Inhaled NO in IPF and COPD During 6 Minute Walk Test | NCT03873298

Studies
Inhaled NO in IPF and COPD During 6 Minute Walk Test

NCT03873298

Sponsor

Rabin Medical Center

Status

Unknown status

Last Update Posted

Dec 26, 2019Actual

Enrollment

100Estimated

Phase

Phase 2

Conditions

COPD
IPF
Inhaled Nitric Oxide
Six Minute Walk Test
Oxygen Saturation

Interventions

Inhaled nitric oxide

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 4, 2019Actual

Primary Completion Date

Mar 4, 2020Estimated

Completion Date

Sep 1, 2020Estimated

First Submitted Date

Mar 11, 2019

First Submission Date that Met QC Criteria

Mar 11, 2019

First Posted Date

Mar 13, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 24, 2019

Last Update Posted Date

Dec 26, 2019Actual

Name	Class
Bellerophon	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
COPD	Experimental	Each participant will undergo two six minute walk tests and the results will be compared within each subject.	Drug: Inhaled nitric oxide
IPF	Experimental	Each participant will undergo two six minute walk tests and the results will be compared within each subject.	Drug: Inhaled nitric oxide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Inhaled nitric oxide	Drug	Inhaled nitric oxide delivered through a pulsatile nitric oxide drug delivery system	COPD IPF

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Barak Pertzov, MD	Contact	972548080196		pertzovb@gmail.com

Overall Officials

Name	Affiliation	Role
Mordechai Kramer, MD	Rabin Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rabin Medical Center	Recruiting	Petah Tikva		49100	Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38724947	Derived	Freidkin L, Kramer MR, Rosengarten D, Izhakian S, Taieb S, Pertzov B. The acute effect of inhaled nitric oxide on the exercise capacity of patients with advanced interstitial lung disease: a randomized controlled trial. BMC Pulm Med. 2024 May 10;24(1):226. doi: 10.1186/s12890-024-03051-4.

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease