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

NCT05867914 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 3P-100-ILD-00
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 3

Brief 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

Conditions

Hypertension, Pulmonary; Lung Diseases, Interstitial

Keywords

inhaled NO, PH-ILD

Outcome Measures

Primary Outcomes (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

  Day 1

Secondary Outcomes (2)

• Effect of iNO on oxygen saturation

  Day 0

• Device Usability Questionnaire (Created by Third Pole)

  Day 0

Study Arms (1)

Inhaled Nitric Oxide (iNO)

EXPERIMENTAL

eNOfit 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

Device: Inhaled Nitric Oxide (iNO)

Interventions

Inhaled Nitric Oxide (iNO) DEVICE

eNOfit system delivering iNO

Inhaled Nitric Oxide (iNO)

Eligibility Criteria

• Age: 22 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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
• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Third Pole Therapeutics, Inc.: lead

Study Sites (3)

TGH/USF Center for Advanced Lung Disease and Lung Transplant

Tampa, Florida, 33606, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45627, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Hypertension, Pulmonary; Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Philip Silkoff, MD

  Chief Medical Officer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: eNOfit 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: eNOfit system delivering iNO

Study Record Dates

• First Submitted: May 1, 2023
• First Posted: May 22, 2023
• Study Start: December 4, 2023
• Primary Completion: February 10, 2024
• Study Completion: March 29, 2024
• Last Updated: February 14, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)