Six-Minute Walk Test Comparing Helium/Oxygen to Nitrogen/Oxygen for COPD Rehabilitation (rehabilitate)

Air Liquide

Status and phase: Terminated; Phase 2

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: Inhalation Helium/Oxygen; Drug: Inhalation gas; Drug: Inhalation Nitrogen/Oxygen

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01355809

ALMED-07-C2-017

Details and patient eligibility

About

The purpose of this study is to evaluate effects of inspired gas mixtures on the distance walked by patients with severe Chronic Obstructive Pulmonary Disease (COPD) during a Six-Minute Walk test.

Full description

the purpose of this study is to evaluate the distance walked by patients with severe Chronic Obstructive Pulmonary Disease (COPD) during a Six-Minute Walk test (6MWT) while breathing Helium/Oxygen 65%/35% compared to either breathing Nitrogen/Oxygen 65%/35% or receiving Non-Invasive Ventilation (NIV) with a FiO2 of 0.35 and to evaluate exercise related symptoms

Enrollment: 3 patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female aged >= 45 and <= 75 years old
• Patient with documented clinical diagnosis of stage III/IV COPD
• Patient with stable COPD defined by no significant increase in COPD medication, no treatment for COPD in an emergency, no acute intensive care setting and no intake of antibiotics in the four weeks prior to selection

Exclusion criteria

• Inability or contra-indication to perform pulmonary function tests
• Inability or contra-indication to perform the 6MWT with a trolley
• Any contra-indication to receive NIV
• Obese patient having a Body Mass Index (BMI) > 35
• Pregnant or lactating woman
• Female or chil-bearing potential with lack of efficient contraception

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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3 participants in 3 patient groups

Inhalation Nitrogen/Oxygen

Active Comparator group

Description:

Nitrogen/Oxygen (65%/35%)

Treatment:

Drug: Inhalation Nitrogen/Oxygen

Inhalation Helium/Oxygen

Experimental group

Description:

Helium/Oxygen (65%/35%)

Treatment:

Drug: Inhalation Helium/Oxygen

Inhalation gas

Experimental group

Description:

Medicinal oxygen 100% via NIV with FiO2 of 0.35

Treatment:

Drug: Inhalation gas