Defining a COPD composite safety endpoint for demonstrating efficacy in clinical trials: results from the randomized, placebo-controlled UPLIFT® trial

[1] Calverley PM(2007)Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease N Engl J Med 356 775-89

[2] Anderson JA(2008)A 4-year trial of tiotropium in chronic obstructive pulmonary disease N Engl J Med 359 1543-54

[3] Celli B(2013)The Tiotropium Safety and Performance in Respimat Trial (TIOSPIR), a large scale, randomized, controlled, parallel-group trial-design and rationale Respir Res 14 40-22

[4] Ferguson GT(2013)The Study to Understand Mortality and Morbidity in COPD (SUMMIT) study protocol Eur Respir J 41 1017-8

[5] Jenkins C(2014)Informed choice of composite end points in cardiovascular trials Circ Cardiovasc Qual Outcomes 7 170-62

[6] Jones PW(2015)Impact of renal failure on all-cause mortality and other outcomes in patients treated by percutaneous coronary intervention Arch Cardiovasc Dis 108 554-9

[7] Tashkin DP(2012)A pivotal registration phase III, multicenter, randomized tuberculosis controlled trial: design issues and lessons learnt from the gatifloxacin for TB (OFLOTUB) project Trials 13 61-82

[8] Celli B(2014)Composite endpoints in trials of type-2 diabetes Diabetes Obes Metab 16 492-06

[9] Senn S(1999)Development of a multiple sclerosis functional composite as a clinical trial outcome measure Brain 122 871-e20

[10] Burkhart D(2015)Final results of a self-apposing paclitaxel-eluting stent fOr the PErcutaNeous treatment of de novo lesions in native bifurcated coronary arteries study EuroIntervention 11 20141127-9

[1] Calverley PM(2007)Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease N Engl J Med 356 775-89

[2] Anderson JA(2008)A 4-year trial of tiotropium in chronic obstructive pulmonary disease N Engl J Med 359 1543-54

[3] Celli B(2013)The Tiotropium Safety and Performance in Respimat Trial (TIOSPIR), a large scale, randomized, controlled, parallel-group trial-design and rationale Respir Res 14 40-22

[4] Ferguson GT(2013)The Study to Understand Mortality and Morbidity in COPD (SUMMIT) study protocol Eur Respir J 41 1017-8

[5] Jenkins C(2014)Informed choice of composite end points in cardiovascular trials Circ Cardiovasc Qual Outcomes 7 170-62

[6] Jones PW(2015)Impact of renal failure on all-cause mortality and other outcomes in patients treated by percutaneous coronary intervention Arch Cardiovasc Dis 108 554-9

[7] Tashkin DP(2012)A pivotal registration phase III, multicenter, randomized tuberculosis controlled trial: design issues and lessons learnt from the gatifloxacin for TB (OFLOTUB) project Trials 13 61-82

[8] Celli B(2014)Composite endpoints in trials of type-2 diabetes Diabetes Obes Metab 16 492-06

[9] Senn S(1999)Development of a multiple sclerosis functional composite as a clinical trial outcome measure Brain 122 871-e20

[10] Burkhart D(2015)Final results of a self-apposing paclitaxel-eluting stent fOr the PErcutaNeous treatment of de novo lesions in native bifurcated coronary arteries study EuroIntervention 11 20141127-9