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

NCT03181880 | Withdrawn Phase 4

• 1 other identifier: D6570R00004
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

ASTUTE; Chronic Obstructive Pulmonary Disease; Randomised; Pragmatic; Standard of Care; Aclidinium bromide/formoterol fumarate fixed-dose combination; Duaklir; Genuair

Outcome Measures

Primary Outcomes (2)

• Change from baseline in overall early morning COPD symptom severity score of aclidinium bromide/formoterol fumarate dihydrate inhalation powder vs. Standard of Care bronchodilators as measured by the Early Morning Symptoms of COPD Instrument over 12 wks.

  Changes from baseline compared between aclidinium bromide/formoterol fumarate dihydrate inhalation powder and Standard of Care bronchodilators. Baseline values for EMSCI will be averaged over the study entry and previous day. For longitudinal analyses, each daily measure will be aggregated on a weekly (7 days) basis during the weeks of measurement (weeks 4, 8, and/or 12) by taking the mean value of all available measurements during the week.

  study entry and previous day (retrospectively), days 22-28, days 50-56, days 78-84

• Change from baseline in overall night time COPD symptom severity score of aclidinium bromide/formoterol fumarate dihydrate inhalation powder vs. Standard of Care bronchodilators as measured by the Nighttime Symptoms of COPD Instrument over 12 weeks.

  Changes from baseline compared between aclidinium bromide/formoterol fumarate dihydrate inhalation powder and Standard of Care bronchodilators. Baseline values for NiSCI will be averaged over the study entry and previous day. For longitudinal analyses, each daily measure will be aggregated on a weekly (7 days) basis during the weeks of measurement (weeks 4, 8, and/or 12) by taking the mean value of all available measurements during the week.

  study entry and previous day (retrospectively), days 22-28, days 50-56, days 78-84

Secondary Outcomes (5)

• Change from baseline in daily RS total Score of aclidinium bromide/formoterol fumarate dihydrate inhalation powder versus Standard of Care bronchodilators measured by the E-RS™COPD scale over 12 weeks.

  study entry and previous day (retrospectively), days 22-28, days 50-56, days 78-84

• Change from baseline in health status of aclidinium bromide/formoterol fumarate dihydrate inhalation powder versus Standard of Care bronchodilatorsmeasured by the COPD assessment Test (CAT) over 12 weeks.

  study entry, days 28, 56 and 84

• Change from baseline in total time index of aclidinium bromide/formoterol fumarate dihydrate inhalation powder versus Standard of Care bronchodilators measured by the Yale Physical Activity Survey (YPAS) over 12 weeks.

  study entry, days 28, 56 and 84

• Change from baseline in Energy Expenditure Index of aclidinium bromide/formoterol fumarate dihydrate inhalation powder versus Standard of Care bronchodilators measured by the Yale Physical Activity Survey (YPAS) over 12 weeks.

  study entry, days 28, 56 and 84

• Change from baseline in Activity Dimensions Summary Index of aclidinium bromide/formoterol fumarate dihydrate inhalation powder versus Standard of Care bronchodilators measured by the Yale Physical Activity Survey (YPAS) over 12 weeks.

  study entry, days 28, 56 and 84

Study Arms (2)

Aclidinium/formoterol

ACTIVE COMPARATOR

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

Drug: Aclidinium bromide/formoterol fumarate combination

Bronchodilators

ACTIVE COMPARATOR

The comparator arm consists of SOC.

Drug: Standard of Care

Interventions

Aclidinium bromide/formoterol fumarate combination 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.

Also known as: Duaklir™ Genuair®

Aclidinium/formoterol

Standard of Care DRUG

Brochodilators

Bronchodilators

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead
• QuintilesIMS, Inc.: collaborator

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

aclidinium bromide; Standard of Care

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Anna Ribera

  AstraZeneca

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2017
• First Posted: June 9, 2017
• Study Start: December 4, 2017
• Primary Completion: December 3, 2018
• Study Completion: December 3, 2018
• Last Updated: July 2, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share