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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/NCT05169723




Registration number
NCT05169723
Ethics application status
Date submitted
8/12/2021
Date registered
27/12/2021
Date last updated
28/04/2022

Titles & IDs
Public title
Respiratory Emissions in Healthy Participants
Scientific title
Respiratory Emissions in Healthy Participants
Secondary ID [1] 0 0
CIA-292
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - Exertional respiratory activities

Experimental: Respiratory Activity 1 -

Experimental: Respiratory Activity 2 -

Experimental: Respiratory Activity 3 -

Experimental: Respiratory Activity 4 -

Experimental: Respiratory Activity 5 -


Behaviour: Exertional respiratory activities
participants will perform a series of exertional respiratory activities
Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Count of total number of respiratory particles emitted during respiratory activities in the range of 0.3 to 25 microns
Timepoint [1] 0 0
Emission of particles will be collected and analysed for 2 minutes during each experimental condition

Eligibility
Key inclusion criteria
- Adults, over the age of 18 and able to give informed consent

- Symptom free from any respiratory illness in the last 48 hours
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Pregnant (where the participant feels that their pregnancy will make participation
uncomfortable)

- Inability to give consent

- Current respiratory disease. Participants with well controlled asthma will be included
(defined as asthma that the participant self-rates their asthma as being under control
and that does not limit exercise, work)

Study design
Purpose of the study
Basic Science
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
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/03/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2023
Actual
Sample size
Target
85
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Fisher and Paykel Healthcare
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is an randomised cross over trial in healthy participants measuring respiratory
emissions during different respiratory activities.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05169723
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/NCT05169723