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

NCT ID: NCT03181880

Last Updated: 2017-07-02

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-04
• Study Completion Date: 2018-12-03

Brief 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.

Detailed 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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Aclidinium/formoterol

Patients will be randomized to receive either Aclidinium bromide/formoterol fumarate fixed-dose combination

Group Type: ACTIVE_COMPARATOR

Aclidinium bromide/formoterol fumarate combination

Intervention Type: DRUG

Patients will be randomized to receive either Aclidinium bromide/formoterol fumarate fixed-dose combination (Duaklir™ Genuair®), or Standard Of Care (SOC) Bronchodilators.

The product in study is Aclidinium bromide/formoterol fumarate fixed-dose combination (Duaklir™ Genuair®).

Each inhaler will contain at least 60 doses (and a maximum of 68 doses) of aclidinium bromide/formoterol fixed-dose combination 400μg /12μg. Patients will be instructed to take 1 puff in the morning (09:00 ± 1 h) and 1 puff in the evening (21:00 ± 1 h) during the 12 weeks of treatment.

Bronchodilators

The comparator arm consists of SOC.

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: DRUG

Brochodilators

Interventions

Aclidinium bromide/formoterol fumarate combination

Patients will be randomized to receive either Aclidinium bromide/formoterol fumarate fixed-dose combination (Duaklir™ Genuair®), or Standard Of Care (SOC) Bronchodilators.

The product in study is Aclidinium bromide/formoterol fumarate fixed-dose combination (Duaklir™ Genuair®).

Each inhaler will contain at least 60 doses (and a maximum of 68 doses) of aclidinium bromide/formoterol fixed-dose combination 400μg /12μg. Patients will be instructed to take 1 puff in the morning (09:00 ± 1 h) and 1 puff in the evening (21:00 ± 1 h) during the 12 weeks of treatment.

Intervention Type: DRUG

Standard of Care

Brochodilators

Intervention Type: DRUG

Other Intervention Names

Duaklir™ Genuair®

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

-

• 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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

QuintilesIMS, Inc.

UNKNOWN

Sponsor Role: collaborator

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anna Ribera

Role: STUDY_DIRECTOR

AstraZeneca

Other Identifiers

D6570R00004

Identifier Type: -

Identifier Source: org_study_id