A single centre, exploratory, phase II, cross-over, randomised trial, evaluating the effect of spontaneously breathing Helium/Oxygen (65%/35%), to either spontaneously breating Nitrogen/Oxygen (65%/35%) on the Six-Minute Walking Distance in severe COPD patients - Lung Function Exercising

• Conditions: Severe chronic obstructive pneumonary disease (COPD) patients during a Six-Minute Walking Test; MedDRA version: 12.0Level: LLTClassification code 10009033Term: Chronic obstructive pulmonary disease

• Registration Number: EUCTR2007-007775-17-DE
• Lead Sponsor: Air Liquide

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-03
• Last Update Posted: 23 September 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

- Male or female aged 45 and 80 years old,
- Patient with documented clinical diagnosis of hypercapnia and stage III or IV COPD (according to GOLD 2008 guidelines)
- Patient with stable COPD in the four weeks prior to selection as evidenced by no i.v. COPD medication, no treatment for COPD in an emergency, no acute intensive care setting, no intake of antibiotics and stables ph,
- Current or ex-smoker with a smoking history of 10 pack-years or more
- Patient used to supported Non-Invasive Ventilation (NIV),
- Patient willing an able to complete the requierments of the study in one month or less, including repeated pulmonary function tests and Six-Minute Walk Tests,
- Patient having dated and signed his/her written informed consent after full explanation of the study by the investigator, prior to study participation
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Inability or contra-indication to perform pulmonary function tests,
- Inability or contra-indication to perform the Six-Minute Walk Test with a trolley,
- Any contra-indication to receive Non-Invasive Ventilation (NIV),
- Obese patient having a Body Mass Index (BMI) < 35,
- Pregnant or lactating woman,
- Female patient of child-bearing potential with lack of efficient contraception (as defined in CPMP/ICH/286/95 guideline (note 3)),
- Unstable COPD or any other past or present significant respiratory disease,
- Clinically significant or uncontrolled pathologie conditions which may interfere with the study procedures or endager the patient,
- Drug abuse or psychic disorders resulting in the inability to fully understand the requirements of the study,
- Legal status which prohibitis informed consent,
- Participation in any interventional clinical trial within 30 days prior to selection or current participation in another investigational product trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the distance walked by severe COPD patients during a Six-Minute Walk Test while spontaneously breathing Helium/Oxygen (65%/35%) compared to either spontaneously breathing Nitrogen/Oxygen (65%/35%) or breathing Nitrogen/Oxygen (65%/35%) under Non-Invasive Ventilation (NIV) with an FIO2 of 0.35;Secondary Objective: - to evaluate exercise related symptoms,<br> - to measure pulmonary function parameters at rest,<br> - to assass the safety of the transmission of He/O2 (65%/35%) mixture;Primary end point(s): The primary efficacy criterion is the distance walked during a Six-Minute Walk Test while spontaneously breathing Helium/Oxygen (65%/35%) compared to either spontaneously breathing Nitrogen/Oxygen (65%/35%) or breathing Nitrogen/Oxygen (65%/35%) under Non-Invasive ventilation (NIV) with an FIO2 of 0.35I