Short-acting beta-agonists are traditionally used to ease symptoms when people experience wheezing and breathlessness during asthma exacerbations. Formoterol is a bronchodilator that works quickly to relieve symptoms and the effect lasts longer. We are interested in whether there are any benefits or disadvantages associated with using formoterol instead of more traditional treatments to relieve symptoms.
We found eight trials involving a total of 22,604 patients. We found that taking formoterol reduced the risk of having an exacerbation that was treated with oral corticosteroids, but none of the other benefits from taking formoterol were statistically significant. Guidelines suggest that long-acting beta-agonists should be given only to patients already taking an inhaled corticosteroid.
We could not find enough trials conducted in children to reach a conclusion on the benefits and harms in children, so we do not recommend using the results to make recommendations on treatment of children with asthma.
In adults, formoterol was similar to short-acting beta2-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 beta2-agonists in some patients. We did not find evidence to recommend changes to guidelines that suggest that long-acting beta2-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.
Formoterol is a long-acting beta2-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 beta2-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We searched the Cochrane Airways Group Specialised Register and websites of clinical trial registers (for unpublished trial data), and we checked the Food and Drug Administration (FDA) submissions in relation to formoterol.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 beta2-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 beta2-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 beta2-agonists.