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Evaluate the Effect of Aclidi...

Evaluate the Effect of Aclidinium Bromide on Long-term Cardiovascular Safety and Exacerbations in Moderate to Very Severe COPD Patients.

NCT ID: NCT01966107

Last Updated: 2018-12-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

3635 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-16

Study Completion Date

2017-09-21

Brief Summary

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The Objectives of this study are to assess the safety of Aclidinium bromide on major adverse cardiovascular events (MACE), to assess the overall safety of Aclidinium bromide and to assess whether Aclidinium bromide reduces moderate or severe COPD exacerbations. This study is a double-blind, randomized, placebo controlled, parallel-group study to evaluate the effect of Aclidinium bromide on the cardiovascular safety and COPD exacerbations in patients with moderate to very severe COPD, as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria.

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Detailed Description

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Conditions

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COPD Chronic Obstructive Pulmonary Disease Moderate to Very Severe COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Aclidinium Bromide

Two-week washout/run-in period \[for patients on a long-acting muscarinic antagonist (LAMA)\] followed by a maximum of 36-month double-blind treatment period.

Group Type EXPERIMENTAL

Aclidinium Bromide

Intervention Type DRUG

400 μg, twice per day, oral administration via a multi-dose dry-powder inhaler (DPI)

Placebo

Two-week washout/run-in period \[for patients on a long-acting muscarinic antagonist (LAMA)\] followed by a maximum of 36-month double-blind treatment period.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Dose matched placebo, twice per day, oral administration via a multi-dose dry-powder inhaler (DPI)

Interventions

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Aclidinium Bromide

400 μg, twice per day, oral administration via a multi-dose dry-powder inhaler (DPI)

Intervention Type DRUG

Placebo

Dose matched placebo, twice per day, oral administration via a multi-dose dry-powder inhaler (DPI)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 1\. Male or female outpatients ≥ 40 years of age
* 2\. Current or former cigarette smokers with a smoking history of at least 10 pack-years
* 3\. A diagnosis of stable, moderate to very severe COPD (GOLD, 2015) with a post-bronchodilator FEV \< 80% FEV1/forced vital capacity (FVC) ratio \< 70%
* 4\. Must have at least one of the following 4 criteria:

1. Documented cerebrovascular disease (stroke or transient ischemic attack, carotid stenosis)
2. Documented coronary artery disease (angina, MI, angioplasty/stent/bypass)
3. Documented peripheral vascular disease or history of claudication
4. At least 2 of the following atherothrombotic risk factors as determined by the PI:

1. Male ≥ 65 years or female ≥ 70 years
2. Diabetes
3. Dyslipidemia
4. Hypertension
5. Waist circumference inches males ≥ 40 in or in females ≥ 38 inches
6. Evidence of renal dysfunction (eGFR \< 60) and microalbuminuria (eGFR is based on modification of diet in renal disease \[MDRD\] equation, microalbuminuria is defined as ≥ 30-300 mcg/mg creatinine on a spot urine or ≥30 mg creatinine on a 24hr urine test)
* 5\. Maintained stable respiratory medications for 2 weeks prior to randomization (Appendix II)
* 6\. Able to perform pulmonary function test (PFT) maneuvers and follow study procedures
* 7\. Women of childbearing potential must have a negative serum β-human chorionic gonadotropin (HCG) pregnancy test at Visit 1A and be practicing medically acceptable method of contraception. Otherwise, female patients should be at least 1 year postmenopausal, surgically sterile (defined as having a hysterectomy or tubal ligation).
* 8\. Should understand study procedures and be willing to participate in the study as indicated by signing the ICF

Exclusion Criteria

* 1\. Significant diseases other than COPD or cardiovascular disease (e.g., metastatic cancer) which, in the opinion of the PI, may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study
* 2\. Unstable or life threatening cardiovascular disease or COPD as determined by the PI
* 3\. Patients with comorbid lung disease such as asthma, cystic fibrosis, bronchiectasis, interstitial lung disease, or pulmonary thromboembolic disease
* 4\. Planned lung transplant or lung volume reduction surgery
* 5\. Currently treated with a combination of LAMA and LABA/ICS therapy.
* 6\. Malignancy for which patient has undergone resection, radiation therapy or chemotherapy within 5 years prior to screening. Patients with treated basal cell and squamous cell (skin) carcinoma are allowed
* 7\. Respiratory infection or COPD exacerbation at Screening and/or within 4 weeks prior to screening
* 8\. Uncontrolled infection resulting from human immunodeficiency virus (HIV) and/or active hepatitis
* 9\. Reported history of drug or alcohol abuse within the past 12 months
* 10\. History of hypersensitivity reaction to inhaled anticholinergics, sympathomimetic amines, or inhaled medication or any component thereof (including report of paradoxical bronchospasm)
* 11\. History of acute urinary retention, treatment refractory benign prostatic hyperplasia (BPH), bladder neck obstruction, or narrow-angle glaucoma (Note: Patients with controlled, stable BPH are not excluded)
* 12\. Patients unable to use a multidose DPI or a pressurized metered-dose inhaler
* 13\. Treatment with any other investigational drug within 30 days (or 6 half-lives, whichever is longer) before Visit 1A
* 14\. Women who are pregnant or breastfeeding
* 15\. Use of any prohibited medication listed in Appendix II
* 16\. Employee or immediate relative of an employee of AstraZeneca, any of its affiliates or partners, or the study center

Minimum Eligible Age

40 Years

Maximum Eligible Age

130 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kenneth R. Chapman, MD MSc FRCPC FACP FCCP

Role: PRINCIPAL_INVESTIGATOR

GSK-CIHR Research Chair in Respiratory Health Care Delivery,

Robert Wise, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Bayview Medical Center, Asthma and Allergy Center

Locations

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Research Site

Birmingham, Alabama, United States

Site Status

Research Site

Birmingham, Alabama, United States

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Birmingham, Alabama, United States

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Birmingham, Alabama, United States

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Birmingham, Alabama, United States

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Florence, Alabama, United States

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Foley, Alabama, United States

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Huntsville, Alabama, United States

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Jasper, Alabama, United States

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Mobile, Alabama, United States

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Tuscaloosa, Alabama, United States

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Chandler, Arizona, United States

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Glendale, Arizona, United States

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Mesa, Arizona, United States

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Peoria, Arizona, United States

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Phoenix, Arizona, United States

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Research Site

Phoenix, Arizona, United States

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Research Site

Phoenix, Arizona, United States

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