Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01906931




Registration number
NCT01906931
Ethics application status
Date submitted
16/07/2013
Date registered
24/07/2013
Date last updated
25/06/2014

Titles & IDs
Public title
Ambulatory Oxygen for ILD
Scientific title
Effective Delivery of Ambulatory Oxygen in Interstitial Lung Disease - a Crossover Trial.
Secondary ID [1] 0 0
187_13
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Interstitial Lung Disease 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Portable oxygen concentrator
Treatment: Devices - Portable oxygen cylinder

Experimental: Portable Oxygen Concentrator first -

Active Comparator: Portable oxygen cylinder first -


Treatment: Devices: Portable oxygen concentrator
Respironics EverGo portable oxygen concentrator on setting 6

Treatment: Devices: Portable oxygen cylinder
Portable oxygen cylinder at flow rate 5 Litres/min
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Nadir SpO2
Timepoint [1] 0 0
During 6-min walk test with each oxygen delivery device
Secondary outcome [1] 0 0
6-min walk distance
Timepoint [1] 0 0
End 6-min walk test with each oxygen delivery device
Secondary outcome [2] 0 0
Borg dyspnoea score
Timepoint [2] 0 0
End 6-min walk test with each oxygen delivery device
Secondary outcome [3] 0 0
Borg fatigue score
Timepoint [3] 0 0
End 6-min walk test with each oxygen delivery device
Secondary outcome [4] 0 0
Partial pressure of oxygen in arterial blood (PaO2) at rest
Timepoint [4] 0 0
Prior to 6-min walk test with each oxygen delivery device
Secondary outcome [5] 0 0
Proportion of participants who desaturate to less than 80%
Timepoint [5] 0 0
During 6-min walk test on each oxygen delivery device

Eligibility
Key inclusion criteria
- a confident diagnosis of ILD made according to established criteria and

- desaturate to less than 90% during a 6-minute walk test
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- primary diagnosis of a respiratory condition other than ILD (eg COPD)

- currently using continuous oxygen therapy

- oxyhaemoglobin saturation (SpO2) is less than 90% on room air

- unable to perform a 6-minute walk test or comorbidities that limit walking

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2014
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Anne Holland
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Alfred
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
People with interstitial lung disease (ILD) are frequently prescribed ambulatory oxygen, to
increase oxygen levels in the blood during daily activities. The best way of delivering this
type of oxygen has not been established. The aim of this study is to compare two devices for
delivering oxygen in people with interstitial lung disease - the traditional method using
portable cylinders and a newer method using a portable concentrator. The investigators
hypothesise that oxygen levels during exercise will be significantly higher when using a
portable cylinder, but this difference will be small.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01906931
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01906931