The present study is planned to evaluate the effect of the aclidinium bromide/formoterol fumarate 400/12 μg FDC BID on the hyperinflation, exercise endurance and physical activity in patients with moderate to severe COPD. Additionally, the effect of the behavioural intervention on top of aclidinium bromide/formoterol fumarate 400/12 μg will be assessed both on the exercise endurance and the physical activity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
267
Aclidinium bromide/Formoterol fumarate FDC 400/12μg dry powder for oral inhalation twice daily via Genuair inhaler
Dose-matched placebo dry powder for oral inhalation twice daily via Genuair inhaler
Research Site
Hamilton, Ontario, Canada
Research Site
Kingston, Ontario, Canada
Change From Baseline in Trough Functional Residual Capacity (FRC) After 4 Weeks of Treatment
Baseline values in FRC were defined as the corresponding values just before randomization on Day 1 of treatment (Week 0). Trough values were obtained prior to study drug administration.
Time frame: Baseline and Week 4
Change From Baseline in Endurance Time (ET) During Constant Work Rate Cycle Ergometry at Week 8
The ET was the time from the increase in work rate to 75% Wmax to the point of symptom limitation. Baseline measurements were taken prior to the IP dose on Day 1. Measurements at Week 8 were taken at 3 hours post-dose. Participants underwent a behavioural intervention (consisting of a telecoaching programme to enhance physical activity) between Week 4 and Week 8.
Time frame: Baseline to Week 8
Percentage of Inactive Patients (Mean of <6000 Steps Per Day) at Week 8
Physical activity was assessed by means of measurement of activity parameters (e.g. number of steps) through a Dynaport MoveMonitor and completion of the Daily ProActive Physical Activity in chronic obstructive pulmonary disease (COPD) questionnaire. Compliant criterion based on at least 8 hours per day, and at least 3 days per week. Participants underwent a behavioural intervention (consisting of a telecoaching programme to enhance physical activity) between Week 4 and Week 8. Baseline was defined as mean of steps/day assessed during the week before the randomisation visit.
Time frame: Week 8
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Research Site
Sainte-Foy, Quebec, Canada
Research Site
Saskatoon, Saskatchewan, Canada
Research Site
Berlin, Germany
Research Site
Berlin, Germany
Research Site
Berlin, Germany
Research Site
Berlin, Germany
Research Site
Berlin, Germany
Research Site
Dortmund, Germany
...and 16 more locations