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

Pulmonary Disease, Chronic Obstructive Clinical Trial

— rehabilitate  

Official title:

Single Centre, Exploratory, Phase II, Cross-over, Randomised Trial, Evaluating the Effect of Spontaneously Breathing He/O2 65%/35% to Either Spontaneously Breathing N2/O2 65%35% or Non-Invasive Ventilated N2/O2 65%/35% on a 6 Minute Walk Test in Severe COPD Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01355809
• Other study ID #: ALMED-07-C2-017
• Status: Terminated
• Phase: Phase 2
• First received: May 17, 2011
• Last updated: August 8, 2014
• Start date: December 2009
• Est. completion date: May 2011

Study information

• Verified date: August 2014
• Source: Air Liquide SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: The Bavarian State Ministry of the Environment and Public Health
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: May 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Inhalation gas
Inhalated gas, medicinal oxygen 100% via NIV with Fi O2 0.35, one time by random, 6 minutes
• Inhalation Nitrogen/Oxygen
Inhalated gas, Nitrogen/Oxygen (65%/35%), one time by random, 6 minutes
• Inhalation Helium/Oxygen
Inhalated gas, Helium/Oxygen (65%/35%) one time by random, 6 minutes

Locations

Country	Name	City	State
Germany	Asklepios Fachkliniken München-Gauting	Gauting

Sponsors (2)

Lead Sponsor	Collaborator
Air Liquide SA	Asklepios Kliniken Hamburg GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distance walked	evaluate the distance walked by patients during a Six-Minute Walk Test	6 minutes	No
Secondary	Assessment of the safety of inhalation Helium/Oxygen	evaluate the safety of the administration of Helium/Oxygen 65%/35%	6 minutes	Yes