COPDPhase 4ASCENT COPDNCT01966107

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

A Phase 4 study testing Aclidinium Bromide in people with COPD and Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 468 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 40 to 130 years
Conditions the study is for: COPD, Chronic Obstructive Pulmonary Disease, Moderate to Very Severe COPD
What is being tested?: Aclidinium Bromide
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 3,635 participants
Where: 468 sitesin 2 countries
Study dates: 16 Oct 2013to 21 Sep 2017
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 130 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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:
Documented cerebrovascular disease (stroke or transient ischemic attack, carotid stenosis)
Documented coronary artery disease (angina, MI, angioplasty/stent/bypass)

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Documented peripheral vascular disease or history of claudication
At least 2 of the following atherothrombotic risk factors as determined by the PI:
Male ≥ 65 years or female ≥ 70 years
Diabetes
Dyslipidemia
Hypertension
Waist circumference inches males ≥ 40 in or in females ≥ 38 inches
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

Who cannot join

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

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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

Trial locations and contacts

468 sites in 2 countries.

Country

City, postcode or hospital

335 sites in 2 countries

United States300 sites

Research Site
Abingdon, Virginia, 24210
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Akron, Ohio, 44311
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Altoona, Pennsylvania, 16602
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Amarillo, Texas, 79106
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Ames, Iowa, 50010-3014
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Anderson, South Carolina, 29621
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Arlington, Texas, 76014
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Asheville, North Carolina, 28801
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Athens, Tennessee, 37303
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Atlanta, Georgia, 30308
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Atlanta, Georgia, 30310
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Atlanta, Georgia, 30342
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Austin, Texas, 78759
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Avon, Indiana, 46123
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Bakersfield, California, 93301
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Baltimore, Maryland, 21224
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Baltimore, Maryland, 21236
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Baltimore, Maryland, 21237
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Bangor, Maine, 04401
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Bay Pines, Florida, 33744
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Beaumont, Texas, 77702
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Beaver, Pennsylvania, 15009
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Belle Vernon, Pennsylvania, 15012
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Bellevue, Nebraska, 68005
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Bellevue, Washington, 98007
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Bellingham, Washington, 98225
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Belvidere, New Jersey, 07823
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Bensalem, Pennsylvania, 19020
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Biddeford, Maine, 04005
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Bingham Farms, Michigan, 48025
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Birmingham, Alabama, 35209
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Birmingham, Alabama, 35211
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Birmingham, Alabama, 35216
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Birmingham, Alabama, 35233
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Birmingham, Alabama, 35294
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Blue Ridge, Georgia, 30513
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Boerne, Texas, 78006
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Boulder, Colorado, 80304
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Bowling Green, Kentucky, 42101
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Boynton Beach, Florida, 33435
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Brandon, Florida, 33511
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Bridgeton, Missouri, 63044
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Bridgewater, New Jersey, 08807
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Bristol, Connecticut, 06010
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Brooklyn, New York, 11229
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Buckley, Michigan, 49620
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Buffalo, New York, 14215
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Burlington, North Carolina, 27215
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Calabash, North Carolina, 28467
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Canton, Ohio, 44718
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Carnegie, Pennsylvania, 15106
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Caro, Michigan, 48723
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Carrollton, Texas, 75006
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Centennial, Colorado, 80112
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Champaign, Illinois, 61820
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Chandler, Arizona, 85224
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Charleston, South Carolina, 29406
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Charleston, South Carolina, 29407
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Charleston, South Carolina, 29412
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Charleston, West Virginia, 25304
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Charlotte, North Carolina, 28210
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Charlotte, North Carolina, 28262
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Charlotte, North Carolina, 28277
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Chattanooga, Tennessee, 37404
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Chesterfield, Michigan, 48047
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Chesterfield, Missouri, 63017
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Chicago, Illinois, 60611
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Cincinnati, Ohio, 45231
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Clairton, Pennsylvania, 15025
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Clearwater, Florida, 33756
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Clearwater, Florida, 33765
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Colorado Springs, Colorado, 80907
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Colorado Springs, Colorado, 80920
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Columbia, Missouri, 65212
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Columbia, South Carolina, 29204
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Columbus, Georgia, 31904
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Columbus, Ohio, 43207
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Columbus, Ohio, 43215
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Corsicana, Texas, 75110
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Council Bluffs, Iowa, 51503
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Covington, Louisiana, 70433
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Crowley, Louisiana, 70526
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Cypress, Texas, 77429
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Dallas, Texas, 75220
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Dallas, Texas, 75225
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Dallas, Texas, 75235
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Dallas, Texas, 75246
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Dayton, Ohio, 45419
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Dayton, Ohio, 45439
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Dayton, Ohio, 45459
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Daytona Beach, Florida, 32117
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DeBary, Florida, 32713
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DeLand, Florida, 32720
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Delaware, Ohio, 43015
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Dickinson, Texas, 77539
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Doral, Florida, 33122
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Doral, Florida, 33166
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Doral, Florida, 33172
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Downingtown, Pennsylvania, 19335
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Dublin, Ohio, 43016
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Duluth, Georgia, 30096
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Duncanville, Texas, 75116
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Eagle, Idaho, 83616
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Easley, South Carolina, 29640
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East Brunswick, New Jersey, 08816
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East Providence, Rhode Island, 02914
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Elizabeth, New Jersey, 07201
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Elkridge, Maryland, 21075
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Elwood, Indiana, 46036
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Encinitas, California, 92024
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Erie, Pennsylvania, 16508
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Escondido, California, 92025
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Eunice, Louisiana, 70535
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Eustis, Florida, 32726
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Evanston, Illinois, 60201
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Evansville, Indiana, 47714
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Evansville, Indiana, 47715
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Everett, Washington, 98208
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Fall River, Massachusetts, 02720
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Fargo, North Dakota, 58103
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Farmington Hills, Michigan, 48336
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Fayetteville, Tennessee, 37334
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Feasterville-Trevose, Pennsylvania, 19053
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Flint, Michigan, 48504
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Florence, Alabama, 35630
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Foley, Alabama, 36535
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Fort Worth, Texas, 76104
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Fort Worth, Texas, 76107
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Franklin, Tennessee, 37067
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Fremont, Nebraska, 68025
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Fresno, California, 93720
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Gaffney, South Carolina, 29340
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Gaffney, South Carolina, 29341
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Gainesville, Florida, 32653
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Gastonia, North Carolina, 28054
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Georgetown, Texas, 78626
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Gillespie, Illinois, 62033
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Glendale, Arizona, 85306
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Gold River, California, 95670
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Golden, Colorado, 80401
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Grand Island, Nebraska, 68803
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Greensboro, North Carolina, 27405
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Greenville, North Carolina, 27834
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Greenville, South Carolina, 29605
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Greenville, South Carolina, 29615
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Greer, South Carolina, 29651
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Haddon Heights, New Jersey, 08035
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Hayden Lake, Idaho, 83835
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Hendersonville, North Carolina, 28739
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Hendersonville, Tennessee, 37075
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Hialeah, Florida, 33012
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Hialeah, Florida, 33013
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Hialeah, Florida, 33016
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High Point, North Carolina, 27262
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Hodges, South Carolina, 29653
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Hollywood, Florida, 33021
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Hollywood, Florida, 33024
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Homestead, Florida, 33030
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Hopewell Jct, New York, 12533
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Hot Springs, Arkansas, 71913
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Houston, Texas, 77011
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Houston, Texas, 77043
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Houston, Texas, 77058
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Huntersville, North Carolina, 28078
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Huntington Beach, California, 92647
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Huntsville, Alabama, 35801
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Idaho Falls, Idaho, 83404
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Iowa City, Iowa, 52242
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Irving, Texas, 75039
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Jacksonville, Florida, 32209
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Jamaica, New York, 11435
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Jasper, Alabama, 35501
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Jefferson Hills, Pennsylvania, 15025
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Johns Creek, Georgia, 30097
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Jupiter, Florida, 33485
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Kansas City, Missouri, 64128
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Kansas City, Missouri, 64133
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Kettering, Ohio, 45429
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Kissimmee, Florida, 32837
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Kissimmee, Florida, 34741
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Knoxville, Tennessee, 37919
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La Mirada, California, 90638
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Laguna Hills, California, 92653
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Lake Charles, Louisiana, 70601
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Las Vegas, Nevada, 89117
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Las Vegas, Nevada, 89119
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Las Vegas, Nevada, 89123
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Las Vegas, Nevada, 89128
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Lawrenceville, Georgia, 30046
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Leesburg, Florida, 34748
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Lenexa, Kansas, 66219
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Lenoir, North Carolina, 28645
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Levittown, Pennsylvania, 19056
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Lewisburg, West Virginia, 24901
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Lexington, Kentucky, 40503
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Lincoln, California, 95648
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Lincoln, Nebraska, 68510
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Lincoln, Nebraska, 68516
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Little Rock, Arkansas, 72205
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Little Rock, Arkansas, 72209
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Loma Linda, California, 92357
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Los Angeles, California, 90017
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Los Angeles, California, 90048
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Los Angeles, California, 90073
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Louisville, Kentucky, 40202
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Louisville, Kentucky, 40218
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Loxahatchee Groves, Florida, 33470
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Madisonville, Kentucky, 42431
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Maitland, Florida, 32751
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Manassas, Virginia, 20110
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Marietta, Georgia, 30066
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Marshall, Louisiana, 75670
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Maumee, Ohio, 43537
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Melbourne, Florida, 32901
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Melrose Park, Illinois, 60160
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Meridian, Idaho, 83642
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Meridian, Idaho, 83646
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Mesa, Arizona, 85205
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Metairie, Louisiana, 70006
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Methuen, Massachusetts, 01844
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Miami, Florida, 33126
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Miami, Florida, 33133
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Miami, Florida, 33134
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Miami, Florida, 33135
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Miami, Florida, 33142
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Miami, Florida, 33144
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Miami, Florida, 33147
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Miami, Florida, 33165
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Miami, Florida, 33173
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Miami, Florida, 33176
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Miami, Florida, 33183
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Miami, Florida, 33186
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Miami Beach, Florida, 33140
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Michigan City, Indiana, 46360
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Midvale, Utah, 84047
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Minneapolis, Minnesota, 55402
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Missoula, Montana, 59808
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Mobile, Alabama, 36604
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Monroe, North Carolina, 28110
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Monroe, North Carolina, 28112
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Mooresville, North Carolina, 28117
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Morgantown, West Virginia, 26505
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Morton, Illinois, 61550
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Mt. Pleasant, South Carolina, 29464
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Muncie, Indiana, 47303
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Muncie, Indiana, 47304
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Murray, Utah, 84107
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Myrtle Beach, South Carolina, 29588
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Naples, Florida, 34119
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New Bern, North Carolina, 28562
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New Hyde Park, New York, 11040
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New Orleans, Louisiana, 70115
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New Port Richey, Florida, 34653
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New York, New York, 10009
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New York, New York, 10016
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Norcross, Georgia, 30092
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Normal, Illinois, 61761
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Norman, Oklahoma, 73069
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North Chicago, Illinois, 60064
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North Dartmouth, Massachusetts, 02747
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North Hollywood, California, 91606
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North Richland Hills, Texas, 76180
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Northridge, California, 91324
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O'Fallon, Illinois, 62269
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Oakwood, Georgia, 30566
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Ocala, Florida, 34471
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Ocala, Florida, 34474
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Ogden, Utah, 84405
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Oklahoma City, Oklahoma, 73103
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Oklahoma City, Oklahoma, 73112
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Oklahoma City, Oklahoma, 73120
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Old Point Station, South Carolina, 29707
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Omaha, Nebraska, 68114
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Omaha, Nebraska, 68124
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Omaha, Nebraska, 68130
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Omaha, Nebraska, 68134
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Omaha, Nebraska, 68144
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Opelousas, Louisiana, 70570
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Orange Park, Florida, 32073
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Orangeburg, South Carolina, 29118
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Orlando, Florida, 32792
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Orlando, Florida, 32803
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Orlando, Florida, 32811
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Orlando, Florida, 32825
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Ormond Beach, Florida, 32174
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Oviedo, Florida, 32765
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Owensboro, Kentucky, 42303
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Palm Desert, California, 92260
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Palm Springs, California, 92262
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Palmetto Bay, Florida, 33157
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Panama City, Florida, 32405
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Paramount, California, 90723
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Pelzer, South Carolina, 29669
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Pembroke Pines, Florida, 33024
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Pembroke Pines, Florida, 33029
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Pensacola, Florida, 32503
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Peoria, Arizona, 85381
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Peoria, Illinois, 61602
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Philadelphia, Pennsylvania, 19152
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Phoenix, Arizona, 85012

Other trials in United States

Canada35 sites

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Ajax, Ontario, L1Z 0M1
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Bridgewater, Nova Scotia, B4V 3N2
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Burlington, Ontario, L7N 3V2
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Cornwall, Ontario, K6H 4M4
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Dorchester, Ontario, N0L 1G3
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Edmonton, Alberta, T5A 4L8
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Edmonton, Alberta, T5J 3S9
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Greater Sudbury, Ontario, P3A 1W8
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Greater Sudbury, Ontario, P3E 6C3
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Halifax, Nova Scotia, B3K2M5
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Hamilton, Ontario, L8K 3P3
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Kamloops, British Columbia, V2C 5T1
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Kelowna, British Columbia, V1Y 4N7
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Langley, British Columbia, V3A 4H9
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London, Ontario, N5Z 1R1
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London, Ontario, N6A 5G6
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Longueuil, Quebec, J4N 1C2
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Montreal, Quebec, H1M 1B1
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Newmarket, Ontario, L3Y 5G8
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Penticton, British Columbia, V2A 5C8
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Québec, Quebec, G1G 3Y8
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Québec, Quebec, G3K 2P8
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Saint-Charles-Borromée, Quebec, J6E 2B4
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Saskatoon, Saskatchewan, S7H 5M3
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St. John's, Newfoundland and Labrador, A1A 3R5
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Thorold, Ontario, L2V 5A7
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Toronto, Ontario, M3M 0B2
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Toronto, Ontario, M4S 1Y2
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Toronto, Ontario, M5T 3A9
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Toronto, Ontario, M9V 4B4
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Waterloo, Ontario, N2J 1C4
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West Vancouver, British Columbia, V7T 1E3
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Windsor, Ontario, N8X 5A6
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Windsor, Ontario, N8X-5A6
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Winnipeg, Manitoba, R2V 4W3

Other trials in Canada

About this study

Official title: Double-blind, Randomized, Placebo-controlled, Parallel-group, Phase IV Study to Evaluate the Effect of Aclidinium Bromide on Long-term Cardiovascular Safety and COPD Exacerbations in Patients With Moderate to Very Severe COPD (ASCENT COPD)

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.

Conditions: COPD, Chronic Obstructive Pulmonary Disease, Moderate to Very Severe COPD
Being tested: Aclidinium Bromide, Placebo
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01966107
Study group	Role	What they receive
Aclidinium Bromide	Experimental	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. Receives: Drug: Aclidinium Bromide
Placebo	Placebo comparator	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. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Rate of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Subject Per Year During the First Year of Treatment
The rate (number of events per subject per year) of moderate or severe COPD exacerbations during the first year of treatment based on on-treatment analysis with treatment group, baseline inhaled corticosteroids (ICS) use, baseline COPD severity, history of at least 1 exacerbation in the past year, and smoking status as factors and the log of the exposure time adjusted for the time the subjects experienced exacerbations as an offset variable.
Measured: 12 months
Number of Participants With Major Adverse Cardiovascular Event (MACE) - on Study Analysis
To assess the cardiovascular (CV) safety of aclidinium bromide on MACEs. The number of subjects with an adjudicated composite MACE with treatment group, baseline CV severity, and smoking status as factors. MACE for the analyses was defined as any adjudicated event which was a composite of the total of CV death, non-fatal myocardial infarction (MI), or non-fatal stroke (on-study analysis).
Measured: At Screening, Treatment period (upto 36 months) and Post-treatment follow-up (PTFU)

Secondary outcomes (2)

Rate of Hospitalizations Due to COPD Exacerbation Per Subject Per Year During the First Year of Treatment- on Treatment Analysis
To assess whether aclidinium bromide reduces moderate or severe COPD exacerbations. The rate of hospitalization (number of events per subject per year) due to COPD exacerbations during the first year of treatment based on on-treatment analysis with treatment group, baseline ICS use, baseline COPD severity, history of at least 1 exacerbation in the past year, and smoking status as factors and the log of the exposure time adjusted for the time the subjects experienced exacerbations as an offset variable.
Measured: 12 months
Number of Participants With Major Adverse Cardiovascular Event (MACE) or Other Serious Cardiovascular Events of Interest - On-study Analysis
To assess the CV safety of aclidinium bromide on MACEs. The number of subjects with an adjudicated MACE or other serious CV events of interest with treatment group, baseline CV severity, and smoking status as factors.
Other serious CV events included events from Cardiac tachyarrhythmias plus preferred terms (PTs) Tachycardia, Heart rate increase, and Palpitation; Cardiac failure; Bradycardia and PTs Sinus arrest and Sinus bradycardia; Conduction defects; Conditions associated with Central nervous system haemorrhages and cerebrovascular accidents; and selected PTs included in the Other ischemic heart disease.
Measured: At Screening, Treatment period (upto 36 months) and Post-treatment follow-up (PTFU)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Oct 201321 Sep 2017

First posted21 Oct 2013 (estimated)
Study start16 Oct 2013
Primary completion21 Sep 2017
Study completion21 Sep 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for COPDStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 3,635 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01966107
Sponsor's protocol ID: D6560C00002
Other IDs: LAS-MD-45
Acronym: ASCENT COPD
Status last verified: Nov 2018
First submitted: 16 Oct 2013
Last updated: 6 Dec 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Chapman KR, Wise RA, Scirica BM, Bhatt DL, Daoud SZ, Lythgoe D, Gil EG. Long-acting antimuscarinic therapy in patients with chronic obstructive pulmonary disease receiving beta-blockers. Respir Res. 2021 Oct 22;22(1):272. doi: 10.1186/s12931-021-01861-2.
PubMed 34686204
Wise RA, Scirica BM, Bhatt DL, Daoud SZ, Chuecos F, Garcia Gil E, Chapman KR. Efficacy of Aclidinium Bromide According to Baseline Therapy: Post-Hoc Analysis of ASCENT-COPD Randomized Trial. Adv Ther. 2021 Oct;38(10):5381-5397. doi: 10.1007/s12325-021-01878-5. Epub 2021 Sep 15.
PubMed 34528220
Wise RA, Chapman KR, Scirica BM, Daoud SZ, Lythgoe D, Garcia-Gil E. The Impact of Exacerbation History on the Safety and Efficacy of Aclidinium in Patients with Chronic Obstructive Pulmonary Disease and Increased Cardiovascular Risk: ASCENT-COPD Trial. Int J Chron Obstruct Pulmon Dis. 2021 Mar 18;16:689-699. doi: 10.2147/COPD.S285068. eCollection 2021.
PubMed 33776428
Wise RA, Chapman KR, Scirica BM, Bhatt DL, Daoud SZ, Zetterstrand S, Reisner C, Gil EG. Effect of Aclidinium Bromide on Major Cardiovascular Events and Exacerbations in High-Risk Patients With Chronic Obstructive Pulmonary Disease: The ASCENT-COPD Randomized Clinical Trial. JAMA. 2019 May 7;321(17):1693-1701. doi: 10.1001/jama.2019.4973.
PubMed 31063575

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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COPD, Smoking
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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive

All COPD trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Double-blind, Randomized, Placebo-controlled, Parallel-group, Phase IV Study to Evaluate the Effect of Aclidinium Bromide on Long-term Cardiovascular Safety and COPD Exacerbations in Patients With Moderate to Very Severe COPD (ASCENT COPD)
ClinicalTrials.gov ID: NCT01966107
Acronym / sponsor ID: ASCENT COPD / D6560C00002
Conditions: COPD, Chronic Obstructive Pulmonary Disease, Moderate to Very Severe COPD
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 3,635 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 16 Oct 2013 (actual)
Primary completion: 21 Sep 2017 (actual)
Study completion: 21 Sep 2017 (actual)
First posted: 21 Oct 2013 (estimated)
Results: Posted 6 Dec 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Aclidinium Bromide	Experimental	Drug: Aclidinium BromideTwo-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.
Placebo	Placebo comparator	Drug: PlaceboTwo-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.

Who may qualify

Ages: 40 to 130 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (18 listed)

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:
5. Maintained stable respiratory medications for 2 weeks prior to randomization (Appendix II)

Key exclusion criteria (16 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Aclidinium Bromide400 μg, twice per day, oral administration via a multi-dose dry-powder inhaler (DPI)	Drug	Aclidinium Bromide
PlaceboDose matched placebo, twice per day, oral administration via a multi-dose dry-powder inhaler (DPI)	Drug	Placebo

Primary outcome

Rate of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Subject Per Year During the First Year of Treatment
Time frame: 12 months
The rate (number of events per subject per year) of moderate or severe COPD exacerbations during the first year of treatment based on on-treatment analysis with treatment group, baseline inhaled corticosteroids (ICS) use, baseline COPD severity, history of at least 1 exacerbation in the past year, and smoking status as factors and the log of the exposure time adjusted for the time the subjects experienced exacerbations as an offset variable.
Number of Participants With Major Adverse Cardiovascular Event (MACE) - on Study Analysis
Time frame: At Screening, Treatment period (upto 36 months) and Post-treatment follow-up (PTFU)
To assess the cardiovascular (CV) safety of aclidinium bromide on MACEs. The number of subjects with an adjudicated composite MACE with treatment group, baseline CV severity, and smoking status as factors. MACE for the analyses was defined as any adjudicated event which was a composite of the total of CV death, non-fatal myocardial infarction (MI), or non-fatal stroke (on-study analysis).

2 secondary outcomes

Rate of Hospitalizations Due to COPD Exacerbation Per Subject Per Year During the First Year of Treatment- on Treatment Analysis
Time frame: 12 months
Number of Participants With Major Adverse Cardiovascular Event (MACE) or Other Serious Cardiovascular Events of Interest - On-study Analysis
Time frame: At Screening, Treatment period (upto 36 months) and Post-treatment follow-up (PTFU)

Results and safety

Results posted to the registry on 6 Dec 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Aclidinium Bromide	1,812	1,010
Placebo	1,818	937

Primary outcome: Rate of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Subject Per Year During the First Year of Treatment

Time frame: 12 months. Number (95% Confidence Interval). Unit: Events per subject per year

Measure	Aclidinium Bromide n = 1791	Placebo n = 1798
Value	0.44 (0.40 to 0.50)	0.57 (0.52 to 0.64)

Population analysed: The Full Analysis Set (FAS) population consisted of all subjects in the Randomized Population who took at least one dose of the double-blind IP (aclidinium bromide or placebo). Subjects were analyzed according to their randomized treatment.

Primary outcome: Number of Participants With Major Adverse Cardiovascular Event (MACE) - on Study Analysis

Time frame: At Screening, Treatment period (upto 36 months) and Post-treatment follow-up (PTFU). Count of participants. Unit: Participants

Measure	Aclidinium Bromide n = 1791	Placebo n = 1798
Number of subjects with events	69	76

Aclidinium Bromide vs Placebo: Hazard Ratio (HR): 0.89 (95% CI 0.64 to 1.23)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Any adverse event occurring from the time the informed consent form was signed until 15 days after the last dose of study drug were recorded. Adverse events were collected at Visit 1A for subjects who completed a Visit 0.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Aclidinium Bromide	409 of 1,791 (22.8%)	1,105 of 1,791 (61.7%)	75 of 1,791
Placebo	356 of 1,798 (19.8%)	1,065 of 1,798 (59.2%)	64 of 1,798

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34686204Chapman KR, Wise RA, Scirica BM, Bhatt DL, Daoud SZ, Lythgoe D, Gil EG. Long-acting antimuscarinic therapy in patients with chronic obstructive pulmonary disease receiving beta-blockers. Respir Res. 2021 Oct 22;22(1):272. doi: 10.1186/s12931-021-01861-2.
Derived from this study: PubMed 34528220Wise RA, Scirica BM, Bhatt DL, Daoud SZ, Chuecos F, Garcia Gil E, Chapman KR. Efficacy of Aclidinium Bromide According to Baseline Therapy: Post-Hoc Analysis of ASCENT-COPD Randomized Trial. Adv Ther. 2021 Oct;38(10):5381-5397. doi: 10.1007/s12325-021-01878-5. Epub 2021 Sep 15.
Derived from this study: PubMed 33776428Wise RA, Chapman KR, Scirica BM, Daoud SZ, Lythgoe D, Garcia-Gil E. The Impact of Exacerbation History on the Safety and Efficacy of Aclidinium in Patients with Chronic Obstructive Pulmonary Disease and Increased Cardiovascular Risk: ASCENT-COPD Trial. Int J Chron Obstruct Pulmon Dis. 2021 Mar 18;16:689-699. doi: 10.2147/COPD.S285068. eCollection 2021.
Derived from this study: PubMed 31063575Wise RA, Chapman KR, Scirica BM, Bhatt DL, Daoud SZ, Zetterstrand S, Reisner C, Gil EG. Effect of Aclidinium Bromide on Major Cardiovascular Events and Exacerbations in High-Risk Patients With Chronic Obstructive Pulmonary Disease: The ASCENT-COPD Randomized Clinical Trial. JAMA. 2019 May 7;321(17):1693-1701. doi: 10.1001/jama.2019.4973.
ProtocolLink provided by the sponsor.
Statistical Analysis Plan (SAP)Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kenneth R. Chapman, MD MSc FRCPC FACP FCCP principal investigator

GSK-CIHR Research Chair in Respiratory Health Care Delivery,

Robert Wise, MD principal investigator

Johns Hopkins Bayview Medical Center, Asthma and Allergy Center

468 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Aclidinium Bromide in people with COPD and Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 468 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 468 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Subject Per Year During the First Year of Treatment (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01966107, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2018.