Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001176752
Ethics application status
Approved
Date submitted
11/08/2022
Date registered
31/08/2022
Date last updated
6/09/2022
Date data sharing statement initially provided
31/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Asthma Review and Management in Community Pharmacy
Scientific title
Feasibility of Asthma Review and Management in New Zealand Community Pharmacy - a Single Cohort, Open Label, Non-Randomised Pilot Study
Secondary ID [1] 307736 0
Nil Known
Universal Trial Number (UTN)
U1111-1271-6704
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma Reviews 327312 0
Condition category
Condition code
Respiratory 324443 324443 0 0
Asthma
Public Health 324608 324608 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will examine the feasibility and logistics of undertaking a community pharmacist-led review of mild asthma, with the capacity to adjust participant Anti-Inflammatory Reliever (AIR) algorithm guidelines, known as AIR Therapy steps under a primary care physician standing order.
Participants will attend two visits to a study pharmacy at baseline and week 12 post-intervention commencement. The study will be conducted via face-to-face interaction between participants and community-pharmacist investigators with remote participant-reported outcomes collected in between study visits in electronic diaries.
Notes on Questionnaires:
The Asthma Control Measure (ACM) is a validated questionnaire used to assess asthma control over the past four weeks (1,2). This is a self-reported questionnaire completed by the participant, consisting of 5 questions, with five possible answers, corresponding to ratings on a scale of 1 to 5. The total score of the scale is proportional to worsening asthma control (1,2). The DPI technique questionnaire involves the scoring of each step involved in the administration of a DPI (3) this is cored by the pharmacist. The Inhaler Technique Questionnaire (InTeQ) is a subjective participant-reported inhaler technique questionnaire. The questionnaire is designed to be a participant tool for reporting and training in inhaler techniques. InTeQ uses 5 questions, with a 5-point Likert scale (4). EuroQol-5D Questionnaire (EQ-5D-5L) is a validated health-related quality of life questionnaire for the assessment of asthma patients (5,6). The EQ-5D-5L is a patient-reported outcome measure that consists of 5 questions with Likert Responses and a visual analog scale. The descriptive system covers 5 aspects of the participant’s health; mobility, self-care, usual activities, pain or discomfort, and anxiety and depression, with 5 possible answers for each question. The visual analog scale is used to capture the participant’s total health on the day of completion.
Participant-reported medication use and adherence will be tracked based a five-point-Likert question. “How often do you not take your medication as prescribed?” adapted from work by Mehuys et al (7).

The below outline data collected at each time point;
Week 1 – Study Visit 1 (Approx. 45 mins in Pharmacy)
• Informed consent
• Inclusion/Exclusion criteria determined
• Contact and demographic information
• Medical history (incl Medication history)
• ACM
• EQ-5D-5L
• Inhaler technique scoring and review (DPI).
• InTe Participant Reviewed inhaler technique.
• Self-reported medication use
• Assessment of AIR step (according to AIR algorithm) and adjustment under a standing order if required.
• Book follow-up visit for 12 weeks

Participants reported electronic remote diaries - at weeks 4 and 8 (Approx. 20 mins)
• The participant will complete the diary via digital link (email).
• AIR Steps questionnaire (according to AIR algorithm)
• ACM
• EQ-5D-5L
• InTeQ Participant Reviewed inhaler technique
• Self-reported medication use
• New medical events and new therapies will be recorded.

Week 12 – Study Visit 2 (Approx. 30 mins in Pharmacy)
• ACM
• EQ-5D-5L
• Inhaler technique scoring and review (DPI)
• InTeQ Participant Reviewed inhaler technique
• New medical events and new therapies will be recorded.
• Assessment of AIR step (according to AIR algorithm) and adjustment under a standing order if required.
• Self-reported medication use
• Assessment of participant reported value of community pharmacy-led asthma review (through Questionnaire developed for study)
• Acceptability to participants of pharmacist-led review and capacity to adjust treatment of mild asthma (through Likert Scale Questionnaire developed for the study,

End of the Study (Conducted by Pharmacists and Primary care physicians via electronic database approx. 30 mins)
• Acceptability to pharmacist investigators (involved in the study) of pharmacist-led review and capacity to adjust treatment of mild asthma (through Narrative Questionnaire) developed for the study.
• Acceptability to primary care physicians (involved in the study) of pharmacist-led review and capacity to adjust treatment of mild asthma (through Narrative Questionnaire) developed for the study.

Pharmacist Training:
Pharmacists participating in the trial will be trained in the study protocol, and execution of AIR therapy adjustments under the standing order, and all associated questionnaires.

Note on Study Intervention:
Doses may be titrated within the pre-defined AIR algorithm steps depending on reported medication use, and control as defined in the standing order. As part of the participants’ diary entries, they will complete the AIR Step questionnaire (AIR algorithm), if indicated that they should change from their current Step, the participant will receive an invitation recommending they seek an asthma review. This can be organized with the PRN investigator or alternatively with their Primary Care Physician, attendance will not be compulsory. All outcomes will be documented within the study database.

References:
1. Lara, M., Edelen, M. O., Eberhart, N. K., Stucky, B. D. & Sherbourne, C. D. Development and validation of the RAND Asthma Control Measure. European Respiratory Journal 44, 1243–1252 (2014).
2. Rudin, R. S., Qureshi, N., Foer, D., Dalal, A. K. & Edelen, M. O. Toward an asthma patient-reported outcome measure for use in digital remote monitoring. Journal of Asthma 1–6 (2021).
3. Santos, D. de O. et al. Atenção farmacêutica ao portador de asma persistente: avaliação da aderência ao tratamento e da técnica de utilização dos medicamentos inalatórios. J. bras. pneumol. 36, 14–22 (2010).
4. Lizano-Barrantes, C. et al. The Inhaler Technique Questionnaire (InTeQ): Development and Validation of a Brief Patient-Reported Measure. International Journal of Environmental Research and Public Health 19, 2591 (2022).
5. Hernandez, G. et al. EuroQol (EQ-5D-5L) validity in assessing the quality of life in adults with asthma: cross-sectional study. Journal of medical Internet research 21, e10178 (2019).
6. Szentes, B. L., Schultz, K., Nowak, D., Schuler, M. & Schwarzkopf, L. How does the EQ-5D-5L perform in asthma patients compared with an asthma-specific quality of life questionnaire? BMC pulmonary medicine 20, 1–11 (2020).
7. Mehuys, E. et al. Effectiveness of pharmacist intervention for asthma control improvement. European Respiratory Journal 31, 790–799 (2008).
Intervention code [1] 324334 0
Treatment: Other
Comparator / control treatment
No control group - this is a single cohort, open-label, non-randomised pilot study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332248 0
To inform recruitment rates, assessed based on the proportion of eligible asthmatics contacted that enroll into the study. Assessed using audit of study records at the end of the study.
Timepoint [1] 332248 0
End of study.
Secondary outcome [1] 412693 0
To evaluate the overall acceptability to participants of pharmacist-led review and capacity to adjust treatment of mild asthma. Assessed using Five-point Likert scale questions.
Timepoint [1] 412693 0
Week 12 post-intervention commencement.
Secondary outcome [2] 412694 0
To evaluate the overall acceptability to pharmacist investigators of pharmacist-led review and capacity to adjust treatment of mild asthma. Assessed using narrative questionnaire.
Timepoint [2] 412694 0
End of study
Secondary outcome [3] 412695 0
To evaluate the overall acceptability to the GP of the pharmacist-led review and capacity to adjust treatment of mild asthma. Assessed by a narrative questionnaire.
Timepoint [3] 412695 0
End of study.
Secondary outcome [4] 412696 0
Assessment of asthma control over a 12-week period. Assessed based on change in Asthma Control Measure (ACM) score compared to baseline.
Timepoint [4] 412696 0
Baseline, Week 4, Week 8 and Week 12 post-intervention commencement.
Secondary outcome [5] 412697 0
Assessment of asthma control over a 12-week period. Assessed based on proportion of participants requiring treatment escalation. Assessed through audit of individual study records.
Timepoint [5] 412697 0
Baseline and week 12 post-intervention commencement.
Secondary outcome [6] 412698 0
Assessment of asthma control over a 12-week period. Assessed based on proportion of participants requiring treatment escalation outside of AIR steps. Assessed based on audit of participant study records.
Timepoint [6] 412698 0
Week 12 post-intervention commencement.
Secondary outcome [7] 412699 0
Assessment of asthma control over a 12-week period. Assessed based on the number of severe exacerbations. Assessed based on audit of participant study records.
Timepoint [7] 412699 0
Week 12 post-intervention commencement.
Secondary outcome [8] 412700 0
Assessment of asthma control over a 12-week period. Assessed based on the number of moderate asthma exacerbations. Assessed based on audit of participant study records.
Timepoint [8] 412700 0
Week 12 post-intervention commencement.
Secondary outcome [9] 412701 0
Assessment of asthma control over a 12-week period. Assessed based on the number of asthma related emergency department or hospital admissions. Assessed based on audit of participant study records.
Timepoint [9] 412701 0
Week 12 post-intervention commencement.
Secondary outcome [10] 412702 0
Assessments of inhaler technique based on a change in the dry powder inhaler technique score compared to baseline. This assessment is conducted by the study pharmacist.
Timepoint [10] 412702 0
Baseline and 12 weeks post-intervention commencement.
Secondary outcome [11] 412703 0
Participant reported assessment of inhaler technique assessed by change in The Inhaler Technique Questionnaire (InTeQ) from baseline.
Timepoint [11] 412703 0
Baseline, week 4, week4, week8 and week 12 post-intervention commencement.
Secondary outcome [12] 412704 0
Participant reported use of medication to inform on adherence, assessed using Five-point Likert Scale.
Timepoint [12] 412704 0
Baseline, week 4, week 8 and week 12 post-intervention commencement.
Secondary outcome [13] 412705 0
Assessment of the proportion of participants who attended recommended reviews generated from electronic diaries. Assessed based on audit of participant study records.
Timepoint [13] 412705 0
End of study.
Secondary outcome [14] 412706 0
Assessment of participant reported value of community pharmacy led asthma review. Participants will provide binary answers survey questions about their opinion of potential costs this was developed specifically for this study.
Timepoint [14] 412706 0
Week 12 post-intervention commencement.
Secondary outcome [15] 412707 0
Assessment of retention of enrolled participants based on the proportion of participants completing the 12-week review visit. Assessed based on audit of study records.
Timepoint [15] 412707 0
Week 12 post-intervention commencement
Secondary outcome [16] 412708 0
Assessment of recruitment rate from eligible asthmatics based on the proportion of eligible asthmatics contacted that express interest in study enrolment. Assessed based on audit study records.
Timepoint [16] 412708 0
Prescreen
Secondary outcome [17] 412709 0
Assessment of AIR treatment uptake on the General Practice database based on the proportion of General Practice registered asthmatics currently prescribed AIR steps one, two, or three. Assessed based on audit of screening related study records.
Timepoint [17] 412709 0
Prescreen
Secondary outcome [18] 412710 0
Assessment of Short-acting ß-agonist (SABA) monotherapy use for asthma on the General Practice database based on the proportion of General Practice registered asthmatics currently prescribed SABA monotherapy. Assessed based on audit of screening related study records.
Timepoint [18] 412710 0
Prescreen.
Secondary outcome [19] 412711 0
Assessment of quality of life during the study period, assessed based on the change in score of EuroQol-5D Questionnaire (EQ-5D-5L) from baseline.
Timepoint [19] 412711 0
Baseline, Week 4, Week 8 and Week 12 post-intervention commencement
Secondary outcome [20] 412712 0
Assessment of safety for participants based on the number of adverse events of interest and number of serious adverse events of interest.

Budesonide/formoterol 200µg/6µg (Symbicort® Turbuhaler) is a MedSafe registered and approved medicine. All participants will enter already on this specific medication and will remain under the primary care of their primary care physician. The clinical effects of Symbicort® are well understood and documented as a commonly prescribed medication in New Zealand. Therefore, as part of this study it is intended to only collect safety data relating:

- AE’s directly connected to the participants asthma or use of the medication, Symbicort® Turbuhaler.

- Serious Adverse Events of Special Interest (SAESIs) which include;
o Adverse reactions to the study medication
o Death
o Hospitalisation due to events known to be, or putatively associated with the participants asthma or use of the study medication.

For the purposes of this study, these events will be collected through either the primary care physician, or as self-reported by the participant during diary entries, unscheduled visits or at visit 2, with details will be recorded in the database.
Timepoint [20] 412712 0
Week 12 post-intervention commencement.

Eligibility
Key inclusion criteria
Participants are eligible to be included in the study only if all the following criteria apply:
1. Willing and able to provide written informed consent
2. Adults aged 18 to 65 years.
3. Physician diagnosis of asthma.
4. Have a prescription for Budesonide/formoterol 200µg/6µg (Symbicort® Turbuhaler) taken as required, per AIR algorithm step 1.
5. Access to a mobile phone and/or device with internet connectivity to complete remote assessments.
6. Willingness and ability to return for a follow up visit at week 12.
7. Willing to attend the study pharmacy for their asthma reviews throughout the length of the study.
8. Willing and able to comply with the study instructions.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants are excluded from the study if any of the following criteria apply:
1. Other chronic respiratory disease, such as COPD, Interstitial lung disease, etc.
2. Any acute or chronic medical condition that the investigator considers may impact the validity and reliability of the study results.
3. Current use of Budesonide/formoterol 200µg/6µg (Symbicort® Turbuhaler) as maintenance therapy per AIR algorithm step 2 or 3
4. Current use of any other inhaled medication for asthma.
5. Current use of theophylline, leukotriene receptor antagonist, sodium cromoglycate, nedocromil sodium or monoclonal antibody therapy for asthma.
6. Current use or use within the preceding 6 weeks of oral steroids.
7. Cognitive impairment preventing the participant from understanding the trial instructions or requires assistance in management of medications, complete questionnaires, or provide informed consent.
8. Active involvement in any clinical trial, or recent involvement in an interventional trial in the past 12 weeks.

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
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
All participants enrolled in the study will be analysed.

Categorical data will be described by counts and proportions; count data by rates and total counts in relation to observation time; ordinal data by cross-tabulation; summaries and continuous data by mean, SD, median, 25th, and 75th percentiles as the inter-quartile range and range.

The primary outcome is the proportion of participants approached through GP database screening, willing to participate in the proposed full trial. A sample size of 25 participants gives a 95% confidence interval for a proportion of 50% of plus or minus 20%. Coupled with the GP mail-out response rate this will provide informative data on the feasibility of recruiting the required numbers for the full trial.



Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/09/2022
Actual
Date of last participant enrolment
Anticipated
13/03/2023
Actual
Date of last data collection
Anticipated
12/06/2023
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment outside Australia
Country [1] 24939 0
New Zealand
State/province [1] 24939 0
Bay of Plenty and Wellington

Funding & Sponsors
Funding source category [1] 312005 0
Charities/Societies/Foundations
Name [1] 312005 0
New Zealand Pharmacy and Education Research Foundation
Country [1] 312005 0
New Zealand
Funding source category [2] 312006 0
Charities/Societies/Foundations
Name [2] 312006 0
Medical Research Institute of New Zealand
Country [2] 312006 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 Street, Newtown, Wellington 6021
Country
New Zealand
Secondary sponsor category [1] 313502 0
None
Name [1] 313502 0
Address [1] 313502 0
Country [1] 313502 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311427 0
Central Health and Disability Ethics Committee (HDEC)
Ethics committee address [1] 311427 0
Ethics committee country [1] 311427 0
New Zealand
Date submitted for ethics approval [1] 311427 0
05/08/2022
Approval date [1] 311427 0
02/09/2022
Ethics approval number [1] 311427 0
Ref: 2022 FULL 12897

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

Contacts
Principal investigator
Name 121058 0
A/Prof Alex Semprini
Address 121058 0
Medical Research Institute of New Zealand,
Level 7 Clinical Services Building,
Wellington Hospital,
Riddiford Street, Newtown
Wellington, 6021
Country 121058 0
New Zealand
Phone 121058 0
+64 4 805 0260
Fax 121058 0
Email 121058 0
[email protected]
Contact person for public queries
Name 121059 0
Georgina Bird
Address 121059 0
Medical Research Institute of New Zealand,
Level 7 Clinical Services Building,
Wellington Hospital,
Riddiford Street, Newtown
Wellington, 6021
Country 121059 0
New Zealand
Phone 121059 0
+64 4 805 0261
Fax 121059 0
Email 121059 0
[email protected]
Contact person for scientific queries
Name 121060 0
Georgina Bird
Address 121060 0
Medical Research Institute of New Zealand,
Level 7 Clinical Services Building,
Wellington Hospital,
Riddiford Street, Newtown
Wellington, 6021
Country 121060 0
New Zealand
Phone 121060 0
+64 4 805 0261
Fax 121060 0
Email 121060 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD sharing will not occur as pilot study status.


What supporting documents are/will be available?

No Supporting Document Provided



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.