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Trial registered on ANZCTR


Registration number
ACTRN12616000603415
Ethics application status
Approved
Date submitted
23/02/2016
Date registered
10/05/2016
Date last updated
10/05/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
The utility of alternative spirometry measurements and the variability of each for assessing bronchodilator response
Scientific title
The utility of pulmonary function parameters in addition to FEV1 (forced expiratory volume in one second) and FVC (forced vital capacity) and the variability of each for assessing the reversibility of airway obstruction in adults undergoing bronchodilator response testing
Secondary ID [1] 288354 0
Nil known
Universal Trial Number (UTN)
U1111-1178-6912
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Reversibility of airway obstruction 297348 0
Condition category
Condition code
Respiratory 297539 297539 0 0
Asthma
Respiratory 297540 297540 0 0
Chronic obstructive pulmonary disease
Respiratory 297541 297541 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will rate their current level of breathlessness and perform slow spirometry manoeuvres in addition to the forced spirometry manoeuvres that have been requested as part of their clinical care. A forced spirometry manoeuvre is a complete inspiration, followed by a maximal effort, sharp, complete expiration, and is completed by a fast and full inspiration. A slow spirometry manoeuvre is the same sequence of breathing without using maximal force. Where time permits, this sequence will be repeated after a 30 minute wait. The repetition of this sequence is additional to the patient's standard care. As part of standard clinical care spirometry will then be repeated 15 minutes after administration of 400mcg Salbutamol via a metered dose inhaler and spacer. The patient's level of breathlessness will be reassessed at this point. Participants will also answer two short respiratory questionnaires. Total standard testing time is 45 minutes and the additional manoeuvres will add approximately 15 minutes to the appointment time, making total participation one hour. The questionnaires will not add time to the appointment as they will be answered during the standard 15 minute wait time after bronchodilator administration. If the patient volunteers to perform repeat testing after a 30 minute wait, this will add a further 40 minutes to their session, making the visit 1 hour and 40 minutes in total.
Intervention code [1] 293660 0
Diagnosis / Prognosis
Comparator / control treatment
Participants will be invited to return for repeat testing within one week of their initial visit. During this visit participants will again rate their level of breathlessness and perform slow and forced spirometry manoeuvres. They will then be given a placebo inhaler and 15 minutes later the spirometry sequence will be repeated. The placebo inhaler will assess expectancy effect on both spirometric outcomes and the reporting of breathlessness pre- and post its administration. The placebo inhaler contains only the non-CFC propellant (GR106642X), which is the propellant used in the active medication; Ventolin (Salbutamol).
Control group
Placebo

Outcomes
Primary outcome [1] 297349 0
Proportion of participants who achieve a percentage and absolute improvement post-bronchodilator administration in one or more spirometry parameters that is greater than or equal to 200ml and 12% from baseline or percentage predicted, Spirometric parameters include: forced expiratory volume in one second (FEV1), forced vital capacity (FVC), inspiratory vital capacity (IVC), slow vital capacity (SVC), and inspiratory capacity (IC).
Timepoint [1] 297349 0
Immediately prior to bronchodilator administration and 15 minutes post bronchodilator administration.
Primary outcome [2] 298134 0
Proportion of participants who achieve a percentage improvement from baseline or predicted spirometry values that is greater than the 95% confidence limit generated from the variability of the individual's pre-bronchodilator spirometry. This improvement can be in one or more of the following spirometric parameters: forced expiratory volume in one second (FEV1), forced vital capacity (FVC), inspiratory vital capacity (IVC), slow vital capacity (SVC), or inspiratory capacity (IC).
Timepoint [2] 298134 0
Immediately prior to bronchodilator administration and 15 minutes post bronchodilator administration.
Primary outcome [3] 298135 0
Proportion of participants who achieve an absolute improvement from baseline or percentage predicted values that is greater than the 95% confidence limit generated from the collective spirometry variability of all participants. This improvement can be in one or more of the following spirometric parameters: forced expiratory volume in one second (FEV1), forced vital capacity (FVC), inspiratory vital capacity (IVC), slow vital capacity (SVC), or inspiratory capacity (IC).
Timepoint [3] 298135 0
Immediately prior to bronchodilator administration and 15 minutes post bronchodilator administration.
Secondary outcome [1] 320786 0
Percentage change in two aspects of dyspnoea (described as current level of breathlessness and wheeze, respectively). Dyspnoea is scored using a visual analogue scale (0 - 100).
Timepoint [1] 320786 0
Dyspnoea score obtained immediately prior to patient commencing initial spirometry manoevures and 15 minutes after bronchodilator or placebo administration, immediately prior to commencing post-bronchodilator or post-placebo spirometry manoevres.
Secondary outcome [2] 320787 0
Score obtained from the Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire will be correlated with primary outcome measures.
Timepoint [2] 320787 0
The Clinical COPD Questionnaire assesses respiratory symptoms experienced by the patient in the last week (7 days). It will be administered during the 15 minute wait period between spirometry testing sessions.
Secondary outcome [3] 323536 0
The spirometry parameter with the lowest variability as determined by the coefficient of repeatability calculated from paired individual measurements
Timepoint [3] 323536 0
Measurements will be made either 30 minutes apart, or on a separate day within one calendar week of the initial measurement. Spirometry parameters include: forced expiratory volume in one second (FEV1), forced vital capacity (FVC), inspiratory vital capacity (IVC), slow vital capacity (SVC), or inspiratory capacity (IC).

Eligibility
Key inclusion criteria
Aged 18 - 95 years.
Having a bronchodilator response test as part of their visit to the respiratory laboratory.
Able to provide informed consent.
Minimum age
18 Years
Maximum age
95 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patient has an absolute contraindication to performing spirometry. This includes: recent mycardial infarction, recent eye or thoracic surgery, or any other condition deemed by the testing scientist to put the patient at risk.
Patient is unable to perform acceptable spirometry.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised 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 receiving the treatment/s


Intervention assignment
Other
Other design features
This study has a partial cross-over design. A representative subset of participants will receive a placebo bronchodilator on their second visit to the laboratory for testing. This is in addition to receiving the active bronchodilator as part of their clinical care during their initial visit. They therefore act as their own control.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Approximately 800 participants will be recruited for this study. This number is based on the sample sizes of previous research conducted in this field.
With a 5% margin of error and a 99% confidence level, sampling from a large population requires at least 643 participants. Recruiting up to 800 patients will ensure that the study will remain sufficiently powered even if some results cannot be included.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/04/2016
Actual
2/05/2016
Date of last participant enrolment
Anticipated
1/05/2020
Actual
Date of last data collection
Anticipated
1/05/2020
Actual
Sample size
Target
800
Accrual to date
Final
Recruitment outside Australia
Country [1] 7605 0
New Zealand
State/province [1] 7605 0
Canterbury

Funding & Sponsors
Funding source category [1] 292929 0
Hospital
Name [1] 292929 0
Canterbury District Health Board
Country [1] 292929 0
New Zealand
Primary sponsor type
Individual
Name
Laura Ploen
Address
Respiratory Physiology Laboratory
4th Floor, Riverside Building
Christchurch Hospital
Private Bag 4710
Christchurch, 8140
New Zealand
Country
New Zealand
Secondary sponsor category [1] 291687 0
None
Name [1] 291687 0
Address [1] 291687 0
Country [1] 291687 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294435 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 294435 0
Health and Disability Ethics Committee
Ministry of Health
Freyberg Building
20 Aitken Street
PO Box 5013
Wellington, 6011
Ethics committee country [1] 294435 0
New Zealand
Date submitted for ethics approval [1] 294435 0
26/11/2015
Approval date [1] 294435 0
14/12/2015
Ethics approval number [1] 294435 0
15/NTA/207

Summary
Brief summary
This is an observational study of human participants recruited in their capacity as consumers of health or disability support services and their informed consent will be obtained.

Patients already performing a bronchodilator response test as part of their clinical care will be recruited, This test assesses the reversibility of any airway obstruction present and current international guidelines for determining what constitutes a significant response to a bronchodilator are not well informed. Patients will perform the test as per laboratory protocol with additional slow and less strenuous manoeuvres added. Patients will also rate their level of breathlessness before and after being given the inhaler (bronchodilator) and complete a questionnaire on respiratory symptoms and medications, the scores of which will be correlated with the degree of change in each pulmonary function parameter.

The testing session will be repeated on patients who volunteer to extend their appointment on the same day or return within one week of their initial visit. Those returning on another day will be given a placebo inhaler (single-blinded) to assess the placebo or expectancy effect of bronchodilator administration on spirometry and self-reported measures of breathlessness.

This study aims to quantify the natural, short-term variability of spirometry in a representative sample of respiratory patients by obtaining repeated spirometry measurements from patients attending the Respiratory Physiology Laboratory. This variability data will be used to create confidence limits for the spirometric parameters and this will determine the change that is required in these parameters to confirm reversibility of airway obstruction. This study will also determine whether alternative spirometry parameters, other than those currently recommended by international guidelines, may better detect a significant bronchodilator response in some patient subgroups.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62858 0
Miss Laura Ploen
Address 62858 0
Respiratory Physiology Laboratory
4th Floor, Riverside Building
Christchurch Hospital
Private Bag 4710
Christchurch, 8140
Country 62858 0
New Zealand
Phone 62858 0
+64 3 364 0425
Fax 62858 0
+64 3 364 0878
Email 62858 0
[email protected]
Contact person for public queries
Name 62859 0
Laura Ploen
Address 62859 0
Respiratory Physiology Laboratory
4th Floor, Riverside Building
Christchurch Hospital
Private Bag 4710
Christchurch, 8140
Country 62859 0
New Zealand
Phone 62859 0
+6433640425
Fax 62859 0
+64 3 364 0878
Email 62859 0
[email protected]
Contact person for scientific queries
Name 62860 0
Laura Ploen
Address 62860 0
Respiratory Physiology Laboratory
4th Floor, Riverside Building
Christchurch Hospital
Private Bag 4710
Christchurch, 8140
Country 62860 0
New Zealand
Phone 62860 0
+6433640425
Fax 62860 0
+64 3 364 0878
Email 62860 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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