Efficacy and Safety of Budesonide and Formoterol in One Pressurised Metered-Dose Inhaler in Adults and Adolescents with Moderate to Severe Asthma

Noonan, Michael; Rosenwasser, Lanny J.; Martin, Paula; O’Brien, Christopher; O'Dowd, L.

doi:10.2165/00003495-200666170-00006

Cited by 73 publications

(97 citation statements)

References 27 publications

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“…The predefined criterion of clinical exacerbation included the following subcategories that were not mu- Table I. Study treatments and entry criteria [5][6][7][8] Study Run-in Interventions Race Asthma severity I (NCT00651651) [6] Placebo pMDI bid BUD/FM pMDI 160/9 mg (n = 123) BUD pMDI 160 mg (n = 121) FM DPI 9 mg (n = 114) Placebo (n = 122)…”

Section: Resultsmentioning

confidence: 99%

“…[5][6][7][8] Comparisons among treatment groups of percentages of patients who experienced ‡1 predefined asthma event and of percentages of patients who withdrew because of such an event were performed by w 2 test (study I) or Cochran-Mantel-Haenszel test with adjustment for treatment (studies III and IV) and ICS dose (medium or high; studies II, III, and IV) at study entry.…”

Section: Methodsmentioning

confidence: 99%

“…[2] For the purpose of asthma research protocol development, moderate exacerbation events have been captured using various terminology, such as asthma deterioration, [3] asthma worsenings, [4] and asthma events. [5] Few US studies have evaluated the safety and efficacy of an inhaled corticosteroid (ICS)/long-acting b 2 -adrenergic agonist (LABA) combination therapy in Black or Hispanic patients with asthma. The efficacy of budesonide/formoterol (BUD/FM) pressurized metered-dose inhaler (pMDI) has been evaluated in randomized, double-blind studies in predominantly White patients with mild to moderate asthma [6] and predominantly White, [5] Black, [7] and Hispanic [8] patients with moderate to severe asthma.…”

Section: Introductionmentioning

confidence: 99%

“…[5] Few US studies have evaluated the safety and efficacy of an inhaled corticosteroid (ICS)/long-acting b 2 -adrenergic agonist (LABA) combination therapy in Black or Hispanic patients with asthma. The efficacy of budesonide/formoterol (BUD/FM) pressurized metered-dose inhaler (pMDI) has been evaluated in randomized, double-blind studies in predominantly White patients with mild to moderate asthma [6] and predominantly White, [5] Black, [7] and Hispanic [8] patients with moderate to severe asthma. Results for a predefined asthma event definition, which encompass moderate to severe asthma deteriorations, are presented as these findings have not been presented previously in detail or compared across patient populations.…”

Section: Introductionmentioning

confidence: 99%

“…Additional details of the individual studies, including study design and methods, have been previously described. [5][6][7][8] This analysis of predefined asthma events (table II) includes data from patients aged ‡12 years with asthma who were enrolled in randomized, double-blind, 12-week US studies that differed according to baseline asthma severity and/or race or ethnicity (table III). Only the BUD/FM and BUD treatment arms, which were common to all four studies, are presented; these studies were not originally powered for comparison of asthma events.…”

Section: Introductionmentioning

confidence: 99%

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The Effect of Budesonide/Formoterol Pressurized Metered-Dose Inhaler on Predefined Criteria for Worsening Asthma in Four Different Patient Populations with Asthma

et al. 2012

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Background: Previous studies have shown disparities between Black and Hispanic patients compared with other populations in response to asthma medications. Objective: The aim of this analysis was to assess the effect of budesonide/ formoterol pressurized metered-dose inhaler (BUD/FM pMDI) and BUD on predefined criteria for asthma worsening, an asthma control metric generally aligned with definitions of moderate asthma exacerbations, across four different populations. Methods: Data were from four 12-week, randomized, double-blind, US studies of BUD/FM pMDI treatment in patients aged 12 years or older with varying asthma severities and of varying races. Predefined asthma events and withdrawals due to predefined events were assessed as secondary study endpoints. Study I (NCT00651651) includes data from predominantly White patients with mild to moderate asthma who were randomized to BUD/FM pMDI 160/9 mg twice daily (bid; n = 123) or BUD pMDI 160 mg bid (n = 121). Study II (NCT00652002) includes data from predominantly White patients with moderate to severe asthma who were randomized to BUD/FM pMDI 320/9 mg bid (n = 124) or BUD pMDI 320 mg bid (n = 109). Study III (NCT00702325) included self-reported Black patients with moderate to severe asthma who were randomized to BUD/FM pMDI 320/9 mg bid (n = 153) or BUD dry powder inhaler 360 mg bid (n = 148). Study IV (NCT00419757) included self-reported Hispanic patients with moderate to severe asthma who were randomized to BUD/FM pMDI 320/9 mg bid (n = 127) or BUD pMDI 320 mg bid (n = 123). Patients were to be withdrawn from the studies if they developed an asthma event, as determined by predefined criteria, except for night-time awakenings, where withdrawal was left to the study physician's judgment.

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Section: Resultsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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The Effect of Budesonide/Formoterol Pressurized Metered-Dose Inhaler on Predefined Criteria for Worsening Asthma in Four Different Patient Populations with Asthma

et al. 2012

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Addition of long-acting beta2-agonists to inhaled corticosteroids versus same dose inhaled corticosteroids for chronic asthma in adults and children

Ducharme

Chróinín

Greenstone

et al. 2010

Cochrane Database of Systematic Reviews

132

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Background Long-acting inhaled ß2-adrenergic agonists (LABAs) are recommended as ’add-on’ medication to inhaled corticosteroids (ICS) in the maintenance therapy of asthmatic adults and children aged two years and above. Objectives To quantify in asthmatic patients the safety and efficacy of the addition of LABAs to ICS in patients insufficiently controlled on ICS alone. Search methods We identified randomised controlled trials (RCTs) through electronic database searches (the Cochrane Airways Group Specialised Register, MEDLINE, EMBASE and CINAHL), bibliographies of RCTs and correspondence with manufacturers until May 2008. Selection criteria We included RCTs if they compared the addition of inhaled LABAs versus placebo to the same dose of ICS in children aged two years and above and in adults. Data collection and analysis Two review authors independently assessed studies for methodological quality and extracted data. We obtained confirmation from the trialists when possible. The primary endpoint was the relative risk (RR) of asthma exacerbations requiring rescue oral corticosteroids. Secondary endpoints included pulmonary function tests (PFTs), rescue beta2-agonist use, symptoms, withdrawals and adverse events. Main results Seventy-seven studies met the entry criteria and randomised 21,248 participants (4625 children and 16,623 adults). Participants were generally symptomatic at baseline with moderate airway obstruction despite their current ICS regimen. Formoterol or salmeterol were most frequently added to low-dose ICS (200 to 400 μg/day of beclomethasone (BDP) or equivalent) in 49% of the studies. The addition of a daily LABA to ICS reduced the risk of exacerbations requiring oral steroids by 23% from 15% to 11% (RR 0.77, 95% CI 0.68 to 0.87, 28 studies, 6808 participants). The number needed to treat with the addition of LABA to prevent one use of rescue oral corticosteroids is 41 (29, 72), although the event rates in the ICS groups varied between 0% and 38%. Studies recruiting adults dominated the analysis (6203 adult participants versus 605 children). The subgroup estimate for paediatric studies was not statistically significant (RR 0.89, 95% CI 0.58 to 1.39) and includes the possibility of the superiority of ICS alone in children. Higher than usual dose of LABA was associated with significantly less benefit. The difference in the relative risk of serious adverse events with LABA was not statistically significant from that of ICS alone (RR 1.06, 95% CI 0.87 to 1.30). The addition of LABA led to a significantly greater improvement in FEV1 (0.11 litres, 95% 0.09 to 0.13) and in the proportion of symptom-free days (11.88%, 95% CI 8.25 to 15.50) compared to ICS monotherapy. It was also associated with a reduction in the use of rescue short-acting ß2-agonists (−0.58 puffs/day, 95% CI −0.80 to −0.35), fewer withdrawals due to poor asthma control (RR 0.50, 95% CI 0.41 to 0.61), and fewer withdrawals due to any reason (RR 0.80, 95% CI 0.75 to 0.87). There was no statistically significant group difference ...

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Regular treatment with formoterol for chronic asthma: serious adverse events

Cates

Lasserson

2008

Cochrane Database of Systematic Reviews

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In comparison with placebo, we have found an increased risk of serious adverse events with regular formoterol, and this does not appear to be abolished in patients taking inhaled corticosteroids. The effect on serious adverse events of regular formoterol in children was greater than the effect in adults, but the difference between age-groups was not significant.Data on all-cause serious adverse events should be more fully reported in journal articles, and not combined with all adverse events or limited to those events that are thought by the investigator to be drug-related.

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Efficacy and Safety of Budesonide and Formoterol in One Pressurised Metered-Dose Inhaler in Adults and Adolescents with Moderate to Severe Asthma

Abstract: In this population, twice-daily budesonide/formoterol pMDI provides asthma control significantly greater than the monocomponents or placebo and comparable with budesonide pMDI + formoterol DPI. Safety profiles were similar for all treatments.

Cited by 73 publications

References 27 publications

The Effect of Budesonide/Formoterol Pressurized Metered-Dose Inhaler on Predefined Criteria for Worsening Asthma in Four Different Patient Populations with Asthma

The Effect of Budesonide/Formoterol Pressurized Metered-Dose Inhaler on Predefined Criteria for Worsening Asthma in Four Different Patient Populations with Asthma

Addition of long-acting beta2-agonists to inhaled corticosteroids versus same dose inhaled corticosteroids for chronic asthma in adults and children

Regular treatment with formoterol for chronic asthma: serious adverse events

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