Inhaled NO in IPF and COPD During 6 Minute Walk Test

The Influence of Inhaled Nitric Oxide on Oxygen Saturation of Patients With COPD and IPF During Six Minute Walk Test.

Our objective is to evaluate the influence of inhaled NO on the saturation and exercise capacity of patients with COPD and IPF. each participant will undergo two six minute walk tests, one with inhaled NO and the other with placebo.

Study Overview

• Status: Unknown
• Conditions: COPD; Oxygen Saturation; IPF; Inhaled Nitric Oxide; Six Minute Walk Test
• Intervention / Treatment: Drug: Inhaled nitric oxide

Detailed Description

This is a randomiized, placebo controlled trail that will evaluate the influence of inhaled NO (INO) on the saturation and exercise capacity of patients with COPD and IPF. All patients will sign a consent form before enrolment. Each patient will undergo two six-minute walk tests. Whether the INO will be used in the first or the second trial will be determined by computer generated randomization with random numbers sealed in opaque envelops. For the placebo 6-minute test we will use placebo cartridges in the INO generator, for INO 6-minute test we will use NO cartridges. The treatment with INO or placebo will start 20 minutes before the 6-minute walk test and will end at the end of the 6-minute walk test. Between tests a time interval of at least 60 minutes will be kept. During the test, the patients' pulse and saturation level will be monitored with a pulse oximetry. The data will be recorded continuously from baseline to 5 minutes after the test is over. The distance the patient walked will also be recorded. Patients that require supplemental oxygen will perform the tests with oxygen supplementation.

Dosing The NO dosing will be fixed. The first 10 patients will be treated with INO at a dose of 45 parts per million (ppm) per kilogram (kg). from patient 10 to 20 a dose of 75 ppm per kg will be given and from patient 20-100 a dose of 115 ppm per kg will be given.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Barak Pertzov, MD; Phone Number: 972548080196; Email: pertzovb@gmail.com

Study Locations

• Israel
  • Petach Tikva, Israel, 49100
    • Recruiting
    • Rabin Medical Center
    • Principal Investigator: Mordechai R Kramer, MD
    • Contact: Mordechai R Kramer, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients with COPD with disease severity of GOLD stage 3-4
2. Patients with IPF with a Forced vital capacity under 80% and a diffusion capacity under 60%
3. Ambulatory patients that can perform a 6-minute walk test

Exclusion Criteria:

1. Patients with moderate to severe heart failure - EF < 40%
2. Patients with severe PVD or scleroderma

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: COPD; Each participant will undergo two six minute walk tests and the results will be compared within each subject.	Drug: Inhaled nitric oxide; Inhaled nitric oxide delivered through a pulsatile nitric oxide drug delivery system
Experimental: IPF; Each participant will undergo two six minute walk tests and the results will be compared within each subject.	Drug: Inhaled nitric oxide; Inhaled nitric oxide delivered through a pulsatile nitric oxide drug delivery system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Saturation level during the test	AUC of the saturation value during six minute walk test	26 minutes

Collaborators and Investigators

• Sponsor: Rabin Medical Center
• Collaborators: Bellerophon
• Investigators: Principal Investigator: Mordechai Kramer, MD, Rabin Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2019
• Primary Completion (Anticipated): March 4, 2020
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: March 11, 2019
• First Submitted That Met QC Criteria: March 11, 2019
• First Posted (Actual): March 13, 2019

Study Record Updates

• Last Update Posted (Actual): December 26, 2019
• Last Update Submitted That Met QC Criteria: December 24, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Antioxidants; Free Radical Scavengers; Endothelium-Dependent Relaxing Factors; Gasotransmitters; Nitric Oxide
• Other Study ID Numbers: 0135-18-rmc

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes