MedDataX Logo

Inhaled NO in IPF and COPD During 6 Minute Walk Test

NCT ID: NCT03873298

Last Updated: 2019-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-04

Study Completion Date

2020-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COPD IPF Inhaled Nitric Oxide Six Minute Walk Test Oxygen Saturation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

RCT, placebo controlled
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

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

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

COPD

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

Group Type EXPERIMENTAL

Inhaled nitric oxide

Intervention Type DRUG

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

IPF

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

Group Type EXPERIMENTAL

Inhaled nitric oxide

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Inhaled nitric oxide

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bellerophon

INDUSTRY

Sponsor Role collaborator

Rabin Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mordechai Kremer

Head of the pulmonary division

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mordechai Kramer, MD

Role: PRINCIPAL_INVESTIGATOR

Rabin Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Rabin Medical Center

Petah Tikva, , Israel

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Israel

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Barak Pertzov, MD

Role: CONTACT

Phone: 972548080196

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Mordechai R Kramer, MD

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 38724947 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0135-18-rmc

Identifier Type: -

Identifier Source: org_study_id