Safety of formoterol by Turbuhaler(R) as reliever medication compared with terbutaline in moderate asthma

Abstract

The present study compared the safety of 4.5 mg formoterol with 0.5 mg terbutaline, both by Turbuhaler1 and used as needed, in addition to regular formoterol in moderate asthma.In this double-blind parallel-group study, 357 patients taking a moderate-to-high dose of inhaled corticosteroids and additional terbutaline (2-5 inhalations?day -1 during run-in) were randomised to either formoterol or terbutaline as needed in addition to formoterol 9 mg b.i.d. over 12 weeks. Adverse events, serum potassium levels, electrocardiogram, vital signs and lung function were assessed monthly; peak expiratory flow and severe asthma exacerbations were recorded daily.Patients used 2.16 (range 0.0-6.3) formoterol and 2.34 (range 0.1-7.5) terbutaline relief inhalations?day -1 . No clinically significant differences in safety variables were found between treatments. Statistically greater increases in cardiac frequency (2.6 beats?min -1 , p=0.03) were found on terbutaline. There were 44 and 52 severe asthma exacerbations with formoterol and terbutaline, respectively, with no significant difference in time to first exacerbation. There was also no difference between treatments for other efficacy measures (peak expiratory flow, forced expiratory volume in one second and morning/evening symptom scores).Formoterol 4.5 mg as needed was at least as safe, well tolerated and effective as terbutaline 0.5 mg in stable patients (requiring up to 6 relief inhalations?day -1 ) taking formoterol plus inhaled corticosteroids regularly over 12 weeks. Eur Respir J 2002; 20: 859-866.

Budesonide/formoterol maintenance and reliever therapy: an effective asthma treatment option?

“…The use of as-needed medication was reduced by 38% during the 12-month study with the budesonide/formoterol regimen versus salmeterol/fluticasone plus salbutamol. Previous studies where a short-acting bronchodilator rescue medication, such as salbutamol or terbutaline, was replaced by formoterol in patients receiving combination therapy have reported ,10% reductions in as-needed medication use [26,27]. Thus, the greater reduction in as-needed medication use observed in the present study with the budesonide/formoterol regimen may reflect the improved asthma control provided by as-needed budesonide when used in combination with as-needed formoterol.…”

Global strategy for asthma management and prevention: GINA executive summary

“…Because of the additive effect of this combination, the low dose of glucocorticosteroid is usually sufficient and need only be increased if control is not achieved within 3-4 months with this regimen (Evidence A). The long-acting b 2 -agonist formoterol, which has a rapid onset of action whether given alone [285][286][287][288] or in combination inhaler with budesonide [289,290], has been shown to be as effective as short-acting b 2 -agonist in acute asthma exacerbation. However, its use as monotherapy as a reliever medication is strongly discouraged, since it must always be used in association with an inhaled glucocorticosteroid.…”

Poor adherence with inhaled corticosteroids for asthma: can using a single inhaler containing budesonide and formoterol help?

“…[7][8][9] Because the β 2 -agonist formoterol has a rapid onset and long duration of action, 10 it can be used for symptom relief and maintenance treatment. [11][12][13] When combined with budesonide in a single inhaler and used in this way it simplifies asthma treatment and provides a dose of inhaled corticosteroid with every dose of relief medication. Recent large multicentre studies show that this single-inhaler approach improves asthma control compared with a higher dose of inhaled corticosteroid, [14][15][16] or an equivalent or higher dose of a combined long-acting β 2 -agonist and corticosteroid used for maintenance treatment only.…”