Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000487314
Ethics application status
Approved
Date submitted
22/09/2008
Date registered
30/09/2008
Date last updated
20/10/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Breathe easier during exercise ~ Can Heliox improve the sensation of breathlessness and increase exercise duration in people with COPD
Scientific title
Can Heliox improve the sensation of breathlessness and increase exercise duration in chronic obstructive pulmonary disease; A prospective randomized trial.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease (COPD) 3661 0
Dyspnoea 3662 0
Condition category
Condition code
Respiratory 3829 3829 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Heliox (21% oxygen in balance Helium) Heliox will only be administered during one cardio pulmonary exercise test, at a predetermined constant work rate, until exhaustion. (anticipated to be no more than 45 mins total duration). Heliox will be stored in a large non diffusing reservoir bag from where it will pass through a humidifier prior to inhalation by the patient through a face mask/mouth piece
Intervention code [1] 3378 0
Rehabilitation
Comparator / control treatment
Medical/Room Air. This comparator gas will only be administered during one cardio pulmonary exercise test, at a predetermined constant work rate, until exhaustion. (anticipated to be no more than 45 mins total duration). It will be stored in a large non diffusing reservoir bag from where it will pass through a humidifier prior to inhalation by the patient through a face mask/mouth piece
Control group
Active

Outcomes
Primary outcome [1] 4804 0
Perception of Dyspnoea (Intensity & Qualitative Sensations). This outcome will be measured through pre validated language of breathlessness interviews (recalled and current sensations), Visual Analogue Scale (VAS) intensity scales and also a pre validated dyspnoea list of descriptor statements (Maher et al 1996). Individualised dyspnoea descriptor lists will be generated for each patient drawn from responses obtained during the language of breathless interview.
Timepoint [1] 4804 0
Intensity and sensations of breathlessness will be recorded in real time, by selecting from the predetermined and individualised dyspnoea descriptor list, at regular intervals (every 2 minutes) during constant rate exercise tests.
Secondary outcome [1] 8108 0
Perception of Muscle Fatigue (Intensity) This outcome will be measured using the prevalidated 100 point VAS scale.
Timepoint [1] 8108 0
Perception of muscle fatigue will be recorded in real time at regular intervals (every 2 minutes) during constant rate exercise tests.
Secondary outcome [2] 8109 0
Exercise Ventilatory Parameters. These outcomes, including Oxygen Uptake (VO2max), Ventilation rates, Tidal Volumes, Inspiratory Reserve Volumes (IRV), End Inspiratory Lung Volumes (EILV), Inspiratory & Expiratory times (TI & TE), Oxygen Saturation (SpO2), Heart Rate (HR) & Blood Pressure (BP) will be acquire in real time from samples of analysed exhaled breath (Viasys Jaeger Oxycon Delta).
Timepoint [2] 8109 0
Analysis of these ventilatory parameters will be recorded in real time allowing for set isotime points to be isolated and statistically analysed. It is currently proposed that this data be analysed every two minutes during constant rate exercise tests.

Eligibility
Key inclusion criteria
Are aged over 40

Chronic Obstructive Pulmonary Disease (COPD) of at least Stage III as per the Global initiative for chronic Obstructive Lung Disease (GOLD) guidelines, Forced Expiratory Volume in the first second (FEV1) <= 50% predicted post bronchodilator.

Are able to give informed written consent prior to entering the study.

Can comply with scheduled visit and all study related activities
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any clearly documented history of adult asthma or chronic respiratory disorders (e.g. primary bronchiectasis, pulmonary fibrosis or any clearly documented history of adult asthma or chronic respiratory disorders (e.g. primary bronchiectasis, pulmonary fibrosis, pneumoconiosis) other than COPD.

Any contraindication for Cardio Pulmonary Exercise Testing (CPET), as per American Thoracic Society and American College of Chest Physicians guidelines (ATS/ACCP 2003)

Participating in a research study or use of any investigational drug during this studys, pneumoconiosis) other than COPD.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All patients will be enrolled with sequential numbers, a preprepared randomization list will be used to assign treatment arms.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A preprepared computerized list will bve generated as a randomization schedule.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3844 0
Hospital
Name [1] 3844 0
Department of Respiratory Medicine, Repatriation General Hospital.
Country [1] 3844 0
Australia
Primary sponsor type
Hospital
Name
Department of Respiratory Medicine, Repatriation General Hospital
Address
Daws Road
Daw Park
South Australia 5041
Country
Australia
Secondary sponsor category [1] 3509 0
University
Name [1] 3509 0
School of Health Sciences, University of South Australia
Address [1] 3509 0
City East Campus
North Terrace
Adelaide
South Australia 5000
Country [1] 3509 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5896 0
Repatriation General Hospital's Human Research & Ethics Committee
Ethics committee address [1] 5896 0
Daws Road, Daw Park, South Australia 5041
Ethics committee country [1] 5896 0
Australia
Date submitted for ethics approval [1] 5896 0
28/08/2008
Approval date [1] 5896 0
Ethics approval number [1] 5896 0
48/08
Ethics committee name [2] 5970 0
University of South Australia's Human Research & Ethics Committee
Ethics committee address [2] 5970 0
University of South Australia
Mawson Lakes Campus
Mawson Lakes Boulevard
Mawson Lakes SA 5095
Ethics committee country [2] 5970 0
Australia
Date submitted for ethics approval [2] 5970 0
08/09/2008
Approval date [2] 5970 0
Ethics approval number [2] 5970 0
P248/08

Summary
Brief summary
Distress with breathing or shortness of breath can be a debilitating experience for people suffering from lung diseases. The severity of this sensation often precludes individuals from maintaining a normal active lifestyle. As the severity of the shortness of breath increases, so the activity performed decreases, often to the point where moving from one’s bed or chair can be exhausting. The general physical and mental health consequences of this are such that these individuals and those who care for them have a significantly lower social and mental health well being. The severity of breathlessness and impairment of activity have been shown to correlate strongly with increased hospitalizations and a longer time to recovery once their condition has worsened, as in the case of exacerbations.

It is hoped that a low density gas mix, such as Heliox (21 % oxygen in balance Helium), can reduce the magnitude of muscular effort associated with breathing in patients with chronic obstructive pulmonary diseases (COPD) and allow for an alteration in both the sensation and magnitude of dyspnoea allowing patients to exercise longer and at greater intensities., thus facilitating a training effect. This would allow these individuals to improve their social activity, mental health and their quality of life whilst reducing the recovery time resultant from a transient worsening of their conditions (infective exacerbations of COPD) which may have otherwise predisposed hospitalization.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28915 0
Address 28915 0
Country 28915 0
Phone 28915 0
Fax 28915 0
Email 28915 0
Contact person for public queries
Name 12072 0
Toby Hunt
Address 12072 0
c/o Respiratory Clinical Trials
Repatriation General Hospital
Daws Road Daw Park
South Australia 5041
Country 12072 0
Australia
Phone 12072 0
+61 8 8275 1008
Fax 12072 0
+61 8 8275 1195
Email 12072 0
[email protected]
Contact person for scientific queries
Name 3000 0
Toby Hunt
Address 3000 0
c/o Respiratory Clinical Trials
Repatriation General Hospital
Daws Road Daw Park
South Australia 5041
Country 3000 0
Australia
Phone 3000 0
+61 8 8275 1008
Fax 3000 0
+61 8 8275 1195
Email 3000 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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