Inhaled NO in IPF and COPD During 6 Minute Walk Test

COPD Clinical Trial

Official title:

The Influence of Inhaled Nitric Oxide on Oxygen Saturation of Patients With COPD and IPF During Six Minute Walk Test.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03873298
• Other study ID #: 0135-18-rmc
• Status: Recruiting
• Phase: Phase 2
• Start date: March 4, 2019
• Est. completion date: September 1, 2020

Study information

• Verified date: December 2019
• Source: Rabin Medical Center
• Contact: Barak Pertzov, MD
• Phone: 972548080196
• Email: pertzovb[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 1, 2020
• Est. primary completion date: March 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD
• Inhaled Nitric Oxide
• IPF
• Oxygen Saturation
• Respiratory Aspiration
• Six Minute Walk Test

Intervention

Drug:
• Inhaled nitric oxide
Inhaled nitric oxide delivered through a pulsatile nitric oxide drug delivery system

Locations

Country	Name	City	State
Israel	Rabin Medical Center	Petach Tikva

Sponsors (2)

Lead Sponsor	Collaborator
Rabin Medical Center	Bellerophon

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Saturation level during the test	AUC of the saturation value during six minute walk test	26 minutes