For the pre-specified primary endpoint of 0-24 hour weighted mean forced expiratory volume in one second (FEV1), FF/VI 100/25mcg demonstrated a statistically significant improvement in lung function compared with FF 100mcg (108ml, 95% CI 45, 171 p < 0.001) at the end of the 12 week treatment period. In patients receiving FF/VI 200/25mcg an additional improvement of 24ml (95% CI -37, 86) was observed when compared with FF/VI 100/25mcg.
While FF/VI is approved in the US for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) and to reduce exacerbations of COPD in patients with a history of exacerbations, FF/VI is not an
These results will inform GSK's discussions with the
The most common reported side effects across all treatment arms included headache, nasopharyngitis, upper respiratory tract infection and influenza. The incidences of any on-treatment serious adverse events across all treatment arms were similar (FF 100mcg < 1%, FF/VI 100/25mcg 1%, FF/VI 200/25mcg < 1%).
"There is an ongoing unmet medical need among patients with asthma," said Rick E Winningham, Chief Executive Officer of
About the study design
The study is a 12 week, double-blind, parallel group, multicentre study to assess the efficacy and safety of FF/VI 200/25mcg inhalation powder, FF/VI 100/25mcg inhalation powder and FF 100mcg inhalation powder, evaluating 990 patients with moderate to severe persistent asthma. Patients were randomised to one of the three treatments taken once-daily in the evening. The primary endpoint was weighted mean serial FEV1 at the end of the 12 week treatment period. The primary comparison was FF/VI 100/25mcg versus FF 100mcg.
This medicine comprises the ICS fluticasone furoate (FF) and the long-acting beta2 agonist (LABA) vilanterol (VI), as FF/VI and is administered via a dry powder inhaler (DPI) called Ellipta®.
FF/VI 100/25mcg was approved in
Breo Ellipta is not approved or licensed in the US for the relief of acute bronchospasm or the treatment of asthma. For full US prescribing information, including BOXED WARNING and Medication Guide please visit us.gsk.com or US Prescribing Information Breo Ellipta.
Other FF/VI Regulatory Activity
FF/VI 100/25 mcg was approved for the treatment of COPD by
Asthma: the regular treatment of asthma in adults and adolescents aged 12 years and older where use of a combination medicinal product (long-acting beta2-agonist and inhaled corticosteroid) is appropriate:
- patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short-acting beta2-agonists
COPD: the symptomatic treatment of adults with chronic obstructive pulmonary disease (COPD) with a FEV1 < 70% predicted normal (post-bronchodilator) with an exacerbation history despite regular bronchodilator therapy.
FF/VI is not approved or licensed anywhere outside of the US,
Relvar®, Breo® and Ellipta® are trademarks of the GlaxoSmithKline group of companies. The use of the brand name Relvar is not approved by any regulatory authorities outside of
Important Safety Information (ISI)
The following ISI is based on the Highlights section of the U.S. Prescribing Information for Breo Ellipta for the maintenance treatment of airflow obstruction in patients with COPD and to reduce exacerbations of COPD in patients with a history of exacerbations. Please consult the full Prescribing Information for all the labeled safety information for Breo Ellipta.
Long-acting beta2-adrenergic agonists (LABAs), such as vilanterol, one of the active ingredients in Breo Ellipta, increase the risk of asthma-related death. A placebo-controlled trial with another
Breo Ellipta is contraindicated in patients with severe hypersensitivity to milk proteins or who have demonstrated hypersensitivity to either fluticasone furoate, vilanterol, or any of the excipients.
Breo Ellipta should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of COPD, or as rescue therapy for the treatment of acute episodes of bronchospasm. Acute symptoms should be treated with an inhaled, short-acting beta2-agonist.
Breo Ellipta should not be used more often than recommended, at higher doses than recommended, or in conjunction with other medications containing LABAs, as an overdose may result.
Oropharyngeal candidiasis has occurred in patients treated with Breo Ellipta. Patients should rinse their mouth with water without swallowing after inhalation to help reduce this risk.
An increase in the incidence of pneumonia has been observed in subjects with COPD receiving the fluticasone furoate/vilanterol combination, including Breo Ellipta100 mcg/25 mcg, in clinical trials. There was also an increased incidence of pneumonias resulting in hospitalization. In some incidences these pneumonia events were fatal.
Patients who use corticosteroids are at risk for potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. A more serious or even fatal course of chickenpox or measles may occur in susceptible patients.
Particular care is needed for patients who have been transferred from systemically active corticosteroids to inhaled corticosteroids because deaths due to adrenal insufficiency have occurred in patients with asthma during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids.
Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage of inhaled corticosteroids in susceptible individuals.
Caution should be exercised when considering the coadministration of Breo Ellipta with long‐term ketoconazole and other known strong CYP3A4 inhibitors because increased systemic corticosteroid and cardiovascular adverse effects may occur.
As with other inhaled medicines, Breo Ellipta can produce paradoxical bronchospasm which may be life-threatening. Vilanterol, the
Breo Ellipta should be used with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, ketoacidosis, and in patients who are unusually responsive to sympathomimetic amines.
Beta-adrenergic agonist medicines may produce significant hypokalemia in some patients. Beta-adrenergic agonist medicines may produce transient hyperglycemia in some patients.
The most common adverse reactions ( ≥ 3% and more common than in placebo) reported in two 6-month clinical trials with Breo Ellipta (and placebo) were nasopharyngitis, 9% (8%); upper respiratory tract infection, 7% (3%); headache, 7% (5%); and oral candidiasis, 5% (2%). In addition to the events reported in the 6-month studies, adverse reactions occurring in ≥ 3% of the subjects treated with Breo Ellipta in two 1-year studies included COPD, back pain, pneumonia, bronchitis, sinusitis, cough, oropharyngeal pain, arthralgia, hypertension, influenza, pharyngitis, diarrhea, peripheral edema, and pyrexia.
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