GlaxoSmithKline plc (GSK) has published results from the AUSTRI (SAS115359) study designed to evaluate the safety profile of the combinatory therapy Advair® Diskus® in patients with asthma, and which showed non-inferiority against a monotherapy in the trial. The large-scale safety study was launched as part of a post-marketing requirement of GSK mandated by the US Food and Drug Administration (FDA).
Asthma is a chronic inflammatory disease caused by a mix of genetic and environmental factors such as pollutants, dust and cigarette smoking. Mucus build-up in airways of patients with asthma results in symptoms that include difficulties in breathing, coughing, chest tightness, and frequent respiratory infections.
Asthma, a chronic inflammatory disease, has no cure, but symptoms can be relieved through the prescription of various monotherapy drugs, such as salbutamol and oral corticosteroids. When monotherapy treatments fail, combinatory drugs with superior efficacy could help in controlling asthma symptoms. Advair® Diskus® is a combination of the long-acting beta2-adrenergic agonists (LABA), salmeterol, and the inhaled corticosteroid (ICS) fluticasone propionate (FP). However, active ingredients based on LABA, such as salmeterol, are known to increase risk of asthma-related hospitalization and death.
The primary goal of the AUSTRI study was to evaluate the safety profile of Advair® Diskus® with FP monotherapy in terms of serious events related to death, intubations and hospitalizations in adolescents (12–17 years of age) and adults (18 years and older) with asthma, and figure out if the addition of LABA to ICS therapy (FSC) compares well with ICS therapy alone (FP).
A total of 11,751 patients from 33 countries participated in the trial. The patients were selected based on a history of asthma of at least one year prior to participation, severe asthma exacerbation treated with oral corticosteroids or the equivalent, or hospitalization related to asthma in the year prior to treatment, but not in last 30 days prior to participation. Patients were also screened during the first two weeks of the study, then given 26 weeks of treatment with either FSC or FP. All patients had three scheduled consultations, and in between were contacted by telephone to collect information related to serious side effects. In case of exacerbations, rescue asthma medications like albuterol/salbutamol were allowed.
The results showed that patients treated with FSC twice-daily (100/50mcg, 250/50mcg or 500/50mcg) showed comparable outcomes with corresponding doses of FP twice-daily (100mcg, 250mcg or 500mcg). No asthma-related deaths were recorded in the study, but among participants, 67 patients experienced serious asthma events, of which 34 were treated with FSC and 33 with FP. Also, two asthma intubations were reported with FP-treated patients; the remaining events were mainly hospitalizations.
In summary, researchers found that Advair® Diskus® to have comparable safety features as FP when administrated to adolescent and adult patients with asthma. Details of the results will soon be available through the GSK Clinical Study Register and through future presentations at scientific meetings. Currently, GSK is performing another safety study named VESTRI on children 4–11 years of age and results will be announced during first quarter of 2016.