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

• Status: Withdrawn
• Trial end date: 2018-12-03
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Collaborator: QuintilesIMS, Inc.
• Treatments: Bromides; Formoterol Fumarate

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.