Efficacy assessments
The primary outcome measure was the effect of NVA237 50 μg
on exercise tolerance versus placebo after 3 weeks of treatment
(Day 21). Days 1 and 21, one hour after drug administration,
exercise tolerance was measured by exercise endurance time
during a SMET. Submaximal exercise testing was performed
as described by the European Respiratory Society (ERS) Task
Force on Standardization of Clinical Exercise Testing20 at 80%
of maximum work capacity evaluated at screening (during the
incremental cycle endurance test). Briefly, 3 minutes of rest on
the bicycle was followed by 1 minute of unloaded pedaling.
Patients then pedaled at 80% of Wmax until exhaustion, and
finally pedaled unloaded for $2 minutes (recovery period).
Exercise endurance was time from the commencement of
loaded pedaling to stopping the exercise.
Spirometrically measured IC at isotime (measurements
were taken within the final 30 seconds of each 2-minute