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Chronic obstructive pulmonary disease: Umeclidinium improves lung function, dyspnoea and health status compared with placebo


Efficacy and safety of Umeclidinium ( Incruse ) administered in a dry power inhaler were evaluated in moderate-to-very-severe chronic obstructive pulmonary disease patients.
This was a randomised, placebo-controlled study assessing once-daily Umeclidinium 62.5 and 125 mcg over 12 weeks.

The primary end-point was change from baseline in trough forced expiratory volume in 1 s ( FEV1 ) on day 85. Secondary end-points were 0–6 h weighted mean and serial forced expiratory volume in 1 s.
Other end-points were transitional dyspnoea index, health outcomes ( St George’s Respiratory Questionnaire ), pharmacokinetics and safety.

A total of 246 patients was enrolled; 168 completed the study.

On day 85, Umeclidinium 62.5 and 125 mcg significantly improved least squares mean change from baseline in trough FEV1 ( 127 and 152 mL, respectively; p less than 0.001 ) compared with placebo.

On day 84, Umeclidinium 62.5 and 125 mcg significantly improved least squares mean change from baseline in 0–6 h weighted mean ( 166 and 191 mL, respectively; p less than 0.001 ) and serial FEV1 at each time point ( p less than or equal to 0.003 ).

Significant improvement in least squares mean transitional dyspnoea index focal score ( 1.0 and 1.3 units, respectively; p less than or equal to 0.05 ) and change from baseline St George’s Respiratory Questionnaire total score ( -7.9 and -10.87 units, respectively; p less than 0.001 ) were noted compared with placebo at week 12.

The incidence of adverse events was low and similar across treatments.

Umeclidinium 62.5 and 125 mcg has significantly improved lung function, dyspnoea and health status compared with placebo, and were well tolerated in chronic obstructive pulmonary disease patients over 12 weeks. ( Xagena )

Trivedi R et al, ERJ 2014; 43: 72-81

XagenaMedicine_2014



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