QVA149 ( Ultibro Breezhaler ), a novel, once-daily dual bronchodilator containing the long-acting beta2-agonist, Indacaterol and long-acting muscarinic antagonist Glycopyrronium, improves lung function, dyspnea, and health status compared with Tiotropium 18 mcg and Salmeterol / Fluticasone combination ( SFC ) 50/500 mcg, in patients with moderate-to-severe chronic obstructive pulmonary disease ( COPD ).
The purpose of this analysis was to examine the efficacy of QVA149 110/50 mcg in patients with more severe baseline dyspnea ( grade B in GOLD ) compared with Tiotropium or Salmeterol / Fluticasone combination in terms of functional impairment and dyspnea ( Transition Dyspnea Index [ TDI ] ), health status, and lung function at week 26.
The SHINE ( n=2144 ) and ILLUMINATE ( n=523 ) studies randomized patients with moderate-to-severe COPD to placebo, Indacaterol, Glycopyrronium, Tiotropium or QVA149 ( SHINE ); Salmeterol / Fluticasone combination or QVA149 ( ILLUMINATE ) for 26 weeks.
In this analysis, symptomatic patients having a baseline dyspnea index ( BDI ) less than or equal to 7 were selected as a sub-group of patients, representing those with moderate to very severe functional impairment and very severe dyspnea.
In this sub-group of patients, the average BDI score was less than 6.
Previous studies have shown a BDI of 6 is comparable to a modified Medical Research Council ( mMRC ) dyspnea score greater than 2.3,4 TDI, health status ( St George’s Respiratory Questionnaire [ SGRQ ] ), and lung function ( trough and pre-dose forced expiratory volume in 1 second [ FEV1 ] ), at 26 weeks were evaluated.
The baseline mean BDI in each treatment arm were comparable in both SHINE ( Indacaterol: 5.50, Glycopyrronium: 5.44, Tiotropium: 5.57, QVA149: 5.44 ) and ILLUMINATE ( QVA149: 5.78, Salmeterol / Fluticasone combination: 5.85 ) studies.
Improvements in TDI and SGRQ total score, and trough and pre-dose FEV1 were greater for QVA149 versus Tiotropium or Salmeterol / Fluticasone combination at week 26.
Compared with Salmeterol / Fluticasone combination, the improvement in TDI exceeded the minimal clinically important difference of 1.
In conclusion, in a subgroup of symptomatic patients ( with a BDI less than or equal to 7 ) from SHINE and ILLUMINATE population, QVA149 110/50 mcg provided greater improvements in functional impairment, dyspnea, heath status, and lung function in COPD patients with more severe dyspnea ( GOLD grade B ) compared with Tiotropium 18 mcg or Salmeterol / Fluticasone combination 50/500 mcg. ( Xagena )
Source: American Thoracic Society ( ATS ) Meeting, 2014