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Efficacy and safety of Incruse Ellipta when added to Relvar Ellipta in patients with COPD


Results from two phase III studies were presented. They have shown that patients with chronic obstructive pulmonary disease ( COPD ) who received the anticholinergic, Incruse Ellipta ( Umeclidinium 62.5 mcg ), or Umeclidinium 125mcg ( an unlicensed dose ) in addition to Relvar / Breo Ellipta ( Fluticasone furoate / Vilanterol, FF/VI ), an inhaled corticosteroid / long-acting beta2-agonist combination, achieved an additional improvement in lung function ( FEV1 ) compared to patients receiving Fluticasone furoate / Vilanterol plus placebo.
The studies showed that for the primary endpoint of trough FEV1 at day 85, the addition of Umeclidinium 62.5 mcg or Umeclidinium 125 mcg to FF/VI 100/25 mcg resulted in a statistically significant improvement in lung function when compared with FF/VI 100/25 mcg plus placebo in patients with COPD.

Both studies ( 200109 and 200110 ) were 12-week multicentre, randomised, double-blind placebo-controlled studies. 1238 patients with an established clinical history of COPD and an FEV1 of less than or equal to 70%, were randomised and treated in the studies.
Eligible patients were randomised 1:1:1 to receive Umeclidinium 62.5 mcg, Umeclidinium 125mcg or placebo added to open-label FF/VI 100/25mcg.
All treatments were administered once daily in the dry powder inhaler ( DPI ), Ellipta.
The primary endpoint for both studies was trough forced expiratory volume in one second ( FEV1 ) on day 85.

Incruse Ellipta is an anticholinergic ( also known as a long-acting muscarinic antagonist or LAMA ) approved for the long-term once-daily maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema. Incruse contains 62.5 mcg Umeclidinium delivered by the Ellipta inhaler.

200109 trial

For the pre-specified primary endpoint of trough FEV1 ( day 85 ), compared with placebo added to FF/VI 100/25 mcg, both Umeclidinium 62.5 mcg and Umeclidinium 125 mcg added to FF/VI 100/25 mcg, produced statistically significant improvements ( Umeclidinium 62.5 mcg plus FF/VI 100/25 mcg: 124 mL difference versus placebo plus FF/VI 100/25 mcg; Umeclidinium 125 mcg plus FF/VI 100/25 mcg: 128 mL difference versus placebo plus FF/VI 100/25 mcg, both p less than 0.001 ).

Incidence of on-treatment adverse events were 36% Umeclidinium 62.5 mcg + FF/VI 100/25 mcg, 39% Umeclidinium 125 mcg + FF/VI 100/25 mcg, 35% placebo + FF/VI 100/25 mcg.
The most frequently reported adverse events ( greater than or equal to 3% in any treatment group ) were headache, nasopharyngitis, back pain, dysgeusia ( an abnormal taste or change in taste ), cough, diarrhoea and influenza.

The incidence of any cardiovascular adverse events of special interest was 2% Umeclidinium 62.5 mcg + FF/VI 100/25 mcg, 1% Umeclidinium 125 mcg + FF/VI 100/25 mcg, 3% placebo + FF/VI 100/25 mcg.

The incidence of pneumonia in the Umeclidinium 125 mcg + FF/VI 100/25 mcg and the placebo + FF/VI 100/25 mcg groups was 1%. There were no reported cases of pneumonia in the Umeclidinium 62.5 mcg + FF/VI 100/25 mcg group.

One death was reported in the placebo + FF/VI 100/25 mcg group and was deemed non drug related by the investigator. There were no deaths reported in the Umeclidinium + FF/VI 100/25 mcg treatment groups.

200110 trial

For the pre-specified primary endpoint of trough FEV1 ( day 85 ), compared with placebo added to FF/VI 100/25 mcg, Umeclidinium 62.5 mcg and Umeclidinium 125 mcg added to FF/VI 100/25 mcg, produced statistically significant improvements ( Umeclidinium 62.5 mcg plus FF/VI 100/25 mcg: 122mL difference versus placebo plus FF/VI 100/25 mcg; Umeclidinium 125 mcg plus FF/VI 100/25 mcg: 111mL difference versus placebo plus FF/VI 100/25 mcg, both p less than 0.001).

Incidence of on-treatment adverse events were 33% Umeclidinium 62.5 mcg + FF/VI 100/25 mcg, 30% Umeclidinium 125 mcg + FF/VI 100/25 mcg, 39% placebo + FF/VI 100/25 mcg.
The most frequently reported adverse events ( greater than or equal to 3% in any treatment group ) were nasopharyngitis, headache and back pain.

The incidence of any cardiovascular adverse events of special interest was similar across treatment groups ( less than 1% Umeclidinium 62.5 mcg + FF/VI 100/25 mcg, 1% Umeclidinium 125 mcg + FF/VI 100/25 mcg, 3% placebo + FF/VI 100/25 mcg ).

The incidence of pneumonia was the same ( less than 1% ) in all treatment groups.

Four deaths were reported in the placebo + FF/VI 100/25 mcg group and one death was reported in the Umeclidinium 62.5 mcg + FF/VI 100/25 mcg treatment group. All deaths were deemed non-drug related by the investigator. ( Xagena )

Source: GSK; 2014

XagenaMedicine_2014



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