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Trial registered on ANZCTR


Registration number
ACTRN12614000361606
Ethics application status
Approved
Date submitted
28/03/2014
Date registered
7/04/2014
Date last updated
16/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
High concentration oxygen in Chronic Obstructive Pulmonary Disease (COPD)
Scientific title
Response of Patients with COPD to Hyperoxia and Normoxia, as Measured by Carbon Dioxide Levels.
Secondary ID [1] 284321 0
Nil.
Universal Trial Number (UTN)
U1111-1150-9928
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COPD 291469 0
Condition category
Condition code
Respiratory 291836 291836 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
50% oxygen administration for 30 minutes via a full-face continuous positive airway pressure mask without positive airway pressure. Followed by a 30 minute washout period.
Intervention code [1] 289039 0
Treatment: Other
Comparator / control treatment
21% oxygen administration for 30 minutes via a full-face continuous positive airway pressure mask without positive airway pressure. Followed by a 30 minute washout period.
Control group
Placebo

Outcomes
Primary outcome [1] 291754 0
Transcutaneous carbon dioxide level, as measured by a TOSCA monitor.
Timepoint [1] 291754 0
30 minutes.
Secondary outcome [1] 307416 0
Transcutaneous carbon dioxide level, as measured by a TOSCA monitor.
Timepoint [1] 307416 0
10 and 20 minutes.
Secondary outcome [2] 307417 0
Respiratory rate, measured from capnography equipment.
Timepoint [2] 307417 0
10, 20 and 30 minutes.
Secondary outcome [3] 307418 0
Minute ventilation, calculated using data from a flow sensor attached to the expiratory port of the participant's mask.
Timepoint [3] 307418 0
10, 20 and 30 minutes.
Secondary outcome [4] 307419 0
Volume of dead space to tidal volume, calculated using data from a flow sensor attached to the expiratory port of the participant's mask and volumetric capnography.
Timepoint [4] 307419 0
10, 20 and 30 minutes.
Secondary outcome [5] 307420 0
Change in transcutaneous carbon dioxide greater than or equal to 4mmHg, as measured by the TOSCA monitor.
Timepoint [5] 307420 0
30 minutes.
Secondary outcome [6] 307421 0
Change in transcutaneous carbon dioxide greater than or equal to 10mmHg, as measured by the TOSCA monitor.
Timepoint [6] 307421 0
30 minutes.
Secondary outcome [7] 307422 0
Effect of baseline transcutaneous carbon dioxide (measured via TOSCA) and FEV1 (measured via spirometry) on outcomes.
Timepoint [7] 307422 0
Baseline.
Secondary outcome [8] 307423 0
Tidal volume, calculated using data from a flow sensor attached to the expiratory port of the participant's mask and volumetric capnography.
Timepoint [8] 307423 0
10, 20 and 30 minutes.
Secondary outcome [9] 307424 0
Volume of dead space, calculated using data from a flow sensor attached to the expiratory port of the participant's mask and volumetric capnography.
Timepoint [9] 307424 0
10, 20 and 30 minutes.
Secondary outcome [10] 307425 0
Alveolar volume, calculated using data from a flow sensor attached to the expiratory port of the participant's mask and volumetric capnography.
Timepoint [10] 307425 0
10, 20 and 30 minutes.
Secondary outcome [11] 307426 0
Alveolar minute ventilation, calculated using data from a flow sensor attached to the expiratory port of the participant's mask and volumetric capnography.
Timepoint [11] 307426 0
10, 20 and 30 minutes.
Secondary outcome [12] 307427 0
Oxygen saturations, as recorded on the TOSCA via continuous electronic recording data download.
Timepoint [12] 307427 0
Continuously over the timecourse of the intervention and washout period.
Secondary outcome [13] 307428 0
Heart rate, measured from the TOSCA.
Timepoint [13] 307428 0
10, 20 and 30 minutes.
Secondary outcome [14] 307429 0
Evaluation of outcomes above in comparason to results from a study of the same design in patients with bronchiectasis (ACTRN12612000356864).
Timepoint [14] 307429 0
Time points as above.

Eligibility
Key inclusion criteria
COPD, as diagnosed by a doctor.
Minimum age
16 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Baseline transcutaneous carbon dioxide of greater than or equal to 60mmHg
2. FEV1:FVC ratio >0.7
3. Age under 16 years
4. A diagnosis of bronchiectasis
5. Morbid obesity (with a body mass index of greater than or equal to 40)
6. Inability to match FEV1 percentage predicted to a participant that took part in the bronchiectasis oxygen study*
7. Any other condition which, at the investigator’s discretion, is believed may present a safety risk or impact the feasibility of the study or the study results.

*This study is designed to allow for comparison of results to a study of similar design in patients with bronchiectasis (ACTRN12612000356864). Participants will therefore be matched by FEV1 to the participants in the bronchiectasis study (the COPD participant must have an FEV1 percentage predicted within an absolute value of 5% of the FEV1 percentage predicted for the bronchiectasis patient (values inclusive)).

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)
Following explanation of the trial and consent, participants will be assessed for eligibility. If eligible, participants will be randomised to the order of interventions (21% oxygen and 50% oxygen). This order will be available to an investigator who is not administering treatment, assessing outcomes or analysing data. Their role is to make available the gas bottles and bags (containing either 21% oxygen or 50% oxygen) in the randomised order. The labels on the bottles will be covered to maintain blinding of other investigators and the participant.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
By computer.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Outcomes will be adjusted for baseline in the data analysis.
Phase
Not Applicable
Type of endpoint(s)
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 5919 0
New Zealand
State/province [1] 5919 0

Funding & Sponsors
Funding source category [1] 288958 0
Government body
Name [1] 288958 0
Health Research Council of New Zealand
Address [1] 288958 0
Level 3 - ProCARE Building, Grafton Mews, at 110 Stanley Street, Auckland 1010
Country [1] 288958 0
New Zealand
Funding source category [2] 288959 0
Charities/Societies/Foundations
Name [2] 288959 0
Medical Research Institute of New Zealand
Address [2] 288959 0
MRINZ, Wellington Regional Hospital, Riddiford Street, Newtown, Wellington 6021
Country [2] 288959 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Medical Research Institute of New Zealand
Address
MRINZ, Wellington Regional Hospital, Riddiford Street, Newtown, Wellington 6021
Country
New Zealand
Secondary sponsor category [1] 287637 0
None
Name [1] 287637 0
Nil.
Address [1] 287637 0
Country [1] 287637 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290769 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 290769 0
Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington 6011
Ethics committee country [1] 290769 0
New Zealand
Date submitted for ethics approval [1] 290769 0
Approval date [1] 290769 0
24/12/2013
Ethics approval number [1] 290769 0
13/STH/200

Summary
Brief summary
Oxygen may have the side effect of increasing the concentration of carbon dioxide in the blood. Carbon dioxide is a waste product that is removed from the body through the lungs. This side effect is known to occur in patients with COPD. To help understand how to best administer oxygen to patients we are interested in understanding how this effect occurs. We are also interested in whether patients with COPD have a different response to oxygen therapy compared with patients with other respiratory diseases (including bronchiectasis).

To investigate this we will measure carbon dioxide levels in people with COPD while breathing room air and compare them to carbon dioxide levels after they have breathed oxygen.

Following consent and assessment for eligibility, participants will be asked to breathe in random order treatment A (oxygen for 30 minutes) and treatment B (normal room air for 30 minutes) through a mask.
Participants will be randomly assigned to either receive treatment A then treatment B, or treatment B then treatment A.

Carbon dioxide is easily measured during the interventions using a small device clipped painlessly to the earlobe. This will allow for continuous monitoring of carbon dioxide levels by a study doctor The results of this study will then be compared with those from our recently completed study of oxygen in patients with bronchiectasis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 47202 0
Dr Janine Pilcher
Address 47202 0
MRINZ, Wellington Regional Hospital, Riddiford Street, Newtown, Wellington, 6021
Country 47202 0
New Zealand
Phone 47202 0
+64 4 8050241
Fax 47202 0
Email 47202 0
janine.pilcher@mrinz.ac.nz
Contact person for public queries
Name 47203 0
Dr Janine Pilcher
Address 47203 0
MRINZ, Wellington Regional Hospital, Riddiford Street, Newtown, Wellington, 6021
Country 47203 0
New Zealand
Phone 47203 0
+64 4 8050241
Fax 47203 0
Email 47203 0
janine.pilcher@mrinz.ac.nz
Contact person for scientific queries
Name 47204 0
Dr Janine Pilcher
Address 47204 0
MRINZ, Wellington Regional Hospital, Riddiford Street, Newtown, Wellington, 6021
Country 47204 0
New Zealand
Phone 47204 0
+64 4 8050241
Fax 47204 0
Email 47204 0
janine.pilcher@mrinz.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary