Single-inhaler Therapy Research Articles

Breaking down barriers to COPD management in primary care: applying the updated 2023 Canadian Thoracic Society guideline for pharmacotherapy.

Chronic obstructive pulmonary disease (COPD) is a highly prevalent yet under-recognized and sub-optimally managed disease that is associated with substantial morbidity and mortality. Primary care providers (PCPs) are at the frontlines of COPD management, and they play a critical role across the full spectrum of the COPD patient journey from initial recognition and diagnosis to treatment optimization and referral to specialty care. The Canadian Thoracic Society (CTS) recently updated their guideline on pharmacotherapy in patients with stable COPD, and there are several key changes that have a direct impact on COPD management in the primary care setting. Notably, it is the first guideline to formally make recommendations on mortality reduction in COPD, which elevates this disease to the same league as other chronic diseases that are commonly managed in primary care and where optimized pharmacotherapy can reduce all-cause mortality. It also recommends earlier and more aggressive initial maintenance inhaler therapy across all severities of COPD, and preferentially favors the use of single inhaler therapies over multiple inhaler regimens. This review summarizes some of the key guideline changes and offers practical tips on how to implement the new recommendations in primary care. It also addresses other barriers to optimal COPD management in the primary care setting that are not addressed by the guideline update and suggests strategies on how they could be overcome.

Accuracy of Inhaler Use in COPD Patients and Factors Affecting It

Background: An inhaler is a type of dosage form used in the treatment of chronic obstructive pulmonary disease (COPD). The inhaler has a unique technique for use; however, the percentage of accuracy in inhaler use is still low. Proper inhaler use is expected to improve quality of life and decrease the occurrence of exacerbations. This study aimed to observe the percentage of accuracy in using inhalers and the factors that influence it.Method: This study was conducted with a cross-sectional design on COPD patients in two different hospitals. Primary data were collected using a questionnaire. The accuracy of inhaler use was assessed using a checklist.Results: The total number of patients in this study was 110, with an average age of 62 years. Patients were given single inhaler therapy, which included Dry Powder Inhalers (DPI) for 34 patients with 70.7% accuracy, Pressurized Metered-Dose Inhalers (pMDI) for 9 persons with 45.74% accuracy, and Soft Mist Inhalers (SMI) for one person with 66.67% accuracy. Furthermore, patients who used a combination of pMDI and DPI inhalers had an accuracy value of 68.53%, while a combination of pMDI and SMI had an accuracy value of 72.72%. The stage with the lowest level of accuracy in the pMDI-type inhaler used alone was exhaling before the inhaler was supplied.Conclusion: According to the findings, the accuracy of inhaler use in COPD patients is still relatively low. Furthermore, gender is a factor that has a statistically significant relationship with inhaler accuracy.

Therapeutic Response to Single-Inhaler Triple Therapies in Moderate-to-Severe COPD.

COPD is characterized by progressive and irreversible air flow limitations. Single-inhaler therapies (SITTs) incorporating an inhaled corticosteroid, a long-acting muscarinic antagonist, and a long-acting β2-agonist have been shown to effectively alleviate symptoms and improve lung function. Fluticasone-furoate/umeclidinium/vilanterol (F/U/V) and budesonide/glycopyrronium/formoterol (B/G/F) are available as SITT in Japan. However, the clinical differences between these 2 combinations and the predictors of their proper use have not been established. This study aimed to identify the subject characteristics that could predict the effectiveness of inhaler therapy. We assessed the pulmonary function test results of subjects with COPD before and one month after using F/U/V and B/G/F as SITT. Subjects with a difference of 100 mL or more in the FEV1 after treatment with pre-SITT were extracted and divided into the F/U/V effect and no-effect group and B/G/F effect and no-effect group to examine the factors associated with positive outcomes with each inhaler. F/U/V and B/G/F significantly improved the inspiratory capacity (IC), %IC, FVC, and %FEV1 when compared to pre-intervention values (P < .001, P = .001, P = .007, P = .009, respectively, for F/U/V; and P = .006, P = .008, P = .038, P = .005, respectively, for B/G/F). Factors associated with FEV1 improvement in F/U/V included lower %IC (odds ratio 0.97 [95% CI 0.94-0.99], P = .03) and a higher modified Medical Research Council (mMRC) dyspnea score (2.36 [1.27-4.70], P < .01). In addition, a higher %IC (1.03 [1.00-1.06], P = .02) and lower mMRC dyspnea score (0.55 [0.28-0.99], P = .041) were predictors for the effectiveness of B/G/F. Our results showed that SITT significantly improved the IC, %IC, FVC, and %FEV1 when compared to pre-intervention and that F/U/V was more effective in subjects with severe symptoms, whereas B/G/F was more effective in subjects with mild symptoms.

Ефективність та безпечність терапії пацієнтів з бронхіальною астмою з використанням єдиного інгалятора

Abstract. Selection of adequate therapy for bronchial asthma (BA) by a doctor directly affects not only the level of control over the patient’s symptoms, his compliance, but also improves the patient’s quality of life and avoids his disability. Doctors and patients are already accustomed to the fact that inhaled glucocorticosteroids (ICS) are the most effective anti-inflammatory drugs for the treatment of asthma. However, the response to ICS varies among patients, so some may require a medium-dose ICS if their asthma is not controlled or if they have asthma exacerbations. Among the existing following fixed combinations of ICS/ long-acting β2 -agonists (LABA), which are approved for regular use from the 3rd step of BA treatment, only two are currently available in Ukraine — budesonide + formoterol and fluticasone propionate + salmeterol. GINA recommends the use of an ICS/formoterol combination as the preferred single maintenance and palliative therapy because studies have shown that use of this therapy as a patient-initiated symptomatic palliative therapy when symptoms worsen provides comparable benefit to short-acting β2 -agonists (SABA) for the relief of smooth muscle dysfunction. in addition to providing corticosteroids with an increase in local protection in case of increased inflammation of the respiratory tract Budesonide/formoterol fixed-dose single-inhaler therapy for basic therapy and symptom relief helps achieve the main goals of AD treatment, namely achieving symptom control and reducing future risks, fully consistent with the latest GINA guidelines. This regimen, in comparison with alternative regimens of therapy with fixed doses of other combined drugs and SABA as needed, reduces the risk of exacerbations, gives a lower steroid burden on the patient with a comparable level of BA control.

The pharmacoeconomics of the state-of-the-art drug treatments for asthma: a systematic review.

Asthma is a chronic disease characterized by significant morbidities and mortality, with a large impact on socio-economic resources and a considerable burden on health-care systems. In the standard care of asthma, inhaled corticosteroids (ICS) associated with long-acting β-adrenoceptor agonists (LABA) are a reliable and often cost-effective choice, especially if based on the single inhaler therapy (SIT) strategy; however, in a subset of patients it is not possible to reach an adequate asthma control. In these cases, it is possible to resort to other pharmacologic options, including corticosteroids (OCS) or biologics. Unfortunately, OCS are associated with important side effects, whilst monoclonal antibodies (mAbs) allow excellent results, even if far more expensive. Up to now, the economic impact of asthma has not been compared with equivalent indicators in several studies. In fact, a significant heterogeneity of the cost analysis is evident in literature, for which the assessment of the real cost-effectiveness of asthma therapies is remarkably complex. To maximize the cost-effectiveness of asthma strategies, especially of biologics, attention must be paid on phenotyping and identification of predictors of response. Several studies were included, involving comparative analysis of drug treatments for asthma, comparative analysis of the costs and consequences of therapies, measurement and evaluation of direct drug costs, and the reduction of health service use. The initial research identified 389 articles, classified by titles and abstracts. A total of 311 articles were excluded as irrelevant and 78 articles were selected. Pharmacoeconomic studies on asthma therapies often report conflicting data also due to heterogeneous indicators and different populations examined. A careful evaluation of the existing literature is extremely important, because the scenario is remarkably complex, with an attempt to homogenize and interpret available data. Based on these studies, the improvement of prescriptive appropriateness and the reduction of the use of healthcare resources thanks to controller medications and to innovative therapies such as biologics partially reduce the economic burden of these treatments. A multidisciplinary stakeholder approach can also be extremely helpful in deciding between the available options and thus optimizing healthcare resources.

Single-Inhaler Triple Therapy and Health-Related Quality of Life in COPD: The IMPACT Study.

IntroductionThe phase 3 InforMing the PAthway of COPD (chronic obstructive pulmonary disease) Treatment (IMPACT) trial, single-inhaler therapy with fluticasone furoate (FF) 100 μg, umeclidinium (UMEC) 62.5 μg, and vilanterol (VI) 25 μg demonstrated a reduction in the rate of moderate or severe exacerbations compared with FF/VI or UMEC/VI in patients with symptomatic COPD at risk of exacerbations. This article reports additional evidence of improvements in symptoms and health-related quality of life (HRQoL) with FF/UMEC/VI compared with either FF/VI or UMEC/VI from the IMPACT study.MethodsPatient-reported HRQoL assessments and symptom measures included as pre-specified IMPACT end points were the St George's Respiratory Questionnaire (SGRQ), COPD Assessment Test (CAT), and Baseline Dyspnea Index (BDI) as the anchor for the Transitional Dyspnea Index (TDI) focal score (BDI/TDI) in a subset of patients enrolled at study sites in North America and Europe. Change from baseline was assessed at weeks 4, 28, and 52.ResultsThe intent-to-treat population included 10,355 patients (TDI population: 5058 patients). Clinically meaningful improvements in SGRQ total score between baseline and week 52 favored FF/UMEC/VI over FF/VI (− 1.8 units, p < 0.001) and UMEC/VI (− 1.8 units, p < 0.001). Similar improvements in the CAT and TDI focal score were also observed with FF/UMEC/VI versus FF/VI or UMEC/VI.ConclusionsThis study demonstrates that in patients with symptomatic COPD at risk of exacerbations, once-daily FF/UMEC/VI, compared with FF/VI or UMEC/VI, improves patient-perceived HRQoL and symptoms.Trial Registration NumberNCT02164513.

Impact of Single Combination Inhaler versus Multiple Inhalers to Deliver the Same Medications for Patients with Asthma or COPD: A Systematic Literature Review.

With increasing choice of medications and devices for asthma and chronic obstructive pulmonary disease (COPD) treatment, comparative evidence may inform treatment decisions. This systematic literature review assessed clinical and economic evidence for using a single combination inhaler versus multiple inhalers to deliver the same medication for patients with asthma or COPD. In 2016, Embase, PubMed and the Cochrane library were searched for publications reporting studies in asthma or COPD comparing a single-inhaler combination medicine with multiple inhalers delivering the same medication. Publications included English-language articles published since 1996 and congress abstracts since 2013. Clinical, economic and adherence endpoints were assessed. Of 2031 abstracts screened, 18 randomized controlled trials (RCTs) in asthma and four in COPD, nine retrospective and three prospective observational studies in asthma, and four observational studies in COPD were identified. Of these, five retrospective and one prospective study in asthma, and two retrospective studies in COPD reported greater adherence with a single inhaler than multiple inhalers. Nine observational studies reported significantly (n=7) or numerically (n=2) higher rates of adherence with single- versus multiple-inhaler therapy. Economic analyses from retrospective and prospective studies showed that use of single-inhaler therapies was associated with reduced healthcare resource use (n=6) and was cost-effective (n=5) compared with multiple-inhaler therapies. Findings in 18 asthma RCTs and one prospective study reporting lung function, and six RCTs reporting exacerbation rates, showed no significant differences between a single inhaler and multiple inhalers. This was in contrast to several observational studies reporting reductions in healthcare resource use or exacerbation events with single-inhaler treatment, compared with multiple inhalers. Retrospective and prospective studies showed that single-inhaler use was associated with decreased healthcare resource utilization and improved cost-effectiveness compared with multiple inhalers. Lung function and exacerbation rates were mostly comparable in the RCTs, possibly due to study design.

The IMPACT of triple versus dual single-inhaler therapy on exacerbations of COPD.

In the IMPACT trial, triple inhalation therapy resulted in a lower rate of moderate or severe COPD exacerbations compared with either dual therapy with ICS/LABA or LAMA/LABA, but pneumonia rates were increased. http://ow.ly/pYJn30mgpFp

Combination formoterol and budesonide as maintenance and reliever therapy versus combination inhaler maintenance for chronic asthma in adults and children.

Combination formoterol and budesonide as maintenance and reliever therapy versus combination inhaler maintenance for chronic asthma in adults and children.

Combination formoterol and budesonide as maintenance and reliever therapy versus current best practice (including inhaled steroid maintenance), for chronic asthma in adults and children.

Combination formoterol and budesonide as maintenance and reliever therapy versus current best practice (including inhaled steroid maintenance), for chronic asthma in adults and children.

The clinical impact of single inhaler therapy in asthma

Clinical & Experimental AllergyVolume 42, Issue 11 p. 1654-1654 Addendum The clinical impact of single inhaler therapy in asthma First published: 29 October 2012 https://doi.org/10.1111/cea.12017Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat No abstract is available for this article. Volume42, Issue11November 2012Pages 1654-1654 RelatedInformation

The clinical impact of single inhaler therapy in asthma

Low-dose budesonide/formoterol combination used in the SMART fashion with symptom-reactive supplemental dosing has been reported to reduce asthma exacerbations as compared to the use of budesonide alone or to lower doses of budesonide/formoterol without supplemental dosing. We undertook to review the non-exacerbation outcomes of SMART therapy and to assess the patient education implications of this treatment strategy. Systematic review. Patients treated with this strategy appear to be under-treated in that the majority fail to achieve guideline-defined control standards. The SMART strategy has not been tested against equivalent or higher doses of budesonide/formoterol given in symptom-prevention fashion. Existing educational strategies that focus on recognition of poor disease control may not be applicable with SMART therapy and the use of action plans has not been clarified with this symptom-reactive strategy. There is some evidence from that the current clinical use of SMART therapy may be contaminated frequently by the concurrent prescription of short-acting bronchodilators. There is no information on long-term outcomes with a symptom-reactive ICS/LABA strategy but the use of the strategy for one year has been associated with rising sputum and airway biopsy eosinophil counts. Despite fewer severe exacerbations with SMART therapy as compared to ICS monotherapy or lower dose ICS/LABA therapy, the strategy produces poor day-to-day control of symptoms and is associated with increasing inflammation. The symptom-reactive strategy described as SMART therapy is associated with poor symptom control of asthma.

Formoterol versus short-acting beta-agonists as relief medication for adults and children with asthma.

Formoterol is a long-acting beta(2)-agonist but because it has a fast onset of action it can also be used as a relief medication. To asses the efficacy and safety of formoterol as reliever therapy in comparison to short-acting beta(2)-agonists in adults and children with asthma. We searched the Cochrane Airways Group Specialised Register and websites of clinical trial registers (for unpublished trial data), and we checked the Food and Drug Administration (FDA) submissions in relation to formoterol. The date of the most recent search was February 2010. Randomised, parallel-arm trials of at least 12 weeks duration in patients of any age and severity of asthma. Studies randomised patients to any dose of as-needed formoterol versus short-acting beta(2)-agonist. Concomitant use of inhaled corticosteroids or other maintenance medication was allowed, as long as this was not part of the randomised treatment regimen. Two authors independently selected trials for inclusion in the review. Outcome data were extracted by one author and checked by the second author. We sought unpublished data on primary outcomes. This review includes eight studies conducted in 22,604 participants (mostly adults). Six studies compared formoterol as-needed to terbutaline whilst two studies compared formoterol with salbutamol as-needed. Background maintenance therapy varied across the trials. Asthma exacerbations and serious adverse events showed a direction of treatment effect favouring formoterol, of which one outcome reached statistical significance (exacerbations requiring a course of oral corticosteroids). In patients on short-acting beta(2)-agonists, 117 people out of 1000 had exacerbations requiring oral corticosteroids over 30 weeks, compared to 101 (95% CI 93 to 108) out of 1000 for patients on formoterol as-needed. In patients on maintenance inhaled corticosteroids there were also significantly fewer exacerbations requiring a course of oral corticosteroids on formoterol as-needed (Peto OR 0.75; 95% CI 0.62 to 0.91). There was one death per 1000 people on formoterol or on short-acting beta(2)-agonists. In adults, formoterol was similar to short-acting beta(2)-agonists when used as a reliever, and showed a reduction in the number of exacerbations requiring a course of oral corticosteroids. Clinicians should weigh the relatively modest benefits of formoterol as-needed against the benefits of single inhaler therapy and the potential danger of long-term use of long-acting beta(2)-agonists in some patients. We did not find evidence to recommend changes to guidelines that suggest that long-acting beta(2)-agonists should be given only to patients already taking inhaled corticosteroids.There was insufficient information reported from children in the included trials to come to any conclusion on the safety or efficacy of formoterol as relief medication for children with asthma.

Combination formoterol and budesonide as maintenance and reliever therapy versus inhaled steroid maintenance for chronic asthma in adults and children.

Traditionally inhaled treatment for asthma has been considered as preventer and reliever therapy. The combination of formoterol and budesonide in a single inhaler introduces the possibility of using a single inhaler for both prevention and relief of symptoms (single inhaler therapy). The aim of this review is to compare formoterol and corticosteroid in single inhaler for maintenance and relief of symptoms with inhaled corticosteroids for maintenance and a separate reliever inhaler. We last searched the Cochrane Airways Group trials register in September 2008. Randomised controlled trials in adults and children with chronic asthma. Two review authors independently assessed studies for inclusion and extracted the characteristics and results of each study. Authors or manufacturers were asked to supply unpublished data in relation to primary outcomes. Five studies on 5,378 adults compared single inhaler therapy with current best practice, and did not show a significant reduction in participants with exacerbations causing hospitalisation (Peto OR 0.59; 95% CI 0.24 to 1.45) or treated with oral steroids (OR 0.83; 95% CI 0.66 to 1.03). Three of these studies on 4281 adults did not show a significant reduction in time to first severe exacerbation needing medical intervention (HR 0.96; 95% CI 0.85 to 1.07). These trials demonstrated a reduction in the mean total daily dose of inhaled corticosteroids with single inhaler therapy (mean reduction ranged from 107 to 267 micrograms/day, but the trial results were not combined due to heterogeneity). The full results from four further studies on 4,600 adults comparing single inhaler therapy with current best practice are awaited.Three studies including 4,209 adults compared single inhaler therapy with higher dose budesonide maintenance and terbutaline for symptom relief. No significant reduction was found with single inhaler therapy in the risk of patients suffering an asthma exacerbation leading to hospitalisation (Peto OR 0.56; 95% CI 0.28 to 1.09), but fewer patients on single inhaler therapy needed a course of oral corticosteroids (OR 0.54; 95% CI 0.45 to 0.64). These results translate into an eleven month number needed to treat of 14 (95% CI 12 to 18), to prevent one patient being treated with oral corticosteroids for an exacerbation. The run-in for these studies involved withdrawal of long-acting beta(2)-agonists, and patients were recruited who were symptomatic during run-in.One study included children (N = 224), in which single inhaler therapy was compared to higher dose budesonide. There was a significant reduction in participants who needed an increase in their inhaled steroids with single inhaler therapy, but there were only two hospitalisations for asthma and no separate data on courses of oral corticosteroids. Less inhaled and oral corticosteroids were used in the single inhaler therapy group and the annual height gain was also 1 cm greater in the single inhaler therapy group, [95% CI 0.3 to 1.7 cm].There was no significant difference found in fatal or non-fatal serious adverse events for any of the comparisons. Single inhaler therapy can reduce the risk of asthma exacerbations needing oral corticosteroids in comparison with fixed dose maintenance inhaled corticosteroids. Guidelines and common best practice suggest the addition of regular long-acting beta(2)-agonist to inhaled corticosteroids for uncontrolled asthma, and single inhaler therapy has not been demonstrated to significantly reduce exacerbations in comparison with current best practice, although results of five large trials are awaiting full publication. Single inhaler therapy is not currently licensed for children under 18 years of age in the United Kingdom.

ABS29: The SMART plan: development of a symptom-based asthma action plan for single inhaler therapy

Introduction:Asthma patients are often uncontrolled on current asthma therapies [1], most patients in general practice do not have asthma action plans [2] and guideline recommendations are not being closely followed [3]. Negative attitudes towards personal asthma action plans (PAAPs) may be one reason for this obvious reluctance to adopt them in routine clinical practice. However, patients have positive attitudes towards PAAPs, if these are straightforward [4]. The introduction of single-inhaler therapy provides a timely opportunity to develop and evaluate a simple asthma action plan using only one inhaler only to achieve control. There have been no previous studies of asthma action plans for single-inhaler therapy. The literature is particularly weak on the criteria and timing of stepping up and down.Aims and objectives:To identify the key components of a symptom-driven asthma action plan which covers what symptoms should drive up therapy in the short-term and long-term, and what should signal stepping down medication for patients taking single inhaler therapy with flexible dosing.Subjects and methods:The Delphi Technique [5] was used to establish a consensus opinion from 30 asthma experts (GPs, practice nurses, hospital specialists). The resulting plan will be piloted with asthma patients, to check for acceptability and clarity of language, and modified accordingly. Results andConclusions:We will present the SMART plan, discuss the next stages of this project and use of the SMART plan. Conflict of interest and funding None.

Inhaled Glucocorticosteroid and Long-Acting ??2-Adrenoceptor Agonist Single-Inhaler Combination for Both Maintenance and Rescue Therapy

Despite aggressive fixed-dose (FD) combination therapy with inhaled glucocorticosteroids (ICS) and long acting beta(2)-adrenoceptor agonists (LABA), many patients with asthma remain suboptimally controlled, based on the need for rescue therapy and rates of severe exacerbations. The strategy of adjustable maintenance dosing (AMD) involves adjustment of the maintenance dose, (using a single combination [budesonide/formoterol] inhaler, Symbicort((R))) in response to variability of asthma control over time. The AMD strategy, like the FD approach, involves the use of a short-acting beta(2)-adrenoceptor agonist (SABA) for rapid relief of bronchospasm. The dose-response characteristics of budesonide/formoterol make the AMD strategy a feasible option that cannot be exploited with the combination of salmeterol/fluticasone propionate (Advair((R))). Several studies suggest that the AMD strategy is superior to a FD approach in terms of overall asthma control.Budesonide/formoterol in a single inhaler is as effective as albuterol (salbutamol) for relief of acute asthma episodes, a feature that makes it possible to use this combination for both maintenance and reliever therapy without the need for the use of a SABA. The single-inhaler strategy has been shown to be safe and more efficacious than FD therapy. In particular, the COSMOS study has demonstrated that exacerbation burden is reduced more effectively when the combination (budesonide/formoterol) single inhaler is used for both maintenance and relief compared with FD therapy with salmeterol/fluticasone and albuterol for rescue in patients with moderate-to-severe asthma. These findings suggest that we will have to reconsider our definition of reliever therapy for patients that require long-term therapy with combination ICS and LABA.The concept of single-inhaler therapy represents a paradigm shift in asthma management that has been validated in several large studies involving thousands of patients. The single-inhaler strategy represents one of the most significant advances in asthma management in many years, and one that appears ideal for adoption in primary care.

Symbicort single inhaler therapy simplifies asthma management

Symbicort single inhaler therapy simplifies asthma management

Efficacy and safety of budesonide/formoterol single inhaler therapy versus a higher dose of budesonide in moderate to severe asthma

SUMMARYObjectives: This study evaluated the efficacy and safety of a novel asthma management strategy – budesonide/formoterol for both maintenance and symptom relief (Symbicort Single Inhaler Therapy*) – compared with a higher maintenance dose of budesonide in patients with moderate to severe asthma.Methods: This was a 12-month, randomised, double-blind, parallel-group study. Symptomatic patients with asthma (n = 1890; mean age 43 years [range 11 years–80 years], mean baseline forced expiratory volume in 1 s [FEV1] 70% of predicted, mean inhaled corticosteroid [ICS] dose 746 µg/day) received either budesonide (160 µg, 2 inhalations twice daily) plus terbutaline 0.4 mg as needed or a daily maintenance dose of budesonide/formoterol (160/4.5 µg, 2 inhalations once daily) with additional inhalations of budesonide/formoterol 160/4.5 µg as needed. Time to first severe exacerbation (hospitalisation/emergency room [ER] treatment or systemic steroids due to asthma worsening or a fall in morning peak expiratory flow [PEF] to ≤ 70% of baseline on 2 consecutive days) was the primary outcome variable.Results: A total of 1890 patients were randomised, of whom 1563 (83%) had severe asthma. The time to first severe exacerbation was prolonged by budesonide/formoterol single inhaler therapy ( p < 0.001) compared with a higher dose of budesonide. The risk of having a severe exacerbation was 39% lower with budesonide/ formoterol single inhaler therapy compared with budesonide ( p < 0.001). The number needed to treat to prevent one severe exacerbation per year with budesonide/formoterol compared with budesonide was 5. The budesonide/formoterol group had 45% fewer severe exacerbations requiring medical intervention per patient compared with the budesonide group ( p < 0.001). Budesonide/formoterol patients had fewer hospitalisations/ER treatments (15 vs 25 events, respectively [descriptive statistics]) and fewer treatment days with systemic steroids (1776 days vs 3177 days, respectively [descriptive statistics]) compared with budesonide patients. Budesonide/formoterol single inhaler therapy patients used less as-needed medication compared with budesonide patients (0.90 vs 1.42 inhalations/day; p < 0.001). The mean daily ICS dose was lower in the budesonide/formoterol group than in the budesonide group (466 µg/day vs 640 µg/day). Over the 12-month study period, the budesonide/formoterol group achieved asthma control sufficient to not require any additional as-needed medication on 60% of days. Overall, budesonide/formoterol single inhaler therapy gave 31 more asthma control days (a night and day with no asthma symptoms and no as-needed medication use) per patient-year and 12 additional undisturbed nights per patient-year compared with a higher dose of budesonide. Both treatments were well tolerated.Conclusion: Budesonide/formoterol single inhaler therapy has the potential to provide a complete asthma management approach with one inhaler, demonstrating a high level of efficacy in patients with moderate to severe asthma.

Budesonide/formoterol single inhaler therapy superior in asthma

Budesonide/formoterol single inhaler therapy superior in asthma

Single inhaler Therapy with budesonide/formoterol provides superior asthma control compared with fixed dosing with budesonide plus terbutaline as needed

Rationale Single inhaler Therapy with budesonide/formoterol allows patients with asthma to take a once-daily (qd) base dose plus additional inhalations as needed. This study compared Single inhaler Therapy with budesonide/formoterol with higher doses of budesonide qd plus terbutaline as needed. Methods In this 6-month, randomized, double-blind, parallel-group study, patients with asthma (n=697; mean age 38 [range 11-79] years), mean baseline FEV 1 75% of predicted normal, and mean ICS dose 348μg/day) received 2 inhalations qd of either budesonide/formoterol in a single inhaler (Symbicort ®) 80/4.5μg plus additional inhalations as needed, or budesonide 160μg with inhaled terbutaline 0.4mg as needed. Main outcomes were lung function, as-needed medication use, and severe exacerbations (morning PEF ≤70% of baseline on 2 consecutive days, hospitalization/emergency room (ER) treatment, or oral steroids due to asthma). Results Patients receiving budesonide/formoterol showed greater improvements in morning PEF from run-in than those receiving budesonide (+34.5 vs +9.5L/min; p<0.001). The incidence of severe exacerbations was 54% lower in the budesonide/formoterol group compared with budesonide alone (43 vs 94 events, respectively). Budesonide/formoterol patients required 384 fewer treatment days with oral steroids compared with those receiving budesonide (114 vs 498, respectively) and experienced fewer hospitalizations/ER treatments (1 vs 10, respectively). Budesonide/formoterol patients took significantly fewer as-needed inhalations during the treatment period compared with budesonide patients (1.04 vs 1.48 inhalations/day; p<0.001). Conclusions Single inhaler Therapy with a once-daily base dose of budesonide/formoterol plus additional inhalations as needed provides superior asthma control and reduces the incidence of severe exacerbations compared with a higher fixed dose of budesonide plus terbutaline.