To Evaluate Effectiveness of Aclidinium Bromide/Formoterol Fumarate Dihydrate in Chronic Obstructive Pulmonary Disease (ASTUTE)

AstraZeneca

Status and phase

Withdrawn

Phase 4

Conditions

Chronic Obstructive Pulmonary Disease

Treatments

Drug: Aclidinium bromide/formoterol fumarate combination

Drug: Standard of Care

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT03181880

D6570R00004

Details and patient eligibility

About

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.

Full description

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.

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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.