Safety of formoterol Turbuhaler(R) at cumulative dose of 90  g in patients with acute bronchial obstruction

Małolepszy, J; Nagy, Gyorgy Boszormenyi; Selroos, Olof; Larsson, P; Brander, R.

doi:10.1183/09031936.01.00251901

Cited by 70 publications

(50 citation statements)

References 18 publications

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“…As formoterol is known to be well tolerated at higher doses [19,20] and to have a defined dose-response with no plateau in effect over the dose range investigated here [10,21], it is possible that a subgroup of patients with partial responses to treatment might have gained from further doses of formoterol and salbutamol. Indeed, in one cumulative-dose study, comparing formoterol Turbuhaler1 with terbutaline Turbuhaler1 in acute asthma, 20 as-needed doses of formoterol up to a maximum of 90 mg were safely administered, with improved tolerability compared with 20 as-needed doses of terbutaline (total dose 10 mg) [20].…”

Section: Discussionmentioning

confidence: 99%

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Formoterol Turbuhaler as reliever medication in patients with acute asthma

Rubinfeld

Scicchitano²,

Hunt

et al. 2006

European Respiratory Journal

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The aim of this study was to compare the efficacy and safety of formoterol versus salbutamol as reliever medication in patients presenting at an emergency dept with acute asthma.A randomised, double-blind, double-dummy, parallel group study was performed in four Australian emergency treatment centres. The study included a total of 78 adult patients (mean baseline forced expiratory volume in one second (FEV1) 1.83 L; 59% predicted) with acute asthma. Based on the expected dose equivalence of formoterol Turbuhaler1 4.5 mg (delivered dose) and salbutamol pressurised metered-dose inhaler 200 mg (metered dose), patients received a total of formoterol Turbuhaler1 36 mg (delivered) or salbutamol pressurised metered-dose inhaler with spacer 1,600 mg (metered), divided into two equal doses at 0 and 30 min. FEV1, peak expiratory flow and systemic b 2 -agonist effects were monitored for 4 h. The primary variable was FEV1 % pred at 45 min.At 45 min, mean increases in FEV1 expressed in % pred were 6.6% and 9.3%, respectively, with a small adjusted mean difference in favour of salbutamol (3.0%, 95% confidence interval -2.0-8.0). Transient increases in systemic b 2 -agonist effects occurred predominantly with salbutamol, although no significant treatment differences were observed. Eight patients discontinued due to adverse events.In this study of patients presenting at emergency depts with acute asthma, formoterol Turbuhaler1 36 mg was well tolerated and, as rescue therapy, had an efficacy that was not different from that of salbutamol pressurised metered-dose inhaler with spacer 1,600 mg in the number of patients studied.

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Section: Discussionmentioning

confidence: 99%

“…Indeed, in one cumulative-dose study, comparing formoterol Turbuhaler1 with terbutaline Turbuhaler1 in acute asthma, 20 as-needed doses of formoterol up to a maximum of 90 mg were safely administered, with improved tolerability compared with 20 as-needed doses of terbutaline (total dose 10 mg) [20].…”

Section: Discussionmentioning

confidence: 99%

Formoterol Turbuhaler as reliever medication in patients with acute asthma

Rubinfeld

Scicchitano²,

Hunt

et al. 2006

European Respiratory Journal

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“…for 6 weeks) significantly reduced the number of neutrophils in bronchial biopsies [28]. Lastly, formoterol has been also shown to be as effective, safe and well tolerated as terbutaline, in patients with acute bronchoconstriction caused by asthma and chronic obstructive pulmonary disease [29].…”

Section: Discussionmentioning

confidence: 99%

Formoterol protects against platelet-activating factor-induced effects in asthma

Gabrijelcic

Casas²,

Rabinovich

et al. 2004

European Respiratory Journal

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Platelet-activating factor (PAF) is an inflammatory mediator that provokes neutropaenia, bronchoconstriction and gas exchange defects due to exudation of bulk plasma within the airways. While the inhibitory effects of short-acting b 2 -agonists on PAF-induced disturbances have been consistently shown, those of longacting b 2 -agonists are less convincing.To further explore the mechanisms involved in PAF challenge in asthma, 12 patients (forced expiratory volume in one second, 90¡4% predicted) were investigated 2 h after inhaled formoterol (18 mg), in a double-blind, placebo-controlled, crossover design following PAF (18 mg) inhalation.Compared with the placebo, at 5 min, premedication with formoterol reduced PAFinduced cough and dyspnoea, and attenuated increased respiratory system resistance (by 67%) and arterial deoxygenation (by 50%). Likewise, ventilation-perfusion (V9A/Q9) inequality improved, as reflected by the dispersion of pulmonary blood flow (by 63%) and an overall index of V9A/Q9 heterogeneity (by 71%). In contrast, PAF-induced facial flushing, neutropaenia and subsequent rebound neutrophilia remained unchanged.The improvement in gas exchange abnormalities shown after platelet-activating factor in patients with asthma pretreated with formoterol at the recommended clinical dose may reflect, in addition to its class effects, an anti-exudative effect of formoterol in the airways. Eur Respir J 2004; 23: 71-75.

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“…Formoterol is a potent LABA with a rapid onset of bronchodilatation [6,7] and a relatively fast clinical response when added as regular medication for patients who are symptomatic on ICS alone [5,8,9]. The question therefore arises, could formoterol with its rapid onset of action, also be used safely and effectively as reliever medication for asthma [10]? Are there risks of tolerance associated with regular use of formoterol that could reduce its benefit when used as a reliever for acute symptoms [11]?…”

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confidence: 99%

“…In view of the high likelihood of this, formoterol should be shown to be at least as safe and effective during exacerbations as SABA, the current treatment for acute symptoms during exacerbations [10,18]. The possibility that formoterol could be used in exacerbations both to relieve increasing asthma symptoms and to achieve more rapid control of deteriorating asthma is suggested by the relatively fast response when LABA are added as regular medication for patients who are symptomatic on ICS alone [5][6][7][8].…”

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confidence: 99%

Formoterol as relief medication in asthma: the jury is still out

Jenkins¹

2003

Eur Respir J

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Despite concerns that use of long-acting b-agonists (LABA) could be associated with risk of worsening asthma, to date these drugs have proven safe and highly effective [1,2]. Early studies demonstrated no increase in asthma exacerbations when added to inhaled corticosteroids (ICS) as long-term maintenance medication and subsequent studies have shown significantly reduced risks of exacerbations and improved, more rapid establishment of asthma control compared to adding more ICS [3][4][5]. Formoterol is a potent LABA with a rapid onset of bronchodilatation [6,7] and a relatively fast clinical response when added as regular medication for patients who are symptomatic on ICS alone [5,8,9]. The question therefore arises, could formoterol with its rapid onset of action, also be used safely and effectively as reliever medication for asthma [10]? Are there risks of tolerance associated with regular use of formoterol that could reduce its benefit when used as a reliever for acute symptoms [11]? Are there other risks, associated with its adrenergic and metabolic effects, that could be increased by its use when added to regular formoterol, resulting in worse outcomes [12]?Some of these questions have already been addressed in two 12 week randomised controlled trials. TATTERSFIELD et al. [13] showed in a double-blind study in 362 symptomatic patients taking ICS (mean daily dose 870 mg) that formoterol 4.5 mg as reliever medication was associated with fewer asthma exacerbations and a longer time to first exacerbation compared to terbutaline 500 mg. Serum potassium and electrocardiogram variables were monitored at clinic visits and no differences between treatments were shown. The relative risk ratio for an exacerbation requiring oral corticosteroids was 0.55 (95% confidence interval 0.34-0.89). The average daily dose of formoterol was four puffs of 4.5 mg, and this did not change over the period of the study. In a double-blind randomised controlled trial in 357 symptomatic patients with moderate asthma taking ICS and regular formoterol 9 mg b.i.d., IND et al. [14] compared the addition of formoterol 4.5 mg or terbutaline 500 mg as needed over 12 weeks. Adverse events, electrocardiograms and serum potassium were monitored. Both treatments were equally safe and there was no significant difference in severe exacerbation rates between treatment groups. On average patients used 2 puffs of formoterol 4.5 mg as reliever medication daily, and 20% patients had an exacerbation requiring oral steroids, with no significant differences between treatments. These authors concluded that formoterol could replace short-acting b-agonists (SABA) as reliever medication, and that the concept merited testing in a "real-world" setting. More recently, some concern has been raised from preliminary reports about the risk of exacerbation with regular LABA in particular subgroups of patients [15] or at high doses [16], although more information from these studies is needed.The safety of formoterol as a reliever has now been further addressed by one of ...

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Safety of formoterol Turbuhaler(R) at cumulative dose of 90 g in patients with acute bronchial obstruction

Cited by 70 publications

References 18 publications

Formoterol Turbuhaler as reliever medication in patients with acute asthma

Formoterol Turbuhaler as reliever medication in patients with acute asthma

Formoterol protects against platelet-activating factor-induced effects in asthma

Formoterol as relief medication in asthma: the jury is still out

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