Trial registered on ANZCTR


Trial ID
ACTRN12611001154998
Ethics application status
Approved
Date submitted
2/11/2011
Date registered
3/11/2011
Date last updated
8/01/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Does supplemental oxygen reduce exercise induced oxidative stress in idiopathic pulmonary fibrosis?
Scientific title
Does supplemental oxygen reduce exercise induced oxidative stress in idiopathic pulmonary fibrosis?
Secondary ID [1] 273312 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic pulmonary fibrosis 279085 0
Condition category
Condition code
Respiratory 279274 279274 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised to receive either supplemental oxygen or compressed air for one hour at rest then they will subsequently perform a constant cycle endurance test at 85% of the peak work rate achieved on a cardiopulmonary exercise test receiving the same intervention (oxygen or air). One week later participants will repeat the protocol, receiving the opposite intervention to their previous visit.


Oxygen supplementation and compressed air will be supplied at rest and during exercise via a venturi mask. Oxygen will be supplied at a FiO2 of 0.30. The mask and gas flow will be set up by an unblinded investigator and the oxygen and air flow meters will be screened so that the researcher conducting the exercise tests is unaware of the gas allocation. This investigator will also monitor SpO2 throughout the test and will notify the researcher conducting the test if SpO2 drops below 80%.
Intervention code [1] 283662 0
Prevention
Intervention code [2] 283670 0
Treatment: Other
Comparator / control treatment
Each participant will act as their own control receiving both interventions -oxygen and air. The participant will be blinded to what intervention they are receiving.
Control group
Placebo

Outcomes
Primary outcome [1] 279893 0
Endurance time - Length of time on the cycle endurance test. Participants are instructed to pedal for as long as possible at a fixed workrate.
Timepoint [1] 279893 0
Post cycle endurance test
Primary outcome [2] 279894 0
Oxidative stress - Plasma concentrations of F2-isoprostanes and Thiobarbiuric acid reactive substances (TBARs)
Timepoint [2] 279894 0
Pre and post 1 hour of treatment at rest
Post cycle endurance test
1 and 24 hours post cycle endurance exercise test.
Secondary outcome [1] 294714 0
Systemic Inflammation - Plasma concentrations of the cytokines IL-6 and tumor necrosis factor-a
Timepoint [1] 294714 0
Pre and post 1 hour of treatment at rest
Post cycle endurance test
1 and 24 hours post cycle endurance exercise test.
Secondary outcome [2] 294715 0
Skeletal muscle metabolism - Plasma concentrations of xanthine, hypoxanthine, uric acid, lactate and creatine kinase
Timepoint [2] 294715 0
Pre and post 1 hour of treatment at rest
Post cycle endurance test
1 and 24 hours post cycle endurance exercise test.

Eligibility
Key inclusion criteria
Patients with a documented diagnosis of idiopathic pulmonary fibrosis
Minimum age
30 Years
Maximum age
90 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who
1. are clinically unstable
2. have a history of syncope on exertion
3. have a concurrent and predominant diagnosis of another significant respiratory disorder (e.g. non-IPF interstitial lung disease, asthma, chronic obstructive pulmonary disease [COPD], bronchiectasis, cystic fibrosis, or lung carcinoma)
4. have any significant co-morbidities which preclude exercise or would prevent them from completing the exercise test protocol.
5. have a resting SpO2 less than or equal to 85% on room air

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes containing group allocation will be opened by an individual who will not be conducting any of the exercise tests
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization by using a computer generated list of random numbers
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
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Current
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284144 0
Government body
Name [1] 284144 0
National Health and Medical Research Council (NHMRC)
Address [1] 284144 0
GPO Box 1421
Canberra
ACT 2601
Country [1] 284144 0
Australia
Primary sponsor type
Individual
Name
Leona Dowman
Address
La Trobe University/Alfred Health Clinical School
Level 4, The Alfred Centre
99 Commercial Road
Prahran
VICTORIA 3181
Country
Australia
Secondary sponsor category [1] 269107 0
University
Name [1] 269107 0
La Trobe University
Address [1] 269107 0
c/- La Trobe / Alfred Health Clinical School
Level 4, The Alfred Centre
99 Commercial Road
Prahran
VICTORIA 3181
Country [1] 269107 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 272106 0
Austin Health Human Research Ethics Commitee
Ethics committee address [1] 272106 0
Studley Rd
Heidelberg
Victoria 3084
Ethics committee country [1] 272106 0
Australia
Date submitted for ethics approval [1] 272106 0
28/11/2011
Approval date [1] 272106 0
04/07/2012
Ethics approval number [1] 272106 0

Summary
Brief summary
Idiopathic pulmonary fibrosis (IPF) is a progressive and disabling lung disease characterized by significant dyspnoea and fatigue, reduced exercise tolerance and has a poor prognosis. Oxidative stress is a prominent feature of IPF, which is increased during exercise. This increased oxidant burden during exercise is accompanied by hypoxemia and an impaired metabolic response which may contribute to skeletal muscle dysfunction and limit exercise endurance in patients with IPF. Currently there is no evidence regarding the effect of supplemental oxygen on exercise induced oxidative stress in patients with IPF, despite several studies showing promising outcomes in patients with COPD . The primary aim of this study is to identify whether supplemental oxygen is successful in reducing exercise induced oxidative stress in IPF and whether it plays a role in attenuating impaired skeletal muscle metabolism leading to an improvement in exercise tolerance.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33342 0
Prof Christine McDonald
Address 33342 0
Department of Respiratory and Sleep Medicine
Austin Health
PO Box 5555
Heidelberg
Vic 3084
Country 33342 0
Australia
Phone 33342 0
+612 9496 5787
Fax 33342 0
Email 33342 0
christine.mcdonald@austin.org.au
Contact person for public queries
Name 16589 0
Ms Leona Dowman
Address 16589 0
La Trobe / Alfred Health Clinical School
Level 4, The Alfred Centre
99 Commercial Road
Prahran
VICTORIA 3181
Country 16589 0
Australia
Phone 16589 0
+ 61 3 9749 6747
Fax 16589 0
+ 61 3 9533 2104
Email 16589 0
leona.dowman@austin.org.au
Contact person for scientific queries
Name 7517 0
Ms Leona Dowman
Address 7517 0
La Trobe / Alfred Health Clinical School
Level 4, The Alfred Centre
99 Commercial Road
Prahran
VICTORIA 3181
Country 7517 0
Australia
Phone 7517 0
+ 61 3 9749 6747
Fax 7517 0
+ 61 3 9533 2104
Email 7517 0
leona.dowman@austin.org.au