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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

Tracking Information
First Submitted Date  ICMJE March 11, 2019
First Posted Date  ICMJE March 13, 2019
Last Update Posted Date March 13, 2019
Actual Study Start Date  ICMJE March 4, 2019
Estimated Primary Completion Date March 4, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 11, 2019)
Saturation level during the test [ Time Frame: 26 minutes ]
AUC of the saturation value during six minute walk test
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Inhaled NO in IPF and COPD During 6 Minute Walk Test
Official Title  ICMJE The Influence of Inhaled Nitric Oxide on Oxygen Saturation of Patients With COPD and IPF During Six Minute Walk Test.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE
  • COPD
  • IPF
  • Inhaled Nitric Oxide
  • Six Minute Walk Test
  • Oxygen Saturation
Intervention  ICMJE Drug: Inhaled nitric oxide
Inhaled nitric oxide delivered through a pulsatile nitric oxide drug delivery system
Study Arms  ICMJE
  • Experimental: COPD
    Each participant will undergo two six minute walk tests and the results will be compared within each subject.
    Intervention: Drug: Inhaled nitric oxide
  • Experimental: IPF
    Each participant will undergo two six minute walk tests and the results will be compared within each subject.
    Intervention: Drug: Inhaled nitric oxide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 11, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2020
Estimated Primary Completion Date March 4, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Barak Pertzov, MD 972548080196 pertzovb@gmail.com
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03873298
Other Study ID Numbers  ICMJE 0135-18-rmc
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mordechai Kremer, Rabin Medical Center
Study Sponsor  ICMJE Rabin Medical Center
Collaborators  ICMJE Bellerophon
Investigators  ICMJE
Principal Investigator: Mordechai Kramer, MD Rabin Medical Center
PRS Account Rabin Medical Center
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP