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

Scicchitano, R.; Aalbers, Rick; Ukena, D.; Manjra, Ahmed I.; Fouquert, L; Centanni, Stefano; Lp, Boulet; Naya, IP; Hultquist, Christer

doi:10.1185/030079904x2051

Cited by 202 publications

(247 citation statements)

References 14 publications

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“…Symptom-free days. Compared with two-to fourfold higher doses of ICS, treatment with budesonide/formoterol maintenance and reliever therapy leads to significant increases in symptom-free days (35,42,43). Budesonide/ formoterol maintenance and reliever therapy was also significantly superior compared with the same dose of budesonide/formoterol plus SABA (35,45).…”

Section: Improving Daily Asthma Control and Reducing Impairmentmentioning

confidence: 90%

“…GINA guidelines define asthma control as no troublesome symptoms day or night, near-normal lung function, very limited reliever use and no severe exacerbations (1). In all studies, patients using budesonide/formoterol maintenance and reliever therapy are controlled, on the majority of days, with a lower (35,(42)(43)(44)47) or similar (46) mean daily dose of ICS compared with those on other therapies. In the study by Kuna et al (44), patients receiving budesonide/formoterol maintenance and reliever therapy were reliever-free on 56.0% of days, compared with 59.1% and 57.8% of days in patients receiving conventional treatment (salmeterol/ fluticasone plus terbutaline or budesonide/formoterol plus terbutaline, respectively) (44).…”

Section: Improving Daily Asthma Control and Reducing Impairmentmentioning

confidence: 99%

“…An overview of these clinical trials is provided in Table 1 and they are individually discussed in detail elsewhere (35,(42)(43)(44)(45)(46)(47).…”

Section: Formoterol As a Fast-acting Relievermentioning

confidence: 99%

“…Evidence of the efficacy and safety of maintenance and reliever therapy with budesonide/formoterol Five large-scale, double-blind clinical trials and one openlabel, dose-titration study, of 6-12 months duration and including over 15 000 asthma patients aged ‡ 12 years, have demonstrated the superior efficacy and safety of budesonide/formoterol maintenance and reliever therapy compared with two-to fourfold higher doses of ICS (budesonide) plus SABA (35,42,43) and similar or higher doses of maintenance budesonide/formoterol (35,44,45) or salmeterol/fluticasone (44,46,47) plus SABA as needed. An overview of these clinical trials is provided in Table 1 and they are individually discussed in detail elsewhere (35,(42)(43)(44)(45)(46)(47).…”

Section: Formoterol As a Fast-acting Relievermentioning

confidence: 99%

“…Compared with two-to fourfold higher doses of ICS and similar doses of budesonide/ formoterol plus SABA, treatment with budesonide/formoterol maintenance and reliever therapy reduces the percentage of nights with awakenings (35,43,45). In patients who were all receiving budesonide/formoterol as maintenance, those receiving budesonide/formoterol as needed had reduced night-time awakenings by 3% compared with terbutaline as needed (P = 0.0025) and by 2% (equivalent to seven nights per year) (P = 0.018) compared with formoterol as needed (45).…”

Section: Improving Daily Asthma Control and Reducing Impairmentmentioning

confidence: 99%

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Budesonide/formoterol for maintenance and reliever therapy in the management of moderate to severe asthma

Humbert

Andersson

Buhl³

2008

Allergy

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The Global Initiative for Asthma (GINA) guidelines aim at improving asthma control and preventing future risk. For patients with moderate to severe asthma an inhaled corticosteroid (ICS) or an ICS/long‐acting β2‐agonist (LABA) combination with a short‐acting β2‐agonist (SABA) as reliever is recommended. Despite the availability of effective maintenance therapies, a large proportion of patients still fail to achieve guideline‐defined asthma control, and overuse of SABA reliever medication at the expense of ICS is commonly observed. New simplified treatment approaches may offer a solution and assist physicians to achieve overall asthma control. One such treatment approach, which is recommended in the GINA guidelines, is budesonide/formoterol for both maintenance and reliever therapy. This treatment strategy significantly reduces the rate of severe asthma exacerbations compared with ICS/LABA plus SABA and achieves equivalent daily symptom control compared with higher doses of ICS/LABA plus separate SABA for relief. These benefits are achieved at a lower overall steroid load, and budesonide/formoterol maintenance and reliever therapy is well tolerated in patients with moderate to severe asthma. This review discusses current asthma management in patients with moderate to severe disease and examines the evidence for alternative asthma management approaches.

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Section: Improving Daily Asthma Control and Reducing Impairmentmentioning

confidence: 90%

Section: Improving Daily Asthma Control and Reducing Impairmentmentioning

confidence: 99%

“…An overview of these clinical trials is provided in Table 1 and they are individually discussed in detail elsewhere (35,(42)(43)(44)(45)(46)(47).…”

Section: Formoterol As a Fast-acting Relievermentioning

confidence: 99%

Section: Formoterol As a Fast-acting Relievermentioning

confidence: 99%

Section: Improving Daily Asthma Control and Reducing Impairmentmentioning

confidence: 99%

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Budesonide/formoterol for maintenance and reliever therapy in the management of moderate to severe asthma

Humbert

Andersson

Buhl³

2008

Allergy

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Association of Inhaled Corticosteroids and Long-Acting β-Agonists as Controller and Quick Relief Therapy With Exacerbations and Symptom Control in Persistent Asthma

Sobieraj

Weeda

Nguyen

et al. 2018

JAMA

269

209

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Addition of long-acting beta2-agonists to inhaled steroids as first line therapy for persistent asthma in steroid-naive adults and children

Chróinín

Greenstone

Lasserson

et al. 2009

Cochrane Database of Systematic Reviews

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Background Consensus statements recommend the addition of long-acting inhaled ß2-agonists (LABA) only in asthmatic patients who are inadequately controlled on inhaled corticosteroids (ICS). It is not uncommon for some patients to be commenced on ICS and LABA together as initial therapy. Objectives To compare the efficacy of combining inhaled corticosteroids with long-acting ß2-agonists (ICS+LABA) with inhaled corticosteroids alone (ICS alone) in steroid-naive children and adults with persistent asthma. We assessed two protocols: (1) LABA + ICS versus a similar dose of ICS (comparison 1) and (2) LABA + ICS versus a higher dose of ICS (comparison 2). Search methods We identified randomised controlled trials through electronic database searches (May 2008). Selection criteria Randomised trials comparing ICS + LABA with ICS alone in children and adults with asthma who had no inhaled corticosteroids in the preceding 28 days prior to enrolment. Data collection and analysis Each author assessed studies independently for risk of bias and extracted data. We obtained confirmation from the trialists when possible. The primary endpoint was rate of patients with one or more asthma exacerbations requiring rescue systemic corticosteroids. Results are expressed as relative risks (RR) for dichotomous data and as mean differences (MD) or standardised mean differences (SMD) for continuous data. Main results Twenty-eight study comparisons drawn from 27 trials (22 adult; five paediatric) met the review entry criteria (8050 participants). Baseline data from the studies indicated that trial populations had moderate or mild airway obstruction (FEV1 65% predicted), and that they were symptomatic prior to randomisation. In comparison 1, the combination of ICS and LABA was not associated with a significantly lower risk of patients with exacerbations requiring oral corticosteroids (RR 1.04; 95% confidence interval (CI) 0.73 to 1.47) or requiring hospital admissions (RR 0.38; 95% CI 0.09 to 1.65) compared to a similar dose of ICS alone. The combination of LABA and ICS led to a significantly greater improvement from baseline in FEV1 (0.12 L/sec; 95% CI 0.07 to 0.17), in symptoms (SMD −0.26; 95% CI −0.37 to −0.14) and in rescue ß2-agonist use (−0.41 puffs/day; 95% CI −0.73 to −0.09) compared with a similar dose of ICS alone. There was no significant group difference in the risk of serious adverse events (RR 1.15; 95% CI 0.64 to 2.09), any adverse events (RR 1.02; 95% CI 0.96 to 1.09), study withdrawals (RR 0.95; 95% CI 0.82 to 1.11), or withdrawals due to poor asthma control (RR 0.94; 95% CI 0.63 to 1.41). In comparison 2, the combination of LABA and ICS was associated with a higher risk of patients requiring oral corticosteroids (RR 1.24; 95% CI 1 to 1.53) and study withdrawal (RR 1.31; 95% CI 1.07 to 1.59) than a higher dose of ICS alone. For every 100 patients treated over 43 weeks, nine patients using a higher dose ICS compared to 11 (95% CI 9 to 14) on LABA and ICS suffered one or more exacerbations requiring rescue oral cortico...

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

Abstract: 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.

Cited by 202 publications

References 14 publications

Budesonide/formoterol for maintenance and reliever therapy in the management of moderate to severe asthma

Budesonide/formoterol for maintenance and reliever therapy in the management of moderate to severe asthma

Association of Inhaled Corticosteroids and Long-Acting β-Agonists as Controller and Quick Relief Therapy With Exacerbations and Symptom Control in Persistent Asthma

Addition of long-acting beta2-agonists to inhaled steroids as first line therapy for persistent asthma in steroid-naive adults and children

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