Dataset Information

Add-on LABA in a separate inhaler as asthma step-up therapy versus increased dose of ICS or ICS/LABA combination inhaler.

ABSTRACT: Asthma management guidelines recommend adding a long-acting ?2-agonist (LABA) or increasing the dose of inhaled corticosteroid (ICS) as step-up therapy for patients with uncontrolled asthma on ICS monotherapy. However, it is uncertain which option works best, which ICS particle size is most effective, and whether LABA should be administered by separate or combination inhalers. This historical, matched cohort study compared asthma-related outcomes for patients (aged 12-80?years) prescribed step-up therapy as a ?50% extrafine ICS dose increase or add-on LABA, via either a separate inhaler or a fine-particle ICS/LABA fixed-dose combination (FDC) inhaler. Risk-domain asthma control was the primary end-point in comparisons of cohorts matched for asthma severity and control during the baseline year. After 1:2 cohort matching, the increased extrafine ICS versus separate ICS+LABA cohorts included 3232 and 6464 patients, respectively, and the fine-particle ICS/LABA FDC versus separate ICS+LABA cohorts included 7529 and 15?058 patients, respectively (overall mean age 42?years; 61-62% females). Over one outcome year, adjusted OR (95% CI) for achieving asthma control were 1.25 (1.13-1.38) for increased ICS versus separate ICS+LABA and 1.06 (1.05-1.09) for ICS/LABA FDC versus separate ICS+LABA. For patients with asthma, increased dose of extrafine-particle ICS, or add-on LABA via ICS/LABA combination inhaler, is associated with significantly better outcomes than ICS+LABA via separate inhalers.

SUBMITTER: Price DB

PROVIDER: S-EPMC5005184 | biostudies-literature | 2016 Apr

REPOSITORIES: biostudies-literature

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Add-on LABA in a separate inhaler as asthma step-up therapy <i>versus</i> increased dose of ICS or ICS/LABA combination inhaler.

Price David B DB Colice Gene G Israel Elliot E Roche Nicolas N Postma Dirkje S DS Guilbert Theresa W TW van Aalderen Willem M C WM Grigg Jonathan J Hillyer Elizabeth V EV Thomas Victoria V Martin Richard J RJ

ERJ open research 20160401 2

Asthma management guidelines recommend adding a long-acting β<sub>2</sub>-agonist (LABA) or increasing the dose of inhaled corticosteroid (ICS) as step-up therapy for patients with uncontrolled asthma on ICS monotherapy. However, it is uncertain which option works best, which ICS particle size is most effective, and whether LABA should be administered by separate or combination inhalers. This historical, matched cohort study compared asthma-related outcomes for patients (aged 12-80 years) prescr ...[more]

PMID: 27730200

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Project description:INTRODUCTION:Products based on inhaled corticosteroid (ICS)/long-acting β2 agonist (LABA) combinations may provide different clinical benefits. This study was conducted to compare the rapid effects of three such combination products: formoterol/fluticasone (FFC) aerosol (pMDI), formoterol/budesonide (FBC) dry powder inhaler (DPI), and vilanterol/fluticasone furoate (VFC) DPI. METHODS:The study design was a three-armed, randomized, crossover study. Patients included in the study had stable moderate asthma, defined as an Asthma Control Questionnaire (ACQ) score ≤ 0.75, and were undergoing step 2 or 3 asthma treatment as defined by JGL2015. Subjects were treated with fluticasone propionate inhaled via Diskus® during a 2-week washout period before randomization. At visit 2, subjects were randomly assigned in a 1:1:1 ratio to FFC, FBC, or VFC, and evaluated for changes in pulmonary function over time. At visits 3 and 4, the treatment was switched to another ICS/LABA combination in a crossover manner after a 1-week washout period. Spirometry was performed pre-dose and at 3, 10, and 30 min post-dose, and forced oscillation was implemented pre-dose and at 1, 7, 15, and 60 min post-dose. RESULTS:Fifteen outpatients (63.3 ± 9.5 years, ACQ: 0.13 ± 0.19) completed the study. ∆FEV1 at 3 min did not significantly differ among the three groups. Significant increases in FEV1 and %FEV1 from baseline were observed in the FFC (p = 0.004, 0.003), FBC (p = 0.014, 0.011), and VFC (p = 0.032, 0.023) groups at 30 min. Improvements in respiratory resistance at 5-20 Hz from baseline at 60 min, resonant frequency, respiratory system reactance at 5 Hz, and low-frequency reactance area from baseline were observed at 1 min in the FFC group (p = 0.014, 0.002, 0.027, 0.018, respectively). CONCLUSION:FFC administered using a pMDI showed favorable delivery to peripheral airways and significantly more rapid action promptly after inhalation as compared with other ICS/LABA preparations inhaled using a DPI, thus broadening the potential therapeutic options for asthma. TRIAL REGISTRATION NUMBER:UMIN000029379. FUNDING:Kyorin Pharmaceutical Co., Ltd.

Project description:ObjectivesTo evaluate through a systematic review the effectiveness of electronic methods in monitoring adherence to regular inhaled corticosteroids (ICS) alone or in combination with long-acting β2-agonists (LABAs) and their effect on clinical outcomes.DesignA narrative systematic review.Data sourcesMEDLINE, EMBASE, Cochrane Database of Systematic Reviews and Web of Science were searched through up to 10 July 2022.Eligibility criteriaWe included peer-reviewed studies of qualitative and quantitative outcomes that compared the effect of electronic methods to routine non-electronic monitoring intervention or placebo among children and adults with asthma on medication adherence rates to regular ICS alone or in combination with LABA, asthma control and asthma exacerbations.Data extraction and synthesisData extraction was performed according to a predetermined sheet specific to the review objectives. The risk of bias was assessed using the Cochrane Risk of Bias Tool for randomised controlled trials and the Risk of Bias in Systematic Reviews tool for systematic reviews. Meta-analysis was not possible based on the findings of the scoping search; however, a narrative review was performed to allow for the grouping of results based on asthma inhaler adherence rates, asthma control and exacerbations.ResultsSix articles comprising 98 studies published from 1998 to 2022 in the USA, Canada and the UK were included. Compared with the control, electronic monitoring devices (EMDs) showed a 23% adherence improvement, mean difference (MD) of 23%, 95% CI 10.84 to 34.16, p=0.0002. Asthmatic children were 1.5 times more likely to be adherent using EMDs compared with non-EMD users (RR=1.5, 95% CI 1.19 to 1.9) (p<0.001). Mobile devices and text message reminders (MHealth) showed a 12% adherence improvement (MD 12%, 95% CI 6.22 to 18.03) (p<0.0001), alongside a small to medium improvement in asthma control (standardised mean difference (SMD) 0.31, 95% CI 0.17 to 0.44), small improvement in asthma-related quality of life (SMD 0.26) (p=0.007) and variable risk reduction in asthma exacerbations for digital health (risk ratio 0.53, 95% CI 0.32 to 0.91) (p=0.02) compared with EMDs, which showed insignificant differences (risk ratio 0.89, 95% CI 0.45 to 1.75) (p=0.72). Technologies combined yielded variable adherence effects, with an SMD for eHealth of 0.41, 95% CI 0.02 to 0.79, and MD for digital health was 14.66% higher than the control, 95% CI 7.74 to 21.57. Heterogeneity between studies was significant (eHealth I2=98%, digital I2=94%).ConclusionElectronic methods improved adherence to inhaled medications in asthma. EMDs appear to be the most effective technology, followed by mHealth. The adherence improvement was associated with a small clinical improvement. There was inconsistent overlapping of terminology describing electronic methods that require standardisation. Data on the cost-effectiveness of electronic devices and their utilisation in severe asthma are lacking and require further research.Prospero registration numberCRD42022303069.

Dataset Information

Add-on LABA in a separate inhaler as asthma step-up therapy versus increased dose of ICS or ICS/LABA combination inhaler.

Publications

Add-on LABA in a separate inhaler as asthma step-up therapy <i>versus</i> increased dose of ICS or ICS/LABA combination inhaler.

Similar Datasets

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