scholarly journals Investigation of two treatment regimens in adults with mild asthma

2021 ◽  
Author(s):  
◽  
Christina Baggott
Keyword(s):  
Treatment Regimen ◽  
Controlled Trial ◽  
Symptom Relief ◽  
Asthma Management ◽  
Shortness Of Breath ◽  
Asthma Treatment ◽  
Steroid Dose ◽  
Asthma Exacerbations ◽  
Randomised Controlled ◽  
Beta2 Agonist

<p>Introduction  In adults with mild-moderate asthma, poor adherence to daily maintenance inhaled corticosteroids (ICS) leads to increased asthma symptoms and risk of asthma exacerbations. There is evidence that symptom-driven use of a combination ICS plus a fast-onset long-acting beta2-agonist (LABA) inhaler taken as needed may be an alternative to daily maintenance ICS plus as-needed short-acting beta2-agonists (SABA). Through four studies: The PRACTICAL study (a randomised controlled trial) and three sub-studies nested within it, this thesis aims to investigate the efficacy of as-needed ICS-formoterol (a fast-onset LABA), exposure to and patterns of ICS and beta2-agonist use, and patient preferences for and priorities concerning their asthma management.     Methods  The PRACTICAL study was a 52 week, open label, parallel group, multicentre, superiority, randomised controlled trial conducted at 15 sites throughout New Zealand. Adults aged 18-75 with a diagnosis of asthma who were taking SABA for symptom relief with or without low dose maintenance ICS were recruited. Participants were randomised 1:1 to either as-needed budesonide-formoterol (200/6mcg) one actuation for symptom relief or budesonide (200mcg) one actuation twice a day plus as-needed terbutaline (250mcg) two actuations for symptom relief. A sub-group of 110 participants had electronic inhaler monitors attached to their study inhalers which captured the time and date of every inhaler actuation. At their final study visit a total of 407 participants were eligible to complete a survey on their treatment preferences and experiences of their study randomised treatment, and a discrete choice experiment to determine their priorities for attributes of asthma management including; treatment regimen, shortness of breath, steroid dose and likelihood of an asthma flare-up.     Results  The PRACTICAL study found the rate of severe exacerbations per patient per year was lower in participants randomised to as-needed budesonide-formoterol than participants randomised to maintenance budesonide (absolute rate per patient per year 0.119 vs 0.172; relative rate 0.69; 95%CI 0.48-1.00; p=0.049).   Within the electronic monitoring sub-study, exposure to ICS was significantly lower in the group randomised to as-needed budesonide-formoterol with a mean daily ICS dose of 176.0mcg versus 302.5mcg in those randomised to maintenance budesonide (difference -126.5mcg per day; 95%CI -171.0 to -81.9; p<0.001). Use of as-needed budesonide-formoterol was associated with extended periods of no ICS use (median 156 days vs 22 days respectively) and more days where ≥4, 6 or 8 actuations of ICS were taken than maintenance budesonide.  Participants’ preference for either as-needed or maintenance treatment was strongly associated with randomised treatment; 90% randomised to as-needed budesonideformoterol preferred their randomised treatment compared to 60% of those randomised to maintenance budesonide, odds ratio for association between randomised treatment and preference was 13.3 (95%CI 7.1 to 24.7; p<0.001).  The DCE found that amount of shortness of breath was the most important attribute of asthma treatment to all participants. However, the relative importance of other attributes, particularly type of treatment regimen, varied depending on whether the participants had previously stated a preference for as-needed or maintenance treatment.     Discussion  In adults with mild-moderate asthma, as-needed budesonide-formoterol is more effective at preventing severe asthma exacerbations than maintenance budesonide at a significantly lower exposure to ICS, despite long periods of no ICS use. This suggests that timing of ICS dose and titrating it in response to symptoms is more important than total dose. If participants have experienced as-needed budesonide-formoterol, they prefer it over maintenance budesonide suggesting this new approach to asthma treatment will be acceptable to patients. Control of shortness of breath was the most important attribute of asthma treatment to all patients. However, participants who preferred as-needed treatment were more willing to trade-off likelihood of an asthma flare up and steroid dose for their preferred treatment regimen. Knowledge of patient preferences and priorities for treatment, together with knowledge of regimen characteristics can be used in discussion with patients to determine the most appropriate regimen for them.</p>

scholarly journals Investigation of two treatment regimens in adults with mild asthma

2021 ◽  
Author(s):  
◽  
Christina Baggott
Keyword(s):  
Treatment Regimen ◽  
Controlled Trial ◽  
Symptom Relief ◽  
Asthma Management ◽  
Shortness Of Breath ◽  
Asthma Treatment ◽  
Steroid Dose ◽  
Asthma Exacerbations ◽  
Randomised Controlled ◽  
Beta2 Agonist

<p>Introduction  In adults with mild-moderate asthma, poor adherence to daily maintenance inhaled corticosteroids (ICS) leads to increased asthma symptoms and risk of asthma exacerbations. There is evidence that symptom-driven use of a combination ICS plus a fast-onset long-acting beta2-agonist (LABA) inhaler taken as needed may be an alternative to daily maintenance ICS plus as-needed short-acting beta2-agonists (SABA). Through four studies: The PRACTICAL study (a randomised controlled trial) and three sub-studies nested within it, this thesis aims to investigate the efficacy of as-needed ICS-formoterol (a fast-onset LABA), exposure to and patterns of ICS and beta2-agonist use, and patient preferences for and priorities concerning their asthma management.     Methods  The PRACTICAL study was a 52 week, open label, parallel group, multicentre, superiority, randomised controlled trial conducted at 15 sites throughout New Zealand. Adults aged 18-75 with a diagnosis of asthma who were taking SABA for symptom relief with or without low dose maintenance ICS were recruited. Participants were randomised 1:1 to either as-needed budesonide-formoterol (200/6mcg) one actuation for symptom relief or budesonide (200mcg) one actuation twice a day plus as-needed terbutaline (250mcg) two actuations for symptom relief. A sub-group of 110 participants had electronic inhaler monitors attached to their study inhalers which captured the time and date of every inhaler actuation. At their final study visit a total of 407 participants were eligible to complete a survey on their treatment preferences and experiences of their study randomised treatment, and a discrete choice experiment to determine their priorities for attributes of asthma management including; treatment regimen, shortness of breath, steroid dose and likelihood of an asthma flare-up.     Results  The PRACTICAL study found the rate of severe exacerbations per patient per year was lower in participants randomised to as-needed budesonide-formoterol than participants randomised to maintenance budesonide (absolute rate per patient per year 0.119 vs 0.172; relative rate 0.69; 95%CI 0.48-1.00; p=0.049).   Within the electronic monitoring sub-study, exposure to ICS was significantly lower in the group randomised to as-needed budesonide-formoterol with a mean daily ICS dose of 176.0mcg versus 302.5mcg in those randomised to maintenance budesonide (difference -126.5mcg per day; 95%CI -171.0 to -81.9; p<0.001). Use of as-needed budesonide-formoterol was associated with extended periods of no ICS use (median 156 days vs 22 days respectively) and more days where ≥4, 6 or 8 actuations of ICS were taken than maintenance budesonide.  Participants’ preference for either as-needed or maintenance treatment was strongly associated with randomised treatment; 90% randomised to as-needed budesonideformoterol preferred their randomised treatment compared to 60% of those randomised to maintenance budesonide, odds ratio for association between randomised treatment and preference was 13.3 (95%CI 7.1 to 24.7; p<0.001).  The DCE found that amount of shortness of breath was the most important attribute of asthma treatment to all participants. However, the relative importance of other attributes, particularly type of treatment regimen, varied depending on whether the participants had previously stated a preference for as-needed or maintenance treatment.     Discussion  In adults with mild-moderate asthma, as-needed budesonide-formoterol is more effective at preventing severe asthma exacerbations than maintenance budesonide at a significantly lower exposure to ICS, despite long periods of no ICS use. This suggests that timing of ICS dose and titrating it in response to symptoms is more important than total dose. If participants have experienced as-needed budesonide-formoterol, they prefer it over maintenance budesonide suggesting this new approach to asthma treatment will be acceptable to patients. Control of shortness of breath was the most important attribute of asthma treatment to all patients. However, participants who preferred as-needed treatment were more willing to trade-off likelihood of an asthma flare up and steroid dose for their preferred treatment regimen. Knowledge of patient preferences and priorities for treatment, together with knowledge of regimen characteristics can be used in discussion with patients to determine the most appropriate regimen for them.</p>

scholarly journals Dexamethasone versus prednisone for children receiving asthma treatment in the paediatric inpatient population: protocol for a feasibility randomised controlled trial

BMJ Open ◽  
2018 ◽  
Vol 8 (12) ◽  
pp. e025630 ◽  
Author(s):  
Catherine M Pound ◽  
Jaime McDonald ◽  
Ken Tang ◽  
Gillian Seidman ◽  
Radha Jetty ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Clinical Outcome ◽  
Controlled Trial ◽  
Asthma Treatment ◽  
Treatment Regimens ◽  
Asthma Exacerbations ◽  
Feasibility Randomised Controlled Trial ◽  
Short Course ◽  
Inpatient Population ◽  
Randomised Controlled

IntroductionAsthma exacerbations are a leading cause of paediatric hospitalisations. Corticosteroids are key in the treatment of asthma exacerbations. Most current corticosteroids treatment regimens for children admitted with asthma exacerbation consist of a 5-day course of prednisone or prednisolone. However, these medications are associated with poor taste and significant vomiting, resulting in poor compliance with the treatment course. While some centres already use a short course of dexamethasone for treating children hospitalised with asthma, there is no evidence to support this practice in the inpatient population.Methods and analysisThis single-site, pragmatic, feasibility randomised controlled trial will determine the feasibility of a non-inferiority trial, comparing two treatment regimens for children admitted to the hospital and receiving asthma treatment. Children 18 months to 17 years presenting to a Canadian tertiary care centre will be randomised to receive either a short course of dexamethasone or a longer course of prednisone/prednisolone once admitted to the inpatient units. The primary clinical outcome for this feasibility study will be readmission to hospital or repeat emergency department visits, or unplanned visits to primary healthcare providers for asthma symptoms within 4 weeks of hospital discharge. Feasibility outcomes will include recruitment and allocation success, compliance with study procedures, retention rate, and safety and tolerability of study medications. We plan on recruiting 51 children, and between-group comparisons of the clinical outcome will be conducted to gain insights on probable effect sizes.Ethics and disseminationResearch Ethics Board approval has been obtained for this study. The results of this study will inform a multisite trial comparing prednisone/prednisolone to dexamethasone in inpatient asthma treatment, which will have the potential to improve the delivery of asthma care, by improving compliance with a mainstay of treatment. Results will be disseminated through peer-reviewed publications, organisations and meetings.Trial registration numberNCT03133897; Pre-results.

Feasibility study of a communication and education asthma intervention for general practitioners in Australia

2010 ◽  
Vol 16 (1) ◽  
pp. 75 ◽  
Author(s):  
Smita Shah ◽  
Brett G. Toelle ◽  
Susan M. Sawyer ◽  
Jessica K. Roydhouse ◽  
Peter Edwards ◽  
...  
Keyword(s):  
General Practitioners ◽  
Controlled Trial ◽  
Communication Strategies ◽  
Asthma Management ◽  
Doctor Patient Communication ◽  
Children With Asthma ◽  
The Usa ◽  
Randomised Controlled ◽  
Communication Behaviours ◽  
The Impact

The Physician Asthma Care Education (PACE) program significantly improved asthma prescribing and communication behaviours of primary care paediatricians in the USA. We tested the feasibility and acceptability of a modified PACE program with Australian general practitioners (GP) and measured its impact on self-reported consulting behaviours in a pilot study. Recruitment took place through a local GP division. Twenty-five GP completed two PACE Australia workshops, which incorporated paediatric asthma management consistent with Australian asthma guidelines and focussed on effective communication strategies. Program feasibility, usefulness and perceived benefit were measured by questionnaires before the workshop and 1 month later, and an evaluation questionnaire after each workshop. GP were universally enthusiastic and supportive of the workshops. The most useful elements they reported were communication skills, case studies, device demonstrations and the toolkit provided. GP self reports of the perceived helpfulness of the key communication strategies and their confidence in their application and reported frequency of use increased significantly after the workshops. The PACE program shows promise in improving the way in which Australian GP manage asthma consultations, particularly with regard to doctor–patient communication. The impact of the modified PACE Australia program on the processes and outcomes of GP care of children with asthma is now being measured in a randomised controlled trial.

Clinical efficacy of a dry extract of five herbal drugs in acute viral rhinosinusitis

2012 ◽  
Vol 50 (4) ◽  
pp. 417-426
Author(s):  
R. Jund ◽  
M. Mondigler ◽  
H. Steindl ◽  
H. Stammer ◽  
P. Stierna ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Symptom Relief ◽  
Secondary Outcome ◽  
Number Needed To Treat ◽  
Symptom Duration ◽  
Serious Adverse Events ◽  
Dry Extract ◽  
End Of Treatment ◽  
Bno 1016 ◽  
Randomised Controlled

Objective: A herbal drug combination (Dry Extract BNO 1016) has been assessed for efficacy and tolerability in patients with acute viral rhinosinusitis. Methodology: In this randomised, controlled trial patients with symptom duration of up to 3 days, mild to moderate facial pain and a Major Symptom Score (MSS) between 8 and 12 were treated for 15 days with BNO 1016 or placebo (coated tablets administered orally). Primary efficacy endpoint was mean MSS at end of treatment. Secondary outcome measures included treatment response and changes in paranasal sinuses assessed by ultrasonography. Results: Treatment resulted in clinically relevant, significant differences in mean MSS for BNO 1016 versus placebo. BNO 1016 provided symptom relief two days earlier than placebo. The number needed to treat for healing is 8. BNO 1016 was superior regarding responder rates at Day 10 and Day 14 and percentage of patients without signs of acute viral rhinosinusitis assessed by ultrasonography at end of treatment. BNO 1016 was well tolerated; no serious adverse events were reported. Conclusion: The herbal dry extract BNO 1016 is efficacious and well tolerated in patients with acute viral rhinosinusitis. Trial registration: ClinicalTrials.gov (ClinicalTrials.gov Identifier: NCT01146860; EudraCT: 2009-016682-28).

scholarly journals e-Monitoring of Asthma Therapy to Improve Compliance in children (e-MATIC): a randomised controlled trial

2016 ◽  
Vol 48 (3) ◽  
pp. 758-767 ◽  
Author(s):  
Erwin C. Vasbinder ◽  
Lucas M.A. Goossens ◽  
Maureen P.M.H. Rutten-van Mölken ◽  
Brenda C.M. de Winter ◽  
Liset van Dijk ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Asthma Control ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Quality ◽  
Asthma Exacerbations ◽  
Sms Reminders ◽  
Randomised Controlled

Real-time medication monitoring (RTMM) is a promising tool for improving adherence to inhaled corticosteroids (ICS), but has not been sufficiently tested in children with asthma. We aimed to study the effects of RTMM with short message service (SMS) reminders on adherence to ICS, asthma control, asthma-specific quality of life and asthma exacerbation rate; and to study the associated cost-effectiveness.In a multicentre, randomised controlled trial, children (aged 4–11 years) using ICS were recruited from five outpatient clinics and were given an RTMM device for 12 months. The intervention group also received tailored SMS reminders, sent only when a dose was at risk of omission. Outcome measures were adherence to ICS (RTMM data), asthma control (childhood asthma control test questionnaire), quality of life (paediatric asthma quality of life questionnaire) and asthma exacerbations. Costs were calculated from a healthcare and societal perspective.We included 209 children. Mean adherence was higher in the intervention group: 69.3%versus57.3% (difference 12.0%, 95% CI 6.7%–17.7%). No differences were found for asthma control, quality of life or asthma exacerbations. Costs were higher in the intervention group, but this difference was not statistically significant.RTMM with tailored SMS reminders improved adherence to ICS, but not asthma control, quality of life or exacerbations in children using ICS for asthma.

What matters most to patients when choosing treatment for mild–moderate asthma? Results from a discrete choice experiment

Thorax ◽  
2020 ◽  
Vol 75 (10) ◽  
pp. 842-848
Author(s):  
Christina Baggott ◽  
Paul Hansen ◽  
Robert J Hancox ◽  
Jo Katherine Hardy ◽  
Jenny Sparks ◽  
...  
Keyword(s):  
Treatment Regimen ◽  
Discrete Choice Experiment ◽  
Discrete Choice ◽  
Choice Experiment ◽  
Controlled Trial ◽  
Final Analysis ◽  
Mild Asthma ◽  
Relative Importance ◽  
Shortness Of Breath ◽  
Moderate Asthma

BackgroundAn as-needed combination preventer and reliever regimen was recently introduced as an alternative to conventional daily preventer treatment for mild asthma. In a subgroup analysis of the PRACTICAL study, a pragmatic randomised controlled trial of budesonide–formoterol reliever therapy versus maintenance budesonide plus terbutaline reliever therapy in adults with mild asthma, we recently reported that about two-thirds preferred as-needed combination preventer and reliever therapy. The aim of this study was to determine the relative importance of attributes associated with these two asthma therapies in this subgroup of participants who indicated their preferred treatment in the PRACTICAL study.MethodsAt their final study visit, a subgroup of participants indicated their preferred treatment and completed a discrete choice experiment using the Potentially All Pairwise RanKings of all possible Alternatives method and 1000minds software. Treatment attributes and their levels were selected from measurable study outcomes, and included: treatment regimen, shortness of breath, steroid dose and likelihood of asthma flare-up.ResultsThe final analysis dataset included 288 participants, 64% of whom preferred as-needed combination preventer and reliever. Of the attributes, no shortness of breath and lowest risk of asthma flare-up were ranked highest and second highest, respectively. However, the relative importance of the other two attributes varied by preferred therapy: treatment regimen was ranked higher by participants who preferred as-needed treatment than by participants who preferred maintenance treatment.ConclusionsKnowledge of patient preferences for treatment attributes together with regimen characteristics can be used in shared decision-making regarding choice of treatment for patients with mild–moderate asthma.Trial registration numberACTRN12616000377437.

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