Inhaled NO in IPF and COPD During 6 Minute Walk Test
The Influence of Inhaled Nitric Oxide on Oxygen Saturation of Patients With COPD and IPF During Six Minute Walk Test.
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2019
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 4, 2019
CompletedFirst Submitted
Initial submission to the registry
March 11, 2019
CompletedFirst Posted
Study publicly available on registry
March 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 4, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedDecember 26, 2019
December 1, 2019
1 year
March 11, 2019
December 24, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Saturation level during the test
AUC of the saturation value during six minute walk test
26 minutes
Study Arms (2)
COPD
EXPERIMENTALEach participant will undergo two six minute walk tests and the results will be compared within each subject.
IPF
EXPERIMENTALEach participant will undergo two six minute walk tests and the results will be compared within each subject.
Interventions
Inhaled nitric oxide delivered through a pulsatile nitric oxide drug delivery system
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients with moderate to severe heart failure - EF \< 40%
- Patients with severe PVD or scleroderma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rabin Medical Centerlead
- Bellerophoncollaborator
Study Sites (1)
Rabin Medical Center
Petah Tikva, 49100, Israel
Related Publications (1)
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.
PMID: 38724947DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mordechai Kramer, MD
Rabin Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- The participants don't know if the cartridge used in the INO device is placebo or NO
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of the pulmonary division
Study Record Dates
First Submitted
March 11, 2019
First Posted
March 13, 2019
Study Start
March 4, 2019
Primary Completion
March 4, 2020
Study Completion
September 1, 2020
Last Updated
December 26, 2019
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will not share