This is a multiple dose, randomised, parallel, double blind, double dummy, multicentre and multinational Phase III study to determine the efficacy and safety of Aclidinium bromide/Formoterol fumarate compared with individual components and placebo and Aclidinium bromide compared with Placebo when administered to patients with stable Chronic Obstructive Pulmonary Disease (COPD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,625
Inhaled Aclidinium bromide/formoterol Fixed-Dose Combination, twice per day via Genuair
Inhaled Aclidinium bromide 400 μg, twice per day via Genuair
Inhaled Formoterol Fumarate 12 μg, twice per day via Turbuhaler
Change From Baseline in 1-hour Morning Post Forced Expiratory Volume in 1 Second (FEV1)
Change from baseline in 1-hour morning post-dose FEV1 of Aclidinium bromide 400 μg/Formoterol fumarate 12 μg compared to Aclidinium bromide at Week 24. Baseline was defined as the average of the two FEV1 values measure prior to the administration of the first dose of the IP at randomisation visit. If one of the two values was missing, the available one was used as baseline. If both values were missing, the screening pre-bronchodilator value was used. Estimand is based on the while on-treatment approach, where treatment estimates are analysed while subjects are taking IP.
Time frame: Week 24, 1-hour morning post-dose
Change From Baseline in Morning Pre-dose (Trough) FEV1 for Aclidinium Bromide/Formoterol Fumarate
Change from baseline in morning pre-dose (trough) FEV1 of Aclidinium bromide 400 μg/Formoterol fumarate 12 μg compared to Formoterol fumarate 12 μg at Week 24. Morning pre-dose (trough) FEV1 was defined as the average of the two FEV1 values at morning pre-dose of IP at Week 24. If one value was missing, the remaining was used as the trough value. Estimand is based on the while on-treatment approach, where treatment estimates are analysed while subjects are taking IP.
Time frame: Week 24, morning pre-dose (trough)
Change From Baseline in Morning Pre-dose (Trough) FEV1 for Aclidinium Bromide
Change from baseline in morning pre-dose (trough) FEV1 of Aclidinium bromide 400 μg compared to placebo at Week 24. Morning pre-dose (trough) FEV1 was defined as the average of the two FEV1 values at morning pre-dose of IP at Week 24. If one value was missing, the remaining was used as the trough value. Estimand is based on the while on-treatment approach, where treatment estimates are analysed while subjects are taking IP.
Time frame: Week 24, morning pre-dose (trough)
Change From Baseline in Peak FEV1
Change from baseline in peak FEV1 of Aclidinium bromide 400 μg compared to placebo at week 24. Peak FEV1 was the highest value recorded at Week 24 after morning IP intake. Estimand is based on the while on-treatment approach, where treatment estimates are analysed while subjects are taking IP.
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Inhaled dose-matched placebo, twice per day via Genuair or via Turbuhaler
Research Site
Baotou, China
Research Site
Beijing, China
Research Site
Beijing, China
Research Site
Beijing, China
Research Site
Beijing, China
Research Site
Cangzhou, China
Research Site
Changchun, China
Research Site
Changsha, China
Research Site
Changsha, China
Research Site
Chengdu, China
...and 64 more locations
Time frame: Week 24, peak
Improvements Transition Dyspnoea Index (TDI) Focal Score
Improvements TDI focal score of Aclidinium bromide 400 μg/Formoterol fumarate 12 μg and Aclidinium bromide 400μg compared to placebo at week 24. Transition Dyspnoea Index (TDI) measures severity of breathlessness in symptomatic patients. An impairment severity score is assigned for three components: functional impairment; magnitude of task and magnitude of effort. Focal scores is derived as the sum of individual component scores. TDI focal score ranges from -9 to +9, with negative values indicating a worsening in dyspnoea, 0 showing no change from baseline and positive values associated with a post-baseline improvement. Estimand is based on the while on-treatment approach, where treatment estimates are analysed while subjects are taking IP.
Time frame: Week 24
Change From Baseline in St Georges Respiratory Questionnaire (SGRQ) Total Score
Change from baseline in SGRQ total score of Aclidinium bromide 400 μg/Formoterol fumarate 12 μg and Aclidinium bromide 400μg compared to placebo at week 24. St. George's Respiratory Questionnaire (SGRQ) measures the impact of COPD on overall health, daily life and perceived well-being. It is composed of 50 items split into 17 parts, from which 3 dimension scores on Symptoms, Activity and Impact are derived. A total score utilising responses to all items can also be derived to assess the overall impact of COPD on quality of life. SGRQ dimension and total scores range from 0 to 100, with higher scores indicating a worse possible health status. Estimand is based on the while on-treatment approach, where treatment estimates are analysed while subjects are taking IP.
Time frame: Week 24