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临床试验/NCT03873298
NCT03873298Unknown2 期

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

Rabin Medical Center1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年3月4日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
100
试验地点
1
主要终点
Saturation level during the test

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Patients with moderate to severe heart failure - EF < 40%
  • Patients with severe PVD or scleroderma

研究组 & 干预措施

COPD

Experimental

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

干预措施: Inhaled nitric oxide (Drug)

IPF

Experimental

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

干预措施: Inhaled nitric oxide (Drug)

结局指标

主要结局

Saturation level during the test

时间窗: 26 minutes

AUC of the saturation value during six minute walk test

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mordechai Kremer

Head of the pulmonary division

Rabin Medical Center

研究点 (1)

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