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Trial registered on ANZCTR


Registration number
ACTRN12618000837224
Ethics application status
Approved
Date submitted
16/05/2018
Date registered
18/05/2018
Date last updated
16/01/2019
Date data sharing statement initially provided
16/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Role of home telemonitoring of lung function using the forced oscillation technique (FOT) in asthma during stable treatment.
Scientific title
Role of home telemonitoring of lung function using the forced oscillation technique in predicting exacerbations and control among moderate-severe asthmatics during stable treatment: a pragmatic, observational study
Secondary ID [1] 294871 0
CT­2017­CTN­03229­1 v1
Universal Trial Number (UTN)
U1111-1204-1827
Trial acronym
ASTHMA-HOMEMON
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 307822 0
Condition category
Condition code
Respiratory 306869 306869 0 0
Asthma

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
In a pragmatic, observational study, we will evaluate the ability of day-to-day variations in lung function measured by the forced oscillation technique (FOT), to predict occurrence of exacerbations (primary outcome) and changes in symptom control (secondary outcome) in asthma, during a period of stable treatment unless otherwise clinically-indicated by their physician.

Potential patients are identified during routine clinic visits (treated as Visit 1) or recruited from the community based on their clinical status, i.e. poorly-controlled symptoms despite being on maximal ICS treatment dose, and not being considered at the point of screening for down- or up-titration of their treatment by their treating physician within the next 6 months. Patients who are eligible for the study will be asked if they are willing to participate in home monitoring, and have their baseline health status, symptoms (ACQ-5) and standard respiratory function (spirometry and lung volumes) data collected as part of their standard clinical assessment.

Patients willing to participate in the study will have a FOT device installed in their homes by a study investigator (a respiratory researcher familiar with FOT), who will train them to make unsupervised FOT self-measurements during a 30-45 minute visit.

Participants will be monitored for an initial (approximate) 8-week baseline period during which existing treatment will be unchanged unless clinically warranted. At approximately the 8-week (Visit 2) and/or 16-week (Visit 3) marks, their clinical status will be evaluated, either via their last clinic visits or an appointment, to assess whether treatment changes are warranted.

Monitoring will cover a total period of approximately 24 weeks (8 weeks of baseline period + 16 weeks prediction phase). During this time, any treatment decisions/changes will be made solely by the treating physician based on the patient’s clinical need.

Throughout the entire study period, patients will self-record symptoms and FOT once daily in the morning, followed by a PEF measurement, before taking their maintenance treatment. Patients will also have weekly telephone interviews where questionnaire data (ACQ), symptoms and exacerbations will be captured. Details of measurements performed during home monitoring can be found below.

Treatment Changes
Should a treating physician deem that a change in treatment is warranted during any phase, e.g. due to loss of control or exacerbations, patients will not need to be withdrawn, but will continue daily monitoring as per usual.

FOT Measurements
FOT home monitoring devices (Resmon Pro DIARY, Restech srl, Milan, Italy) will be set up at the patient’s home at enrolment. The technical specifications for the device have been previously published [Dellaca et al, Physiol Meas (2010) 31:N11–N24]. During measurement, a loudspeaker generates 5-11-19 Hz forced oscillations delivered to the airway opening via an antibacterial filter/mouthpiece assembly. The resulting airway opening pressure and flow are measured and used to calculate respiratory resistance. These can be further partitioned into an inspiratory and expiratory component.

Patients will be instructed to make a 1- to 2-min measurement (for a minimum of 10 technically acceptable breaths) each day during normal breathing whilst seated, wearing a nose clip and with cheeks supported. De-identified FOT data will be uploaded daily via the 4G mobile internet network to encrypted servers, where they will be checked for quality by a research assistant.

PEF Measurements
Following FOT, patients will also monitor their PEF using a digital spirometer using standardised protocol, i.e. highest of 3 blows. Patients who currently make PEF measurements will be asked to use the digital spirometer, and they will be shown how to extract the results for their normal monitoring. Patients who have never made PEF measurements before will be instructed on how to do them during the home visit.

Symptom and Exacerbation Measurements
Daily symptoms will be entered into an electronic diary prior to the FOT measurement via the same device interface. We will use an adaptation of symptom diary used in a recently published trial [Virchow et al, Jama (2016) 315:1715-25], from which the definition of moderate exacerbations was derived. In addition, study personnel will contact the patient weekly to record treatment changes, symptoms (ACQ-5), medications and asthma-related healthcare utilisation, to capture changes in asthma control and/or exacerbations. During this time, patients will continue to see their usual healthcare provider when necessary.
Intervention code [1] 301184 0
Early Detection / Screening
Intervention code [2] 301185 0
Diagnosis / Prognosis
Comparator / control treatment
The patients' own periods of no exacerbations and/or baseline periods serve as their own controls.
Control group
Active

Outcomes
Primary outcome [1] 305859 0
Occurrence of moderate asthma exacerbations.

These will be defined based on ATS/ERS criteria, as operationalised by Virchow et al [Respir Med (2015) 109:547-556], i.e. based on at least one of the following factors:
• Nocturnal awakening(s) due to asthma requiring SABA for 2 consecutive nights or increase of greater than or equal to 0.75 from baseline in daily symptom score on 2 consecutive days (obtained from symptom diary on FOT device)
• Increase from baseline in occasions of SABA use on 2 consecutive days of greater than or equal to 4 puffs/day (obtained from symptom diary on FOT device)
• Greater than or equal to 20% decrease in PEF from baseline on at least 2 consecutive mornings/evenings (downloaded from PEF device)
• Visit to the emergency department for asthma treatment not requiring systemic corticosteroids (obtained from weekly phone calls)

Timepoint [1] 305859 0
All moderate asthma exacerbations (assessed weekly from daily data) that have occurred at the end of the 24-week study period.
Primary outcome [2] 305860 0
Occurrence of severe asthma exacerbations.

These will be recorded, based on the ATS/ERS criteria of events requiring treatment with systemic corticosteroids for greater than or equal to 3 days, and/or hospitalisation or emergency department visit requiring corticosteroid treatment [Reddel et al, Am J Respir Crit Care Med (2009) 180:59–99]. These data will be obtained from weekly phone calls.
Timepoint [2] 305860 0
All severe asthma exacerbations (assessed weekly from daily data) that have occurred at the end of the 24-week study period.
Secondary outcome [1] 346817 0
Change in Asthma Control Questionnaire score, which measures degree of improvement/deterioration in the patient's asthma control status
Timepoint [1] 346817 0
In weekly intervals over the 24-week trial period
Secondary outcome [2] 346818 0
Change in the variability of inspiratory FOT resistance (R5,insp), obtained from daily measurements recorded by the FOT home monitoring device
Timepoint [2] 346818 0
Variability is assessed from daily data in weekly intervals over the 24-week trial period. Change in the variability is calculated from the week before and week after any prescribed changes in asthma treatment.
Secondary outcome [3] 346819 0
Change in the variability of inspiratory FOT reactance (X5,insp), obtained from daily measurements recorded by the FOT home monitoring device
Timepoint [3] 346819 0
Variability is assessed from daily data in weekly intervals over the 24-week trial period. Change in the variability is calculated from the week before and week after any prescribed changes in asthma treatment.
Secondary outcome [4] 346820 0
Change in the variability of PEF, obtained from daily measurements recorded by the home spirometer device.
Timepoint [4] 346820 0
Variability is assessed from daily data in weekly intervals over the 24-week trial period. Change in the variability is calculated from the week before and week after any prescribed changes in asthma treatment.

Eligibility
Key inclusion criteria
Inclusion Criteria:
• above 18 years of age,
• diagnosis of asthma, confirmed by written report from a physician, and
• receiving maintenance asthma treatment at at least Step 4 (on moderate to high dose of ICS (budesonide >500 mcg/day or fluticasone propionate >200 mcg/day or equivalent and LABA treatment) of Australian guidelines, and
• ACQ-5 score >=1.5, indicating suboptimal asthma symptom control.

All patients will be eligible if they are taking maximal inhaled therapy (high dose ICS/LABA with or without other add-on therapy) and have at least one of the following additional risk factors for poor asthma outcomes or exacerbation's, i.e.: at least one severe exacerbation in the past 12 months, low FEV1 (<60% predicted), obesity (BMI >=30), and in addition, the treating physician considers that there is no immediate indication for stepping up treatment. For example, this decision may be made by the treating physician if the risks of further stepping up treatment outweigh the potential benefit, if alternative non-biologic therapies have already been tried, or if the patient does not satisfy PBS criteria for a biological therapy.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• any other confounding major disease or condition as deemed appropriate by investigator, determined by review of medical history and/or patient reported medical history, and
• impaired ability to understand instructions or perform FOT unsupervised.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
FOT data from the first 8 weeks (baseline phase) will be used to calculate the typical risk profile for each individual patient using the variability and statistical properties of FOT data. Following this, data from the subsequent 16 weeks (prediction phase) will be used in a day-by-day rolling update of the patient’s risk profile and to test predictive value for symptom control changes and occurrence of clinically-defined exacerbation's.

Recruitment
Recruitment status
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
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 10882 0
Concord Repatriation Hospital - Concord
Recruitment hospital [2] 10883 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [3] 10884 0
Woolcock Institute of Medical Research - Glebe
Recruitment postcode(s) [1] 22640 0
2139 - Concord
Recruitment postcode(s) [2] 22641 0
2065 - St Leonards
Recruitment postcode(s) [3] 22642 0
2037 - Glebe
Recruitment postcode(s) [4] 22643 0
2139 - Concord Repatriation Hospital
Recruitment postcode(s) [5] 22644 0
2065 - Royal North Shore Hospital
Recruitment postcode(s) [6] 22645 0
2037 - Forest Lodge

Funding & Sponsors
Funding source category [1] 299458 0
Other Collaborative groups
Name [1] 299458 0
Centre of Excellence in Severe Asthma
Address [1] 299458 0
CRE in Severe Asthma
Hunter Medical Research Institute,
1 Kookaburra Circuit,
New Lambton Heights NSW 2305.
Country [1] 299458 0
Australia
Primary sponsor type
University
Name
Sydney Medical School, University of Sydney
Address
University of Sydney, Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 298756 0
Other
Name [1] 298756 0
Woolcock Institute of Medical Research
Address [1] 298756 0
431 Glebe Point Road, Glebe NSW 2037
Country [1] 298756 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300364 0
Sydney Local Health District HREC - CRGH
Ethics committee address [1] 300364 0
Concord Repatriation General Hospital
Concord NSW 2139
Ethics committee country [1] 300364 0
Australia
Date submitted for ethics approval [1] 300364 0
27/06/2017
Approval date [1] 300364 0
04/09/2017
Ethics approval number [1] 300364 0
CH62/6/2017-119

Summary
Brief summary
Clinical management of asthma involves tailoring medication to minimise the frequency and intensity of symptoms and prevent exacerbation's. However, management is currently based on subjective patient recall of symptoms, rather than objective and personalised measures of current status and predictors of future risk of exacerbation's. A potential solution may be offered by daily home monitoring using Forced Oscillation Technique (FOT), which patients can measure unsupervised at home due to its ease of use compared to peak flow or spirometry. We have shown potential clinical utility of advanced analyses to study the day­-to-­day variability in lung function in asthma in a series of retrospective studies, including the ability to predict future exacerbation's within a month in an individual. This project aims to adapt such analyses to FOT data as the basis of a home telemonitoring system, and initiate a prospective study investigating the potential benefit of long-­term FOT home monitoring in Australian patients with both well­-controlled and uncontrolled asthma.

We aim to show that FOT variability (i) predicts occurrence of exacerbation's, (ii) is related to asthma control, and (iii) is sensitive to treatment changes.

We will demonstrate this by studying moderate-to-severe asthma patients in a pragmatic, observational study in well­-controlled asthma patients who are being considered for reduction of their inhaled corticosteroid treatment dose. Treatment is initiated by the physician according to Australian guidelines independent of participation in the study, and we will study these relationships regardless of the nature of treatment.

We will monitor unsupervised FOT measurements and symptoms over a period of 10-­24 weeks. Data will be uploaded automatically via mobile internet to encrypted servers and regularly checked for quality. We will also monitor exacerbation's and asthma control via weekly telephone interviews and questionnaires.

From these results, we eventually hope to develop an automated alert system which can signal to the patient whether or not they are about to deteriorate and to initiate self-treatment, enabling them to gain control of their disease.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 83414 0
Dr Cindy Thamrin
Address 83414 0
Woolcock Institute of Medical Research
431 Glebe Point Road
Glebe, NSW, 2037, Sydney,
Country 83414 0
Australia
Phone 83414 0
+61 2 9114 0440
Fax 83414 0
Email 83414 0
cindy.thamrin@woolcock.org.au
Contact person for public queries
Name 83415 0
Ms Lucy Williams
Address 83415 0
Woolcock Institute of Medical Research
431 Glebe Point Road
Glebe, NSW, 2037, Sydney,
Country 83415 0
Australia
Phone 83415 0
+61 403 753 028
Fax 83415 0
Email 83415 0
l.williams@sydney.edu.au
Contact person for scientific queries
Name 83416 0
Dr Cindy Thamrin
Address 83416 0
Woolcock Institute of Medical Research
431 Glebe Point Road
Glebe, NSW, 2037, Sydney,
Country 83416 0
Australia
Phone 83416 0
+61 2 9114 0440
Fax 83416 0
Email 83416 0
cindy.thamrin@woolcock.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Daily lung function and electronic diary symptom data, de-identified.
When will data be available (start and end dates)?
Following publication of the study, for 15 years from completion of study as per Good Clinical Practice.
Available to whom?
To researchers, upon request in writing, stating purpose and type of analyses, if deemed to be non-commercial in nature.
Available for what types of analyses?
For scientific (non-commercial) research purposes, including but not limited to posthoc research questions, meta analyses.
How or where can data be obtained?
File transfer from a secure password-protected server.
What supporting documents are/will be available?
No other documents available
Summary results
No Results