Doubling the Dose of Inhaled Corticosteroid to Prevent Asthma Exacerbations: Randomised Controlled Trial

PEDIATRICS ◽  
2005 ◽  
Vol 116 (Supplement 2) ◽  
pp. 564.2-564
Author(s):  
Elinor Simons ◽  
Robert A. Wood
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Inhaled Corticosteroid ◽  
Asthma Exacerbations ◽  
Randomised Controlled

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.

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.

scholarly journals Description of a randomised controlled trial of inhaled corticosteroid/fast-onset LABA reliever therapy in mild asthma

2016 ◽  
Vol 47 (3) ◽  
pp. 981-984 ◽  
Author(s):  
Richard Beasley ◽  
Ian Pavord ◽  
Alberto Papi ◽  
Helen K. Reddel ◽  
Tim Harrison ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Mild Asthma ◽  
Inhaled Corticosteroid ◽  
Fast Onset ◽  
Randomised Controlled

Self-titration of inhaled corticosteroid and β2-agonist in response to symptoms in mild asthma: a pre-specified analysis from the PRACTICAL randomised controlled trial

2020 ◽  
Vol 56 (4) ◽  
pp. 2000170
Author(s):  
Christina Baggott ◽  
Jo Hardy ◽  
Jenny Sparks ◽  
Mark Holliday ◽  
Daniela Hall ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Median Number ◽  
Mild Asthma ◽  
Severe Exacerbation ◽  
Inhaled Corticosteroid ◽  
Electronic Monitors ◽  
Exacerbation Risk ◽  
Randomised Controlled ◽  
Β2 Agonist

IntroductionIn mild asthma, as-needed budesonide–formoterol is superior or noninferior to maintenance budesonide plus as-needed short-acting β2-agonist in reducing severe exacerbations. In this pre-specified analysis, we investigated patterns of inhaled corticosteroid (ICS) and β2-agonist use in PRACTICAL, a randomised controlled trial.MethodsParticipants were randomised 1:1 to as-needed budesonide–formoterol (200/6 μg Turbuhaler, one actuation) or maintenance budesonide (200 μg Turbuhaler, one actuation twice a day) with as-needed terbutaline (250 μg, two actuations) for 52 weeks. 110 participants had electronic monitors attached to their study inhalers which captured the time and date of every actuation. Key outcome measures were patterns of ICS and β2-agonist use. One actuation of budesonide–formoterol was considered to be an equivalent bronchodilator dose as two actuations of terbutaline.ResultsParticipants randomised to as-needed budesonide–formoterol had more days with no ICS use compared with maintenance budesonide (median total days of no use 156 versus 22 days, respectively), lower median daily budesonide dose (164 versus 328 μg, respectively) and a greater median number of days of ≥4 budesonide actuations (4 versus 1 days, respectively). Participants randomised to as-needed budesonide–formoterol took higher equivalent doses of β2-agonist both overall (median number of actuations 0.8 versus 0.3 per day, respectively) and in response to worsening asthma (total number of “overuse days” of >8 or >16 actuations of budesonide–formoterol or terbutaline 33 versus 10 days, respectively).ConclusionsThe timing of ICS dose when self-titrated to β2-agonist use is more important than total ICS dose in reducing severe exacerbation risk in mild asthma, when associated with greater overall use of as-needed β2-agonist.

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