to evaluate effectiveness of aclidinium bromide/formoterol fumarate dihydrate in chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease

Summary: astute is a pragmatic open randomised 12-week multinational trial to evaluate the effectiveness of aclidinium bromide/formoterol fumarate dihydrate fixed-dose combination compared to standard of care bronchodilators in chronic obstructive pulmonary disease.

astute is a longitudinal, randomised, multicentre, and multinational pragmatic study of patients with chronic obstructive pulmonary disease to evaluate the comparative effectiveness of aclidinium bromide/formoterol fumarate fixed-dose combination (duaklir™ genuair®) and standard of care bronchodilators in patients treated with long acting bronchodilator monotherapies or patients who abide to the following treatment category: patient is newly diagnosed, or naïve to maintenance therapy, or treated with short-acting bronchodilators as rescue medication, or has not been treated with long-acting bronchodilators in the last 3 months.

Eligibility criteria:
inclusion criteria: patient is aged 40 years or older; * confirmed diagnosis of copd; * spirometry performed at study entry or within the last 3 months preceding study entry with a post-bronchodilator forced expiratory volume in 1 second/forced vital capacity quotient less than 0.7; * patient is a current smoker or an ex-smoker with a smoking history of ≥10 pack-years; * patient belongs to any of these treatment groups: * patient is treated by a monotherapy long-acting bronchodilator (long-acting muscarinic antagonist or long-acting beta agonist), or * naïve copd patient, defined as: * patient is newly diagnosed, or * patient is naïve to maintenance therapy, or * patient is treated with short acting bronchodilators as rescue medication, or * patient has not been treated with long acting bronchodilators in the last 3 months. exclusion criteria: - patients should not be included in the study if any of the following exclusion criteria applies: * patient changed copd treatment regimen over the preceding 3 months; * patient treated or intended to be treated at the time of randomisation with a maintenance regimen of inhaled corticosteroids or inhaled corticosteroids-containing medications; * patient treated or intended to be treated at the time of randomisation with aclidinium bromide/formoterol fumarate dihydrate inhalation powder; * patient had a previous diagnosis of asthma or is suspected of having asthma, asthma-copd overlap or any other chronic respiratory disease other than copd (including severe ones, such as cystic fibrosis, pulmonary fibrosis, active neoplasm except adequately treated \[no evidence of recurrence within 5 years\], active tuberculosis); * patient developed a respiratory tract infection or copd exacerbation within 6 weeks (or 3 months if an exacerbation-related hospitalisation was required) before the randomisation visit; * patient with a history of hypersensitivity reaction to inhaled anticholinergics, sympathomimetic amines, lactose monohydrate, inhaled medication, or any component thereof (including report of paradoxical bronchospasm); * patient has been previously enrolled in the current study. * any condition that in the investigator's opinion, would limit a patient's ability to participate in the study.

Keywords: astute chronic obstructive pulmonary disease randomised pragmatic standard of care aclidinium bromide/formoterol fumarate fixed-dose combination duaklir genuair