment across both device settings.

Being tested
Inhaled Nitric Oxide (iNO)
Keywords
inhaled NO, PH-ILD
Medical subject headings
Hypertension, Pulmonary, Lung Diseases, Interstitial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Inhaled Nitric Oxide (iNO)Device

    eNOfit system delivering iNO

Study groups in NCT05867914
Study groupRoleWhat they receive
Inhaled Nitric Oxide (iNO)ExperimentaleNOfit an Electric Nitric Oxide (NO) Ambulatory Production and Delivery System, Delivering Nitric Oxide for Inhalation The treatment period with inhaled Nitric Oxide (iNO) will include start of iNO at a device setting of 2 mg/hr iNO for 2 hours (+15 minutes), device setting escalation to 6 mg/hr iNO for 2 hours (+15 minutes) and then weaning of iNO treatment
Receives: Device: Inhaled Nitric Oxide (iNO)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Adverse Events [By evaluating safety and tolerability of ascending device settings of iNO administered in the clinic with the 3P-100 device in PH-ILD]

    Incidence of Adverse Events as assessed by CTCAE v5.0

    Measured: Day 1

Secondary outcomes (2)

  1. Effect of iNO on oxygen saturation

    Assessment of the effect of iNO on oxygen saturation as assessed by SpO2 (Pulse Oximetry)

    Measured: Day 0

  2. Device Usability Questionnaire (Created by Third Pole)

    Assessment of the responses on the Device Usability Questionnaire completed by the Subject.

    It is a 5 point scale.

    1 = Very Difficult, Completely Unacceptable 5 = Very Easy, Completely Acceptable

    Measured: Day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2023
  2. Study start4 Dec 2023
  3. Primary completion10 Feb 2024
  4. Study completion29 Mar 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
eNOfit system delivering iNO
Masking
None (open label)
Enrolment
5 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05867914
Sponsor's protocol ID
3P-100-ILD-00
Acronym
EFS
Status last verified
Feb 2024
First submitted
1 May 2023
Last updated
14 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Inhaled Nitric Oxide (iNO) in people with Hypertension, Pulmonary and Lung Diseases, Interstitial, run by Third Pole Therapeutics, Inc. at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 55 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse Events [By evaluating safety and tolerability of ascending device settings of iNO administered in the clinic with the 3P-100 device in PH-ILD] (time frame: Day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05867914.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2024.

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