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Inhaled NO in IPF and COPD During 6 Minute Walk Test

Primary Purpose

COPD, IPF, Inhaled Nitric Oxide

Status

Unknown status

Phase

Phase 2

Locations

Israel

Study Type

Interventional

Intervention

Inhaled nitric oxide

About this trial

This is an interventional treatment trial for COPD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Rabin Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

COPD

IPF

Arm Description

Each participant will undergo two six minute walk tests and the results will be compared within each subject.

Outcomes

Primary Outcome Measures

Saturation level during the test

AUC of the saturation value during six minute walk test

Secondary Outcome Measures

Full Information

NCT ID

NCT03873298

First Posted

March 11, 2019

Last Updated

December 24, 2019

Sponsor

Rabin Medical Center

Collaborators

Bellerophon

1. Study Identification

Unique Protocol Identification Number

NCT03873298

Brief Title

Inhaled NO in IPF and COPD During 6 Minute Walk Test

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Unknown status

Study Start Date

March 4, 2019 (Actual)

Primary Completion Date

March 4, 2020 (Anticipated)

Study Completion Date

September 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rabin Medical Center

Collaborators

Bellerophon

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COPD, IPF, Inhaled Nitric Oxide, Six Minute Walk Test, Oxygen Saturation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

RCT, placebo controlled

Masking

Participant

Masking Description

The participants don't know if the cartridge used in the INO device is placebo or NO

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

COPD

Arm Type

Experimental

Arm Description

Each participant will undergo two six minute walk tests and the results will be compared within each subject.

Arm Title

IPF

Arm Type

Experimental

Arm Description

Each participant will undergo two six minute walk tests and the results will be compared within each subject.

Intervention Type

Drug

Intervention Name(s)

Inhaled nitric oxide

Intervention Description

Inhaled nitric oxide delivered through a pulsatile nitric oxide drug delivery system

Primary Outcome Measure Information:

Title

Saturation level during the test

Description

AUC of the saturation value during six minute walk test

Time Frame

26 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with COPD with disease severity of GOLD stage 3-4 Patients with IPF with a Forced vital capacity under 80% and a diffusion capacity under 60% Ambulatory patients that can perform a 6-minute walk test Exclusion Criteria: Patients with moderate to severe heart failure - EF < 40% Patients with severe PVD or scleroderma

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Barak Pertzov, MD

Phone

972548080196

pertzovb@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mordechai Kramer, MD

Organizational Affiliation

Rabin Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rabin Medical Center

City

Petach Tikva

ZIP/Postal Code

49100

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mordechai R Kramer, MD

First Name & Middle Initial & Last Name & Degree

Mordechai R Kramer, MD

12. IPD Sharing Statement

Plan to Share IPD

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Inhaled NO in IPF and COPD During 6 Minute Walk Test

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