Clinical trial NCT02796677
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Safety Efficacy Aclidinium bromide Formoterol fumarate Tiotropium Bronchodilation COPD
Sponsor: AstraZeneca
Start date: 2016-07-05; Completion date: 2017-06-08
Enrollment: 1595 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multiple dose, randomized, parallel, double-blind, double-dummy, multicenter and multinational Phase III study to determine the efficacy and safety of Aclidinium bromide 400μg/Formoterol Fumarate (AB/FF) 12 μg compared to individual components and TIO (Tiotropium) 18 μg when administered to patients with stable chronic obstructive pulmonary disease (COPD).

Detailed description:
This study was conducted to assess the bronchodilator efficacy and safety as well as effect on health related quality of life of AB/FF 400/12 μg compared to the individual components (AB 400 μg and FF 12 μg) in COPD patients. The trial duration of 24 weeks allows the assessment of the effect on symptoms improvement of the combined treatments versus individual components as well as the long term bronchodilation comparison between AB 400 μg and TIO 18 μg in minimizing the risk of COPD exacerbations in current or former smokers, aged ≥40 in symptomatic COPD patients.

Arms: arm 1: Participants were administered AB/FF 400/12 μg via Pressair®/Genuair® inhaler twice daily for 24 weeks of treatment. arm 2: Participants were administered AB 400 μg via Pressair®/Genuair® inhaler twice daily for 24 weeks of treatment. arm 3: Participants were administered FF 12 μg via Pressair®/Genuair® inhaler twice daily for 24 weeks of treatment. arm 4: Participants were administered TIO 18 μg via Handihaler® inhale once daily for 24 weeks of treatment.
Interventions: intervention 1: Aclidinium bromide 400 μg/Formoterol Fumarate 12 μg (AB/FF 400/12 μg) intervention 2: Aclidinium bromide 400 μg (AB 400 μg) intervention 3: Formoterol fumarate 12 μg (FF 12 μg) intervention 4: Placebo to AB/FF 400/12 μg, AB 400 μg and FF 12 μg intervention 5: Tiotropium 18 μg (TIO 18 μg) intervention 6: Placebo to TIO 18 μg
Intervention descriptions: intervention 1: Inhalation powder intervention 2: Inhalation powder intervention 3: Inhalation powder intervention 4: Inhalation powder intervention 5: Powder in capsules for oral inhalation intervention 6: Powder in capsules for oral inhalation

Protocol documents:
Prot_000.pdf: 
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ϰ͘ϲ͘ϭ
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ϰ͘ϳ
ŶĂůǇƐŝƐŽĨƐĞĐŽŶĚĂƌǇǀĂƌŝĂďůĞƐ͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘Ϯϴ
ϰ͘ϳ͘ϭ
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ϰ͘ϴ
^ĞŶƐŝƚŝǀŝƚǇĂŶĂůǇƐŝƐĨŽƌĐŽͲƉƌŝŵĂƌǇĂŶĚƐĞĐŽŶĚĂƌǇǀĂƌŝĂďůĞƐ͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘Ϯϵ
ϰ͘ϵ
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ϰ͘ϵ͘ϭ
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ϰ͘ϭϬ
ŶĂůǇƐŝƐŽĨĂĚĚŝƚŝŽŶĂůĞĨĨŝĐĂĐǇǀĂƌŝĂďůĞƐ͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘ϯϭ
ϰ͘ϭϬ͘ϭ
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ϰ͘ϭϬ͘Ϯ
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ϰ͘ϭϬ͘ϯ
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ϰ͘ϭϬ͘ϰ
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ϰ͘ϭϬ͘ϱ
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ϰ͘ϭϬ͘ϲ
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ϰ͘ϭϬ͘ϳ
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ϰ͘ϭϭ
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ϰ͘ϭϮ
^ƵďŐƌŽƵƉĂŶĂůǇƐŝƐ͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘ϰϭ
ϰ͘ϭϯ
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ϰ͘ϭϯ͘ϭ
ĚǀĞƌƐĞĞǀĞŶƚƐ;ƐͿ͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘ϰϭ
ϰ͘ϭϯ͘Ϯ
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ϰ͘ϭϯ͘ϯ
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ϰ͘ϭϯ͘ϱ
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ϰ͘ϭϯ͘ϲ
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ϰ͘ϭϯ͘ϳ
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ϰ͘ϭϰ
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ϰ͘ϭϰ͘ϭ
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ϰ͘ϭϰ͘ϭ͘ϭ
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ϰ͘ϭϰ͘ϭ͘Ϯ
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ϰ͘ϭϰ͘ϭ͘ϯ
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ϰ͘ϭϰ͘ϭ͘ϲ
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ϰ͘ϭϰ͘ϭ͘ϳ
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