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Trial registered on ANZCTR


Registration number
ACTRN12620001010987
Ethics application status
Approved
Date submitted
3/08/2020
Date registered
7/10/2020
Date last updated
7/10/2020
Date data sharing statement initially provided
7/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A proof-of-concept single group study of an anti-inflammatory reliever therapy stepwise approach to the pharmacological treatment of adult asthma.
Scientific title
A proof-of-concept single group study to assess patient satisfaction with an anti-inflammatory reliever therapy stepwise approach to the pharmacological treatment of adult asthma.
Secondary ID [1] 301829 0
MRINZ/19/13
Universal Trial Number (UTN)
U1111-1246-5446
Trial acronym
AIR Algorithm Study
Linked study record
MRINZ/19/13: AT (sub-study) - ACTRN12620001006932p
MRINZ/19/13: AQ (sub-study)

Health condition
Health condition(s) or problem(s) studied:
Asthma 318308 0
Condition category
Condition code
Respiratory 316319 316319 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The AIR Algorithm Study is a prospective, single-centre, open label, single group study aimed at assessing the utility of the Anti-Inflammatory Reliever (AIR) therapy stepwise approach to the pharmacological treatment of adult asthma (AIR Algorithm).

100 participants will be assigned to the AIR Algorithm for 52 weeks.

The AIR Algorithm uses a single combined budesonide-formoterol (Symbicort Turbuhaler 200/6 micrograms) dry powder inhaler and a stepwise change in treatment according to asthma symptoms.

The AIR Algorithm treatment steps are:
1) Step 1 - one actuation as required (PRN) for the relief of symptoms with no regular maintenance therapy.
2) Step 2 - one actuation PRN and one actuation twice daily as regular maintenance therapy.
3) Step 3 - one actuation PRN and two actuations twice daily as regular maintenance therapy.

At enrolment, participants will be allocated an AIR Algorithm treatment step according to their pre-enrolment asthma therapy based on the Global Initiative for Asthma (GINA) 2018 criteria:
1) AIR Algorithm Step 1 - pre-enrolment GINA Step 1 therapy (Short-Acting Beta-Agonist [SABA] monotherapy).
2) AIR Algorithm Step 2 - pre-enrolment GINA Step 2 and 3 therapy (Inhaled Corticosteroid [ICS] plus SABA reliever or low dose ICS/Long-Acting Beta-Agonist [LABA] plus SABA reliever).
3) AIR Algorithm Step 3 - pre-enrolment GINA Step 4 therapy (medium or high dose ICS/LABA plus SABA reliever).

Treatment steps will be adjusted throughout the trial in accordance with a participant’s reported inhaler use and whether they have experienced an asthma attack. All treatment step changes will be based on participant self-report. All study inhalers will also be fitted with Turbu+ electronic monitors that record patterns of inhaler use.
Participants will:
1) ‘Step down’ if they report using two or fewer actuations per week for symptom relief. Step 1 represents the lowest level of treatment.
2) Remain on the same treatment step if they report using greater than two, but seven or fewer actuations per week for symptom relief.
3) ‘Step up’ if they report using greater than seven actuations per week for symptom relief or if they have an asthma attack. For the purposes of this study an asthma attack is defined as a deterioration in asthma symptoms severe enough to warrant the use or prescription of systemic corticosteroids, such as a course of prednisone. If a participant on Step 3 meets the requirements for stepping up, they will remain on the same treatment and be referred to a specialist respiratory clinic on study completion.

The study will be conducted in two phases:
1) Phase One will cover the first 26 weeks with treatment steps reviewed and adjusted by study staff at study visits every 13 weeks.
2) Phase Two will cover week 26 to week 52 when participants will be encouraged to adjust their own treatment step. At 26 weeks, during a study visit, study staff will provide participants with a written asthma management plan detailing the AIR algorithm and explain to participants how and when to review and adjust their own treatment step. From week 26 to week 39 participants will be asked to review their treatment monthly. Between week 39 and week 52 participants will be encouraged to adjust their treatment as often as they feel necessary.

In order to assist participant self-report over the 52-week duration of the study, Asthma Diary Cards and a MyCap mobile app alternative have been developed specifically for this study. Participants will be encouraged to record details of:
1) Urgent medical reviews due to asthma.
2) Courses of systemic corticosteroids for asthma.
3) Changes to any medications.
4) Self-adjusted treatment step changes.

Two additional sub-studies are planned alongside the AIR Algorithm study:
1) The AIR Tutorial sub-study (AIR-T) - an embedded randomised controlled sub-study designed assess whether interactive comic tutorials can help adult patients with asthma understand and adhere to an anti-inflammatory reliever therapy regimen. All 100 participants enrolled in the AIR Algorithm parent study will undergo randomisation, with 50 participants allocated to receive the interactive comic tutorials. These materials have been designed specifically for this study and will cover the rationale of the AIR Algorithm concept, when to seek medical help and how to self-manage care using the AIR Algorithm.
2) The AIR Qualitative sub-study (AIR-Q) - a qualitative sub-study to enhance understanding of the findings of the main study, and to explore patient attitudes to the treatment regimen. A subset of participants will be invited for an optional interview at the end of the trial. Recruitment will be purposive, based on a sampling framework that includes high and low levels or reported treatment satisfaction, specific AIR Algorithm treatment steps, withdrawal status, age group and gender, in order to enrol a broad distribution of participants. The interviewer will use the existing study data to select participants to be approached for interview, according to the sampling framework, timing of study visits, and the participants already interviewed.
Intervention code [1] 318134 0
Treatment: Drugs
Intervention code [2] 318503 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324501 0
Participant satisfaction with the AIR stepwise approach to the pharmacological treatment of adult asthma assessed by Treatment Satisfaction Questionnaire for Medicines (TSQM v.II) Overall Satisfaction score (Phase One).
Timepoint [1] 324501 0
At 26 weeks after intervention commencement.
Primary outcome [2] 324502 0
Participant satisfaction with the AIR stepwise approach to the pharmacological treatment of adult asthma assessed by TSQM v.II Overall Satisfaction score (Phase Two).
Timepoint [2] 324502 0
At 52 weeks after intervention commencement.
Secondary outcome [1] 384816 0
Participant satisfaction with the AIR stepwise approach to the pharmacological treatment of adult asthma assessed by individual scores for each domain of the TSQM v.II (Effectiveness, Convenience, Side Effects and Overall Satisfaction).
Timepoint [1] 384816 0
Baseline, 13 weeks, 26 weeks, 39 weeks, and 52 weeks after intervention commencement.
Secondary outcome [2] 384817 0
Participant satisfaction with the AIR stepwise approach to the pharmacological treatment of adult asthma assessed by Participant Management Preference Question results (a question designed specifically for the study, scored on a 5-point Likert Scale).
Timepoint [2] 384817 0
At 26 weeks and 52 weeks after intervention commencement.
Secondary outcome [3] 384818 0
Participant beliefs about medicines used in the AIR stepwise approach to the pharmacological treatment of adult asthma assessed by Beliefs about Medicines Questionnaire - Anti-Inflammatory Reliever (BMQ-AIR) scores.
Timepoint [3] 384818 0
Baseline, 26 weeks, and 52 weeks after intervention commencement.
Secondary outcome [4] 384819 0
Participant beliefs about medicines used in the AIR stepwise approach to the pharmacological treatment of adult asthma assessed by Beliefs about Medicines Questionnaire - Short-Acting Beta-Agonist (BMQ-SABA) scores.
Timepoint [4] 384819 0
Baseline, 26 weeks, and 52 weeks after intervention commencement.
Secondary outcome [5] 384820 0
Participant flow through the AIR stepwise approach to the pharmacological treatment of asthma by assessing the proportion of participants on each treatment step (treatment steps 1-3).
Timepoint [5] 384820 0
Baseline, 13 weeks, 26 weeks, 39 weeks, and 52 weeks after intervention commencement.
Secondary outcome [6] 384821 0
Participant flow through the AIR stepwise approach to the pharmacological treatment of asthma by assessing the proportion of participants that change treatment step (determined by review of study records, participant self-report at study visits, and participant diaries).
Timepoint [6] 384821 0
At 13 weeks, 26 weeks, 39 weeks, and 52 weeks after intervention commencement.
Secondary outcome [7] 385049 0
Participant flow through the AIR stepwise approach to the pharmacological treatment of asthma by assessing the self-reported number of times participants changed treatment step (determined via participant self-report at study visits and participant diaries).
Timepoint [7] 385049 0
At 13 weeks and 26 weeks after initiation of participant led treatment step changes (which correspond to 39 weeks, 52 weeks and 26 weeks after intervention commencement, respectively).
Secondary outcome [8] 385050 0
Participant flow through the AIR stepwise approach to the pharmacological treatment of asthma by assessing inhaler use (determined by Turbu+ electronic monitors fitted to study inhalers) in the 4 weeks prior to participant led treatment step change.
Timepoint [8] 385050 0
At 13 weeks after initiation of monthly participant led treatment step changes (which correspond to 39 weeks and 26 weeks after intervention commencement respectively).
Secondary outcome [9] 385051 0
Participant flow through the AIR stepwise approach to the pharmacological treatment of asthma by assessing inhaler use (determined by Turbu+ electronic monitors fitted to study inhalers) in the 7 days prior to participant led treatment step change.
Timepoint [9] 385051 0
At 13 weeks after initiation of as-needed participant led treatment step changes (which correspond to 52 weeks and 39 weeks after intervention commencement respectively).
Secondary outcome [10] 385052 0
The effectiveness of the AIR stepwise approach to the pharmacological treatment of adult asthma by assessing Asthma Control Test (ACT) scores.
Timepoint [10] 385052 0
Baseline, 26 weeks, and 52 weeks after intervention commencement.
Secondary outcome [11] 385053 0
The effectiveness of the AIR stepwise approach to the pharmacological treatment of adult asthma by assessing Asthma Control Questionnaire (ACQ-5) scores.
Timepoint [11] 385053 0
Baseline, 26 weeks, and 52 weeks after intervention commencement.
Secondary outcome [12] 385054 0
The effectiveness of the AIR stepwise approach to the pharmacological treatment of adult asthma by assessing Asthma Quality of Life with Standardised activities Questionnaire (AQLQ-S) scores.
Timepoint [12] 385054 0
Baseline, 26 weeks, and 52 weeks after intervention commencement.
Secondary outcome [13] 385055 0
The effectiveness of the AIR stepwise approach to the pharmacological treatment of adult asthma by assessing on-treatment Forced Expiratory Volume over 1 second (FEV1) results using using Easy-on PC spirometry testing.
Timepoint [13] 385055 0
Baseline, 26 weeks, and 52 weeks after intervention commencement.
Secondary outcome [14] 385056 0
The effectiveness of the AIR stepwise approach to the pharmacological treatment of adult asthma by assessing Fractional exhaled Nitric Oxide (FeNO) levels using NOBreath FeNO breath monitoring.
Timepoint [14] 385056 0
Baseline, 26 weeks, and 52 weeks after intervention commencement.
Secondary outcome [15] 385057 0
The effectiveness of the AIR stepwise approach to the pharmacological treatment of adult asthma by assessing the rate of severe asthma exacerbations (determined via participant self-report at the time of the event, participant diaries and medical records).
For the purposes of this study a severe asthma exacerbation is defined as:
1) the use of systemic corticosteroids for at least 3 days because of asthma,
2) hospitalisation or emergency department (ED) visit because of asthma, requiring systemic corticosteroids, or
3) worsening asthma resulting in unplanned medical review (primary care or ED visit) severe enough to warrant an acute prescription of systemic corticosteroid, such as a course of prednisone.
Timepoint [15] 385057 0
At 26 weeks and 52 weeks after intervention commencement.
Secondary outcome [16] 385058 0
The effectiveness of the AIR stepwise approach to the pharmacological treatment of adult asthma by assessing the rate of severe and moderate asthma exacerbations (determined via participant self-report at the time of the event, participant diaries and medical records).
For the purposes of this study a severe asthma exacerbation is defined as:
1) the use of systemic corticosteroids for at least 3 days because of asthma,
2) hospitalisation or emergency department (ED) visit because of asthma, requiring systemic corticosteroids, or
3) worsening asthma resulting in unplanned medical review (primary care or ED visit) severe enough to warrant an acute prescription of systemic corticosteroid, such as a course of prednisone.
For the purposes of this study a moderate asthma exacerbation is defined as:
1) worsening asthma resulting in unplanned medical review (primary care or ED visit) but not severe enough to warrant systemic corticosteroid use, such as a course of oral prednisone, and/or hospital admission, or
2) worsening asthma resulting in the use of systemic corticosteroids for fewer than 3 days.
Timepoint [16] 385058 0
At 26 weeks and 52 weeks after intervention commencement.
Secondary outcome [17] 385059 0
The effectiveness of the AIR stepwise approach to the pharmacological treatment of adult asthma by assessing the time to first severe asthma exacerbation.
Timepoint [17] 385059 0
Assessed up to 52 weeks from intervention commencement.
Secondary outcome [18] 385060 0
The effectiveness of the AIR stepwise approach to the pharmacological treatment of adult asthma by assessing the proportion of participants withdrawn from the study and reason for withdrawal according to study records.
Timepoint [18] 385060 0
At 26 weeks and 52 weeks after intervention commencement.
Secondary outcome [19] 385061 0
Patterns of medication use with the AIR stepwise approach to the pharmacological treatment of adult asthma by assessing the difference between participant reported inhaler use (determined via participant self-report at study visits) and electronic monitor recorded use (determined by Turbu+ electronic monitors fitted to study inhalers).
Timepoint [19] 385061 0
At 13 weeks, 26 weeks, 39 weeks and 52 weeks after intervention commencement.
Secondary outcome [20] 385062 0
Patterns of medication use with the AIR stepwise approach to the pharmacological treatment of adult asthma by assessing the mean inhaled corticosteroid (ICS) dose per day (budesonide micrograms/day, determined by Turbu+ electronic monitors fitted to study inhalers).
Timepoint [20] 385062 0
At 13 weeks, 26 weeks, 39 weeks and 52 weeks after intervention commencement.
Secondary outcome [21] 385063 0
Patterns of medication use with the AIR stepwise approach to the pharmacological treatment of adult asthma by assessing all other asthma related medications taken (determined via participant self-report at study visits, participant diaries and medical records).
Timepoint [21] 385063 0
At 13 weeks, 26 weeks, 39 weeks and 52 weeks after intervention commencement.
Secondary outcome [22] 385064 0
Patterns of medication use with the AIR stepwise approach to the pharmacological treatment of adult asthma by assessing the longest duration of no actuations in days (determined by Turbu+ electronic monitors fitted to study inhalers).
Timepoint [22] 385064 0
At 13 weeks, 26 weeks, 39 weeks and 52 weeks after intervention commencement.
Secondary outcome [23] 385065 0
Patterns of medication use with the AIR stepwise approach to the pharmacological treatment of adult asthma by assessing the proportion of days of no inhaler use (determined by Turbu+ electronic monitors fitted to study inhalers).
Timepoint [23] 385065 0
At 13 weeks, 26 weeks, 39 weeks and 52 weeks after intervention commencement.
Secondary outcome [24] 385066 0
Patterns of medication use with the AIR stepwise approach to the pharmacological treatment of adult asthma by assessing the number of days of high inhaler use (greater than 8 actuations of budesonide-formoterol 200/6 micrograms in a 24-hour period, determined by Turbu+ electronic monitors fitted to study inhalers).
Timepoint [24] 385066 0
At 13 weeks, 26 weeks, 39 weeks and 52 weeks after intervention commencement.
Secondary outcome [25] 385067 0
Patterns of medication use with the AIR stepwise approach to the pharmacological treatment of adult asthma by assessing the proportion of high inhaler use episodes (greater than 8 actuations of budesonide-formoterol 200/6 micrograms in a 24-hour period, determined by Turbu+ electronic monitors fitted to study inhalers) without medical review within 48 hours (determined via participant self-report at study visits, participant diaries and medical records).
Timepoint [25] 385067 0
At 13 weeks, 26 weeks, 39 weeks and 52 weeks after intervention commencement.
Secondary outcome [26] 385068 0
Patterns of medication use with the AIR stepwise approach to the pharmacological treatment of adult asthma by assessing the number of days of marked inhaler overuse (greater than 12 actuations of budesonide-formoterol 200/6 micrograms in a 24-hour period, determined by Turbu+ electronic monitors fitted to study inhalers).
Timepoint [26] 385068 0
At 13 weeks, 26 weeks, 39 weeks and 52 weeks after intervention commencement.
Secondary outcome [27] 385069 0
Patterns of medication use with the AIR stepwise approach to the pharmacological treatment of adult asthma by assessing the proportion of marked inhaler overuse episodes (greater than 12 actuations of budesonide-formoterol 200/6 micrograms in a 24-hour period, determined by Turbu+ electronic monitors fitted to study inhalers) without medical review within 48 hours (determined via participant self-report at study visits, participant diaries and medical records).
Timepoint [27] 385069 0
At 13 weeks, 26 weeks, 39 weeks and 52 weeks after intervention commencement.
Secondary outcome [28] 385070 0
Safety of the AIR stepwise approach to the pharmacological treatment of adult asthma by assessing the proportion of participants experiencing an adverse event such as a fungal infection in the mouth and throat, headache, or rapid or irregular heartbeat (determined by participant self-report and/or medical records utilising Common Terminology Criteria for Adverse Events [CTCAE]).
Timepoint [28] 385070 0
At 26 weeks and 52 weeks after intervention commencement
Secondary outcome [29] 385071 0
Safety of the AIR stepwise approach to the pharmacological treatment of adult asthma by assessing the proportion of participants experiencing a serious adverse event such as a severe allergic reaction, or severe spasm in the airways (determined by participant self-report and/or medical records utilising Common Terminology Criteria for Adverse Events [CTCAE]).
Timepoint [29] 385071 0
At 26 weeks and 52 weeks after intervention commencement.
Secondary outcome [30] 385074 0
Feasibility of the AIR Algorithm study design by assessing the proportion of participants that installed and used MyCap mobile app or study Asthma Diary Cards (determined by participant-self report at study visits, diary card returns and app analytics).
Timepoint [30] 385074 0
At 26 weeks and 52 weeks after intervention commencement.
Secondary outcome [31] 385075 0
Feasibility of the AIR Algorithm study design by assessing the agreement between participant reported and electronic health records of moderate and severe exacerbations.
Timepoint [31] 385075 0
At 26 weeks and 52 weeks after intervention commencement.
Secondary outcome [32] 385076 0
Feasibility of the AIR Algorithm study design by assessing the study recruitment rates.
Timepoint [32] 385076 0
At 52 weeks after intervention commencement.

Eligibility
Key inclusion criteria
1) Self-reported doctor’s diagnosis of asthma.
2) Age 18 to 75 years.
3) Current use (within the last 12 months) of either:
a) Short-acting Beta-agonist (SABA) reliever monotherapy.
b) ICS maintenance plus SABA reliever therapy.
c) ICS-Long-acting Beta-agonist (LABA) maintenance plus SABA reliever therapy.
4) Participant is willing and able to give informed consent for participation in the trial.
5) In the Investigator’s opinion, participant is able and willing to comply with all trial requirements.
6) Participant is willing to allow their General Practitioner and/or consultant, if appropriate, to be notified of participation in the trial.
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Current use (within last 3 months) of other asthma medications including:
a) Budesonide-Formoterol Single Maintenance and Reliever Therapy (SMART).
b) Leukotriene receptor antagonists.
c) Long acting muscarinic antagonists.
d) Theophylline.
e) Regular oral corticosteroids.
f) Sodium cromoglycate or nedocromil sodium.
g) Monoclonal antibody therapy.
2) Self-reported urgent medical review for asthma, or treatment with systemic corticosteroids such as oral prednisone, in the two weeks before potential study entry.
3) Intensive Care Unit (ICU) admission for asthma (ever).
4) Self-reported diagnosis of Chronic Obstructive Pulmonary disease (COPD), bronchiectasis, vocal cord dysfunction or interstitial lung disease.
5) Self-reported greater than 20 pack year smoking history, or onset of respiratory symptoms after the age of 40 years in current or ex-smokers with greater than or equal to a 10 pack year history.
6) Self-reported current pregnancy or breast feeding at the time of enrolment or planned pregnancy within the study period.
7) Self-reported congestive heart failure, atrial fibrillation, unstable coronary artery disease, or other clinically significant cardiac disease.
8) Participant is unwilling or unable to switch from current asthma treatment regimen.
9) Self-report of participation in another research trial involving an investigational product in the past 3 months.
10) A Body Mass Index (BMI) of greater than 40.
11) Any known or suspected contraindications to the medications prescribed for the study or their respective excipients.
12) Any other condition which, at the Investigator’s discretion, is believed may present a safety risk or impact the feasibility of the study or the study results.

Study design
Purpose of the study
Treatment
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
In total, the study will recruit 100 participants. One third of all participants (range 32 to 34) will be recruited from each of the three AIR Algorithm treatment steps. This sample size is chosen to give reasonable precision for estimation of standard deviations within each block.

The statistical analysis will be by intention to treat. There will be no formal adjustment for multiplicity and secondary outcome analyses will be treated as exploratory. All outcomes will be explored by treatment step at entry (Global Initiative for Asthma [GINA] 2018 criteria Step 1 to 4) and trial treatment step (AIR Algorithm Step 1 to 3).

This trial is intended to characterise patient satisfaction with the AIR Algorithm through use of the Treatment Satisfaction Questionnaire for Medication (TSQM) v.II Overall Satisfaction Score. TSQM v.II Overall Satisfaction Scores after 26 and 52 Weeks will be described with mean, standard deviation, median and inter-quartile range, and minimum to maximum. The 95% confidence for the mean at each measurement time, change from baseline, and for standard deviations, will all be reported.

The trial will also estimate the minimal clinically important difference (MCID) for each domain of the TSQM v.II in relation to the Asthma Control Test (ACT), Asthma Control Questionnaire (ACQ-5), Asthma Quality of Life with Standardised activities Questionnaire (AQLQ-S) and Forced Expiratory Volume over 1 second (FEV1). The predicted mean change in TSQM from baseline in relation to each of these variables will use the MCID values for each of these variables to estimate the equivalent change. Primary analysis for estimating the MCID of individual TSQM domains will use a regression approach to domain scores against ACT scores. Secondary analysis for estimating the MCID of individual TSQM domains will take a similar approach for ACQ-5, AQLQ-S and FEV1.

Recruitment
Recruitment status
Not yet 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 outside Australia
Country [1] 22799 0
New Zealand
State/province [1] 22799 0
Wellington

Funding & Sponsors
Funding source category [1] 306256 0
Charities/Societies/Foundations
Name [1] 306256 0
Medical Research Institute of New Zealand
Address [1] 306256 0
Medical Research Institute of New Zealand
Level 7, CSB Building
Wellington Hospital
Riddiford St, Newtown
Wellington 6021
Country [1] 306256 0
New Zealand
Funding source category [2] 306325 0
Commercial sector/Industry
Name [2] 306325 0
AstraZeneca Ltd
Address [2] 306325 0
Level 5, 15 Hopetoun St,
Freemans Bay,
Auckland 1011
Country [2] 306325 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Medical Research Institute of New Zealand
Address
Medical Research Institute of New Zealand
Level 7, CSB Building
Wellington Hospital
Riddiford St, Newtown
Wellington 6021
Country
New Zealand
Secondary sponsor category [1] 307216 0
None
Name [1] 307216 0
Address [1] 307216 0
Country [1] 307216 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306464 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 306464 0
Ministry of Health
Health and Disability Ethics Committees
133 Molesworth Street
Thorndon
Wellington 6011
Ethics committee country [1] 306464 0
New Zealand
Date submitted for ethics approval [1] 306464 0
09/07/2020
Approval date [1] 306464 0
20/08/2020
Ethics approval number [1] 306464 0
20/CEN/154

Summary
Brief summary
This is a single-arm study investigating a novel Anti-Inflammatory Reliever (AIR) Algorithm for the treatment of adult asthma. The AIR Algorithm, currently in the Asthma and Respiratory Foundation NZ guidelines, utilises a combination inhaler containing inhaled corticosteroid (ICS) and formoterol, a long-acting beta-agonist (LABA) known as a Symbicort Turbuhaler.

100 participants will be enrolled for 52-weeks with 5 scheduled visits at 3 monthly intervals. The Initial Visit involves reviewing eligibility for inclusion, collecting medical history, assessing baseline lung function (breathing tests) and obtaining informed consent. Eligible participants will complete questionnaires about their asthma symptoms and views on their treatment. New inhalers fitted with electronic monitors that record inhaler use will be issued. Participants will be given management plans specific to their treatment “step” and action plans illustrating when and how to seek medical help. Inhaler technique will be assessed and smoking cessation advice provided. Subsequent visits will involve repeating the above tests and questionnaires, and reviewing any exacerbations or adverse events.

For the first 26 weeks Study Staff will determine treatment steps depending on inhaler use and exacerbation history. From week 26 to 52, participants will be encouraged to self-adjust their treatment in accordance with the AIR Algorithm.

The main outcome of the study is participant treatment satisfaction, assessed with written questionnaires and the main question being tested is “are participants satisfied with this novel regimen?”.

A randomised sub-study will assess interactive education material on asthma management provided to half the participants in addition to the standard study staff led explanation.

A subset of participants will be invited for an optional Interview at the end of the trial to further explore attitudes towards the use of the AIR Algorithm, as part of a second separate sub-study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103978 0
Dr Pepa Bruce
Address 103978 0
Medical Research Institute of New Zealand
Level 7, CSB Building
Wellington Hospital
Riddiford St, Newtown
Wellington 6021
Country 103978 0
New Zealand
Phone 103978 0
+64 4 805 0246
Fax 103978 0
Email 103978 0
pepa.bruce@mrinz.ac.nz
Contact person for public queries
Name 103979 0
Dr Pepa Bruce
Address 103979 0
Medical Research Institute of New Zealand
Level 7, CSB Building
Wellington Hospital
Riddiford St, Newtown
Wellington 6021
Country 103979 0
New Zealand
Phone 103979 0
+64 4 805 0246
Fax 103979 0
Email 103979 0
pepa.bruce@mrinz.ac.nz
Contact person for scientific queries
Name 103980 0
Dr Pepa Bruce
Address 103980 0
Medical Research Institute of New Zealand
Level 7, CSB Building
Wellington Hospital
Riddiford St, Newtown
Wellington 6021
Country 103980 0
New Zealand
Phone 103980 0
+64 4 805 0246
Fax 103980 0
Email 103980 0
pepa.bruce@mrinz.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data underlying published results only.
When will data be available (start and end dates)?
Data will be available immediately following publication; no end date determined.
Available to whom?
Only researchers who provide a methodologically sound proposal, assessed on a case-by-case basis at the discretion of the Sponsor.
Available for what types of analyses?
Only to achieve the aims of the approved proposal.
How or where can data be obtained?
Access subject to approvals by Sponsor.

Contact details:
Professor Richard Beasley
Medical Research Institute of New Zealand

Postal Address:
Private Bag 7902, Wellington 6242

Physical Address:
Level 7, CSB Building
Wellington Hospital
Riddiford St, Newtown
Wellington 6021
New Zealand

Telephone: +64 4 805 0238
What supporting documents are/will be available?
No other documents available
Summary results
No Results