Using two asthma medications combined in a single inhaler provides superior rescue and preventive treatment than guideline-based treatments among adults whose asthma symptoms are not well controlled, according to two large, randomized clinical trials that were published in The Lancet Respiratory Medicine.
This new therapy is known as SMART (Single Inhaler Maintenance and Reliever Therapy).
The findings in these two studies challenge national (USA) and international asthma guidelines, especially in the United States, where this combined inhaler approach has not yet been approved.
The authors added that the two-medications-in-one inhaler is safe and well tolerated.
As background information, the researchers explained that most adults with asthma do not manage to achieve good control of symptoms, despite effective drug treatment options. A survey of 1,000 asthma patients found that controller drugs are not used by nearly half of all adults and children with persistent asthma.
Medical guidelines advise doctors to prescribe corticosteroids (ICS) plus rapid-onset long-acting β2 agonist (LABA) combination inhaler to achieve control, together with a second short-acting β2 agonist (SABA) inhaler for rescue usage, for the treatment of symptoms.
SMART, on the other hand, uses only a single ICS/LABA inhaler for both relief and preventive treatment.
The first study involved 1,714 adults patients with moderate, persistent asthma from 14 different European countries. The study found that the patients in the SMART beclometasone/formoterol combination had a considerably smaller risk of severe asthma attacks, being hospitalized, or requiring urgent care compared to those receiving current best practice.
The authors said:
“We believe that the additional cost of inhaled corticosteroid and rapid-onset, long-acting β2 agonist combination (29 Eurocents per patient per day) is justifiable because of the significant reduction in severe exacerbations, and specifically hospital admissions, known to have a huge effect on health-care costs in asthma.”
According to previous studies, higher corticosteroid doses, which are linked to considerable side effects, do not improve the symptoms of all asthma patients. LABAs have come under investigation for their association with worsening symptoms of asthma patients, who sometimes have to be hospitalized.
By contrast, the first study of its kind that was not sponsored by the pharmaceutical industry reported that the SMART budesonide/formoterol regimen reduced severe asthma exacerbations risk with no increase in the risk of beta-agonist overuse or increasing long-term corticosteroid exposure.
The New Zealand researchers found that the total number of days of high beta-agonists use, marked overuse and extreme overuse were approximately 40% lower among those in the SMART group compared to the standard treatment group.
They also reported that although the patients in the SMART group had a greater daily exposure to ICS, their overall systemic corticosteroid exposure was similar to that recorded in the standard treatment group. This was because they experienced fewer severe attacks which meant they were exposed to less oral corticosteroid.
René Aalbers from Martini Hospital in the Netherlands, wrote in a Linked Comment in the same journal:
“We now have four options for a patient-tailored strategy of inhaled corticosteroid and a LABA… Despite these options for treatment, we should start with a post-hoc analysis of the substantial patients’ data files from previous controlled trials with SMART and undertake real-life studies, including electronic monitoring because we still do not know which patients will benefit most from which of these four treatment options.”
Written by Christian Nordqvist