The aim of the present study is to evaluate the effect of aclidinium bromide 400 μg twice a day (BID) administered twice a day versus placebo on exercise endurance and on hyperinflation and dyspnoea at rest and during exercise after 3 weeks of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
112
1 puff of 400 micro grams in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h)
1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h)
Almirall Investigational Site #10
Berlin, Germany
Almirall Investigational Site #6
Berlin, Germany
Almirall Investigational Site #2
Berlin, Germany
Change From Baseline in Endurance Time (Seconds)
Change from baseline in endurance time during constant work rate cycle ergometry to symptom limitation at 75% of Maximum Work load (Wmax) after 3 weeks of treatment.
Time frame: Week 3
Change From Baseline in Trough Inspiratory Capacity (IC) (Litres)
Change from baseline in trough IC after 3 weeks of treatment
Time frame: Week 3
Change From Baseline in Intensity of Dyspnoea
Change from baseline in intensity of dyspnoea based on the Borg CR10 Scale® (ranging from '0'=nothing at all to '10'=extremely strong/maximal dyspnoea, the highest possible numerical value) at isotime during constant work rate cycle ergometry after 3 weeks of treatment.
Time frame: Week 3
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Almirall Investigational Site #4
Frankfurt, Germany
Almirall Investigational Site #5
Großhansdorf, Germany
Almirall Investigational Site #8
Hamburg, Germany
Almirall Investigational Site #9
Hamburg, Germany
Almirall Investigational Site #3
Hanover, Germany
Almirall Investigational Site #7
Lübeck, Germany
Almirall Investigational Site #1
Wiesbaden, Germany
...and 4 more locations