Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000891820
Ethics application status
Approved
Date submitted
25/05/2021
Date registered
8/07/2021
Date last updated
28/10/2022
Date data sharing statement initially provided
8/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot study on the effect of ozone exposure on lung function
Scientific title
Pilot study determining the concentration of acute ozone exposure that induces lung inflammation in healthy volunteers
Secondary ID [1] 304309 0
None
Universal Trial Number (UTN)
U1111-1266-9868
Trial acronym
Linked study record
Pilot study for "The effect of BerriQi® Boysenberry and apple product on lung function following ozone exposure" (ACTRN12621000774820)

Health condition
Health condition(s) or problem(s) studied:
reduced lung function 322049 0
lung inflammation 322050 0
Condition category
Condition code
Respiratory 319774 319774 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 319775 319775 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will be exposed to ozone at a set concentration within a controlled environment for 2 hours to induce acute lung inflammation. During the 2 hours the participants will be asked to perform a moderate cycling exercise at the intensity corresponding to 30-40 L/min of their VEmin. The duration of the cycle exercise will last for 2 hours and will be broken up in intervals of 15 minutes cycling followed by 15 minutes of rest. Each participant will be exposed to a single, steady-state ozone concentration for 2 hours.
The ozone concentration within the chamber will be either 0.1, 0.2, and 0.3 ppm. The first cohort of 2 participants will be exposed to 0.1ppm ozone for 2 hours, the next cohort of 2 participants will be exposed to 0.2ppm ozone for 2 hours and so on.
Intervention code [1] 320650 0
Lifestyle
Comparator / control treatment
All changes in lung function and inflammatory status will be compared to the individual's baseline (prior to ozone exposure and exercise) measurements. The comparator measurements will be taken immediately prior to the ozone exposure.
Control group
Dose comparison

Outcomes
Primary outcome [1] 327633 0
Exhaled nitric oxide (FeNO) will be measured using an exhaled nitric oxide detector that participants breath into to measure nitric oxide in their breath. Nitric oxide is a gas produced by cells involved in inflammation and an increase of 10% (10ppb) from baseline is considered to be a clinically relevant indicator of lung inflammation.
Timepoint [1] 327633 0
Baseline, immediately post (0h) and 2 (primary timepoint), 24h and 48h post ozone exposure
Primary outcome [2] 327634 0
Forced expiratory volume in 1 minute (FEV1) and forced vital capacity (FVC) will be measured using a clinical spirometer to assess these clinically relevant parameters of participant’s lung function. This is a composite measurement.
Timepoint [2] 327634 0
Baseline, immediately post (0h) and 2 (primary timepoint), 24h and 48h post ozone exposure
Secondary outcome [1] 396002 0
Plasma cytokine concentrations (IL-4, IL-2, CXCL10 (IP-10), IL-1ß, TNF-a, CCL2 (MCP-1), IL-17A, IL-6, IL-10, IFN-g, IL-12p70, CXCL8 (IL-8), TGF-ß1) will be assayed using a bead-based multiplex panel (LEGENDplex™ Human Essential Immune Response Panel (13-plex)) and measured using flow cytometry.
Timepoint [1] 396002 0
Baseline, immediately post (0h) and 2, 24h and 48h post ozone exposure
Secondary outcome [2] 396003 0
White blood cells from venous blood samples will stained with fluorophore-conjugated antibodies to identify granulocytes, monocytes and lymphocytes by flow cytometry. This is a composite measurement
Timepoint [2] 396003 0
Baseline, immediately post (0h) and 2, 24h and 48h post ozone exposure
Secondary outcome [3] 396004 0
plasma samples will be used to determine oxidative potential (OPA)
Timepoint [3] 396004 0
Baseline, immediately post (0h) and 2, 24h and 48h post ozone exposure
Secondary outcome [4] 396005 0
plasma samples will be used to determine malondialdehyde (MDA) concentration
Timepoint [4] 396005 0
Baseline, immediately post (0h) and 2, 24h and 48h post ozone exposure
Secondary outcome [5] 396006 0
plasma samples will be used to determine protein carbonyls concentration
Timepoint [5] 396006 0
Baseline, immediately post (0h) and 2, 24h and 48h post ozone exposure
Secondary outcome [6] 396007 0
Subjective lung health will be assessed by asking participants to complete the Chronic Respiratory Questionnaire
Timepoint [6] 396007 0
Baseline, immediately post (0h) and 2h, 24h 48h and one week post ozone exposure
Secondary outcome [7] 396008 0
Subjective lung health will be assessed by asking participants to respond to lung health symptom scores (VAS)
Timepoint [7] 396008 0
Baseline, immediately post (0h) and 2h, 24h 48h and one week post ozone exposure

Eligibility
Key inclusion criteria
Healthy male and female (50/50) non-pregnant individuals 18-40 years of age with normal lung function at baseline will be selected
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
If they are unwilling or unable to provide informed written consent or comply with the study procedures.
• If they have a diagnosed health conditions that impair their lung function (asthma, COPD, fibrosis), diabetes or cardiovascular disease.
• If they smoke.
If they work in an environment where they are exposed to high levels of occupational respiratory irritants such as ozone or fine particulate matter (eg welders)
In addition, participants will also be excluded if they have the following health conditions: (i) blood borne diseases (e.g. hepatitis), (ii) clinically diagnosed high/low blood pressure, (iii) recent bacterial or viral illness or (iv) are taking medication that affects the properties of blood (e.g. blood clotting)

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed, all participants will receive the intervention
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Power analysis of previous studies indicate that in order to show that ozone exposure has significantly changed respiratory function from baseline/prior to ozone exposure (one sample, one sided t-test, with 80% power) we need n=12 per group. However, because of the stepwise ozone concentration increases needed to determine the most effective concentration, we intend to recruit 20 participants for the pilot study. This will ensure that even if we need to increase the ozone concentration to 0.3ppm to see the desired effect on respiratory function we will still have a minimum of 12 participants exposed to the same ozone concentration for the subsequent power analysis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
17/10/2022
Actual
Date of last participant enrolment
Anticipated
30/11/2022
Actual
Date of last data collection
Anticipated
9/12/2022
Actual
Sample size
Target
20
Accrual to date
0
Final
Recruitment outside Australia
Country [1] 23721 0
New Zealand
State/province [1] 23721 0
Palmerston North, Manawatu

Funding & Sponsors
Funding source category [1] 308683 0
Government body
Name [1] 308683 0
High Value Nutrition National Science Challenge
Country [1] 308683 0
New Zealand
Primary sponsor type
Government body
Name
The New Zealand Institute for Plant and Food Research
Address
Private Bag 11600,
Palmerston North 4442,
New Zealand
Country
New Zealand
Secondary sponsor category [1] 309563 0
University
Name [1] 309563 0
Massey University, Palmerston North
Address [1] 309563 0
School of Sport Exercise Nutrition Massey University Private Bag 11-222 Palmerston North 4442 New Zealand
Country [1] 309563 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308605 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 308605 0
Ethics committee country [1] 308605 0
New Zealand
Date submitted for ethics approval [1] 308605 0
16/10/2021
Approval date [1] 308605 0
14/07/2022
Ethics approval number [1] 308605 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111302 0
Dr Odette Shaw
Address 111302 0
The New Zealand Institute for Plant and Food Research Ltd. Private Bag 11600 Palmerston North 4442
Country 111302 0
New Zealand
Phone 111302 0
+64 06 355 6163
Fax 111302 0
Email 111302 0
[email protected]
Contact person for public queries
Name 111303 0
Dominic Lomiwes
Address 111303 0
The New Zealand Institute for Plant and Food Research Ltd. Private Bag 11600 Palmerston North 4442
Country 111303 0
New Zealand
Phone 111303 0
+64 06 3556113
Fax 111303 0
Email 111303 0
[email protected]
Contact person for scientific queries
Name 111304 0
Odette Shaw
Address 111304 0
The New Zealand Institute for Plant and Food Research Ltd. Private Bag 11600 Palmerston North 4442
Country 111304 0
New Zealand
Phone 111304 0
+64 06 355 6163
Fax 111304 0
Email 111304 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: To protect individual participants privacy individual's data will not be made available



What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17490Ethical approval    Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.