Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001285943
Ethics application status
Approved
Date submitted
28/11/2011
Date registered
15/12/2011
Date last updated
3/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Oxygen with exercise in idiopathic interstitial pneumonia
Scientific title
In patients with idiopathic interstitial pneumonia, giving supplemental oxygen during exercise improves endurance and pulmonary haemodynamics
Secondary ID [1] 273195 0
Nil
Universal Trial Number (UTN)
U1111-1125-1907
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic interstitial pneumonia 278947 0
Condition category
Condition code
Respiratory 279127 279127 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Supplemental oxygen either 35% through a venturi mask, or 60% through a breathing circuit.

A venturi mask, also known as an air-entrainment mask, is a medical device worn over the mouth and nose, that delivers a known oxygen concentration to patients. It is attached via long tubing to an oxygen cylinder during the endurance shuttle walk testing.

The breathing circuit is routinely used in cardiopulmonary exercise testing on a stationary bike, allowing investigators to measure oxygen uptake and expired carbon dioxide. It is also a convenient way of delivering supplemental oxygen during such testing. It has a mouthpiece much like scuba diving apparatus and is secured to the patient via a support frame over the head.

These two devices will only be worn during the exercise tests, (10 to 30 minutes in duration).

As per trial protocol, this is a crossover study, where each individual will perform 2 endurance shuttle walk tests (1 on oxygen via venturi mask, the other on air (sham) via venturi mask). The same individuals will also perform 2 maximal exercise tests on a stationary bike (1 on oxygen via breathing circuit, the other on air (sham) via breathing circuit). Crossover from intervention to placebo or vice versa will occur not less than 24 hours apart, and not greater than 28days apart. The washout period required for supplemental oxygen is only 15 to 20 minutes, but the 24 hours between testing is to allow complete recovery from the exercise itself.
Intervention code [1] 269521 0
Treatment: Other
Comparator / control treatment
The control arm will involve giving air through the same devices (venturi mask and breathing circuit). There will be no way for the subject to determine if they are breathing oxygen or air. There will be no difference in test procedures between intervention and control. The air is a placebo or sham intervention, because there is no physiologic difference between breathing air with or without a mask (or breathing circuit). This arm of the study is to assess the subjects' performance unaided, versus the active arm which involves the addition of oxygen.
Control group
Placebo

Outcomes
Primary outcome [1] 286030 0
The primary end-point in this study will be endurance exercise time measured at the endurance shuttle walk test (ESWT).
Timepoint [1] 286030 0
Test day 1 versus Test day 2 (oxygen versus placebo, random order, double-blinded)
- these two test days will be between 1 and 28 days apart.
Secondary outcome [1] 295235 0
Maximal oxygen consumption during maximal exercise testing
Timepoint [1] 295235 0
Measured during maximal exercise testing on two separate days (with no more than 4 weeks between these two days)
Secondary outcome [2] 295236 0
Endurance exercise time
Timepoint [2] 295236 0
Measured at the end of endurance shuttle walk testing on each of two separate days (with no more than 4 weeks between these two days)
Secondary outcome [3] 295237 0
Borg dyspnoea scale
Timepoint [3] 295237 0
Measured at the end of endurance shuttle walk testing on two separate days, as well as at the end of maximal exercise testing on two separate days
Secondary outcome [4] 295238 0
Pulmonary blood flow (a surrogate marker of strain on the heart) will be measured via the Innocor inert gas rebreathing device.
Timepoint [4] 295238 0
This will be measured at 3 minute intervals during the maximal exercise testing
Secondary outcome [5] 295239 0
Brain natriuretic peptide (BNP) - a surrogate marker of strain on the heart found in the blood, will be measured.
Timepoint [5] 295239 0
Blood samples for BNP will be collected at baseline and in the first minute of recovery following maximal exercise testing

Eligibility
Key inclusion criteria
Patients 18 - 80 yrs.
Patients able to perform exercise test as determined following clinical assessment.
Patients who desaturate to < 88% during a 6 minute walk test (6MWT)
Patients able to give informed consent.
Patients with idiopathic interstitial pneumonia (IIP), according to American Thoracic Society /European Respiratory Society criteria.
Absence of daytime resting hypoxaemia (ie with PaO2 > 55mmHg).
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients not able to give informed consent.
Patients considered unable to complete exercise test by their physician.
Presence of daytime resting hypoxaemia (PaO2 less than or equal to 55mmHg).
Presence of hypercapnia (PaCO2 > 45mmHg) at baseline
Patients with absolute contraindications to exercise testing including:

Aortic aneursym
Current viral illness
Unstable angina/acute ECG changes of ischaemia.
Myocardial infarction within the last 4 weeks.
Severe hypertension (systolic >240 mmHg; diastolic >120 mmHg).
Poorly controlled heart failure.
Myocarditis.
Exacerbation of asthma.
Severe aortic stenosis.
Acute pulmonary embolus / thrombus / venous thromboembolic disorders.
Pulmonary oedema.
Mental Impairment

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)
Subjects will be enrolled following a visit to the outpatient Interstitial Lung Disease Clinic, determination of suitability, and informed consent.
Allocation concealment shall be achieved by sequentially numbered opaque sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be via a computer generated
randomised permuted block sequence with a variable block size
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
1/01/2012
Actual
10/09/2012
Date of last participant enrolment
Anticipated
Actual
20/04/2016
Date of last data collection
Anticipated
Actual
27/04/2016
Sample size
Target
22
Accrual to date
Final
18
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 11580 0
Royal Prince Alfred Hospital - Camperdown

Funding & Sponsors
Funding source category [1] 284273 0
Hospital
Name [1] 284273 0
Royal Prince Alfred Hospital
Country [1] 284273 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital
Address
Missenden Rd, Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 283224 0
None
Name [1] 283224 0
Address [1] 283224 0
Country [1] 283224 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286233 0
Royal Prince Alfred Ethics Review Committee
Ethics committee address [1] 286233 0
Research Development Office
Missenden Rd
Royal Prince Alfred Hospital
Camperdown NSW 2050
Ethics committee country [1] 286233 0
Australia
Date submitted for ethics approval [1] 286233 0
09/11/2011
Approval date [1] 286233 0
08/12/2011
Ethics approval number [1] 286233 0
HREC/11/RPAH508

Summary
Brief summary
This is a study looking at exercise physiology in people with lung fibrosis. In particular, investigators are interested in the role of oxygen in exercise endurance, maximal exercise levels, and in its effect on reducing strain on the heart.

Participants will perform endurance exercise tests and maximal exercise testing on both air and oxygen. The hypothesis is that oxygen will improve endurance and reduce strain on the heart. This study will form the basis for future trials that examine the benefits of supplemental oxygen over longer periods.
Trial website
Trial related presentations / publications
Abstract/ Oral presentation 2017: Thoracic Society of Australia and New Zealand Meeting "Oxygen attenuates oxidative stress in ILD patients with nocturnal and exercise-induced hypoxaemia"
Public notes

Contacts
Principal investigator
Name 33254 0
Dr Lauren Troy
Address 33254 0
Department of Respiratory Medicine, Royal Prince Alfred Hospital
155 Missenden Rd Camperdown, NSW 2050
Country 33254 0
Australia
Phone 33254 0
+612 95158296
Fax 33254 0
Email 33254 0
ltroy@med.usyd.edu.au
Contact person for public queries
Name 16501 0
Dr Lauren Troy
Address 16501 0
Department of Respiratory Medicine
Royal Prince Alfred Hospital
Missenden Rd
Camperdown
NSW 2050
Country 16501 0
Australia
Phone 16501 0
+61295156111
Fax 16501 0
Email 16501 0
ltroy@med.usyd.edu.au
Contact person for scientific queries
Name 7429 0
Dr Lauren Troy
Address 7429 0
Department of Respiratory Medicine
Royal Prince Alfred Hospital
Missenden Rd
Camperdown
NSW 2050
Country 7429 0
Australia
Phone 7429 0
+61295156111
Fax 7429 0
Email 7429 0
ltroy@med.usyd.edu.au

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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