Inhaled NO in IPF and COPD During 6 Minute Walk Test

Sponsor

Rabin Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT03873298

Collaborator

Bellerophon (Industry)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

5.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
COPD IPF Inhaled Nitric Oxide Six Minute Walk Test Oxygen Saturation	Drug: Inhaled nitric oxide	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

RCT, placebo controlledRCT, placebo controlled

Masking:

Single (Participant)

Masking Description:

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

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 4, 2019

Anticipated Primary Completion Date :

Mar 4, 2020

Anticipated Study Completion Date :

Sep 1, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Saturation level during the test [26 minutes]
AUC of the saturation value during six minute walk test

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rabin Medical Center	Petach Tikva		Israel	49100

Sponsors and Collaborators

Rabin Medical Center
Bellerophon

Investigators

Principal Investigator: Mordechai Kramer, MD, Rabin Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mordechai Kremer, Head of the pulmonary division, Rabin Medical Center

ClinicalTrials.gov Identifier:

NCT03873298

Other Study ID Numbers:

0135-18-rmc

First Posted:

Mar 13, 2019

Last Update Posted:

Dec 26, 2019

Last Verified:

Dec 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

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

Additional relevant MeSH terms:

Respiratory Aspiration

Nitric Oxide

Study Results

No Results Posted as of Dec 26, 2019