Study design
We carried out a single center, randomized double-blind, placebo-controlled, double dummy, three-way crossover trial in healthy volunteers comparing the effects of a single dose of lesogaberan 120mg Modified Release (MR), baclofen 40mg and matched placebos on evoked cough responses to capsaicin (Figure1; Study overview). Participants were dosed with either lesogaberan plus baclofen placebo, lesogaberan placebo plus baclofen or lesogaberan placebo plus baclofen placebo. Capsaicin cough challenge was performed at screening and then repeated on each study day at 2h post dosing which was the peak serum concertation (Cmax) for both therapies. The washout period between doses was ≥7 days.