Despite currently available therapies and detailed guidelines, many people with mild asthma remain symptomatic; it is important to establish the efficacy and safety of new treatments in this group.
A phase III, randomized, double-blind, parallel-group trial evaluated the efficacy and safety of once-daily Tiotropium ( Spiriva ) Respimat 5 mcg or 2.5 mcg versus placebo for 12 weeks in patients with symptomatic asthma on low-dose inhaled corticosteroids ( ICS ) ( 200-400 mcg Budesonide equivalent ).
Primary endpoint: FEV1 peak(0-3h) response ( change from baseline ) at 12 weeks. Secondary endpoints: trough FEV1, FEV1 AUC(0-3h) and PEF ( measured with the AM2+ device ) responses, and ACQ-7 score.
Of 464 treated patients, 155 received Tiotropium 5 mcg, 154 Tiotropium 2.5 mcg, and 155 placebo.
Both Tiotropium doses were superior to placebo in FEV1 peak(0-3h) response ( adjusted mean difference: 5 mcg, 128 mL; 2.5 mcg, 159 mL; both p less than 0.001 ) and trough FEV1 response ( adjusted mean difference: 5 mcg, 122 mL, p=0.001; 2.5 mcg, 110 mL, p=0.003 ).
FEV1 AUC(0-3h) response at each visit, versus placebo, significantly favored Tiotropium 5 mcg ( p=0.009 to p less than 0.001 ) and Tiotropium 2.5 mcg ( all p less than 0.001, except Day 1 ).
Adjusted mean PEFAM and PEFPM responses, versus placebo, each week, all favored Tiotropium 5 mcg ( all p less than 0.001 ) and 2.5 mcg ( all p less than 0.003 ).
Adjusted mean ACQ-7 score was similar across all arms ( 5 mcg, 1.391; 2.5 mcg, 1.438; placebo, 1.377 ).
Adverse events were predominantly mild or moderate and were balanced between treatment groups.
In conclusion, Tiotropium Respimat was effective and well tolerated in patients with symptomatic mild asthma despite low-dose inhaled corticosteroids treatment. ( Xagena )
Paggiaro P et al, AAAAI Meeting, 2014