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Inhaled NO in IPF and COPD During 6 Minute Walk Test

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ClinicalTrials.gov Identifier: NCT03873298
Recruitment Status : Recruiting
First Posted : March 13, 2019
Last Update Posted : March 13, 2019
Sponsor:
Collaborator:
Bellerophon
Information provided by (Responsible Party):
Mordechai Kremer, Rabin Medical Center

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: RCT, 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 : March 4, 2019
Estimated Primary Completion Date : March 4, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Saturation level during the test [ Time Frame: 26 minutes ]
    AUC of the saturation value during six minute walk test



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03873298


Contacts
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Contact: Barak Pertzov, MD 972548080196 pertzovb@gmail.com

Locations
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Israel
Rabin Medical Center Recruiting
Petach Tikva, Israel, 49100
Contact: Mordechai R Kramer, MD         
Principal Investigator: Mordechai R Kramer, MD         
Sponsors and Collaborators
Rabin Medical Center
Bellerophon
Investigators
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Principal Investigator: Mordechai Kramer, MD Rabin Medical Center

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Responsible Party: Mordechai Kremer, MD, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT03873298     History of Changes
Other Study ID Numbers: 0135-18-rmc
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents