The Transition Dyspnea Index (TDI) and the St. George’s Respiratory Questionnaire (SGRQ) wereas also included in the replicate, placebo- and active-controlled, 48-week trials [Trials 1 and 2].
After 24 weeks, there was no significant difference between Striverdi Respimat, formoterol and placebo in the TDI focal score, due to an unexpected improvement in the placebo group in one study (Table 1); in a post-hoc analysis that accounted for patient discontinuations, the difference between Striverdi Respimat and placebo was significant.