Clinical trial NCT01966107: Evaluate the Effect of Aclidinium Bromide on Long-term Cardiovascular Safety and Exacerbations in Moderate to Very Severe COPD Patients.
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: COPD
Chronic Obstructive Pulmonary Disease
Moderate to Very Severe COPD
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2013-10-21
Enrollment: 3635
Sex: ALL
Minimum age (years): 40
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Rate of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Subject Per Year During the First Year of Treatment
timeFrame: 12 months
measure: Number of Participants With Major Adverse Cardiovascular Event (MACE) - on Study Analysis
timeFrame: At Screening, Treatment period (upto 36 months) and Post-treatment follow-up (PTFU)
Secondary outcomes:
measure: Rate of Hospitalizations Due to COPD Exacerbation Per Subject Per Year During the First Year of Treatment- on Treatment Analysis
timeFrame: 12 months
measure: Number of Participants With Major Adverse Cardiovascular Event (MACE) or Other Serious Cardiovascular Events of Interest - On-study Analysis
timeFrame: At Screening, Treatment period (upto 36 months) and Post-treatment follow-up (PTFU)
Other outcomes:
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facility: Research Site
state: New York
city: Asheville
country: United States
facility: Research Site
state: North Carolina
city: Burlington
country: United States
facility: Research Site
state: North Carolina
city: Calabash
country: United States
facility: Research Site
state: North Carolina
city: Charlotte
country: United States
facility: Research Site
state: North Carolina
city: Charlotte
country: United States
facility: Research Site
state: North Carolina
city: Charlotte
country: United States
facility: Research Site
state: North Carolina
city: Gastonia
country: United States
facility: Research Site
state: North Carolina
city: Greensboro
country: United States
facility: Research Site
state: North Carolina
city: Greenville
country: United States
facility: Research Site
state: North Carolina
city: Hendersonville
country: United States
facility: Research Site
state: North Carolina
city: High Point
country: United States
facility: Research Site
state: North Carolina
city: Huntersville
country: United States
facility: Research Site
state: North Carolina
city: Lenoir
country: United States
facility: Research Site
state: North Carolina
city: Monroe
country: United States
facility: Research Site
state: North Carolina
city: Monroe
country: United States
facility: Research Site
state: North Carolina
city: Mooresville
country: United States
facility: Research Site
state: North Carolina
city: New Bern
country: United States
facility: Research Site
state: North Carolina
city: Pinehurst
country: United States
facility: Research Site
state: North Carolina
city: Salisbury
country: United States
facility: Research Site
state: North Carolina
city: Shelby
country: United States
facility: Research Site
state: North Carolina
city: Statesville
country: United States
facility: Research Site
state: North Carolina
city: Tabor City
country: United States
facility: Research Site
state: North Carolina
city: Whiteville
country: United States
facility: Research Site
state: North Carolina
city: Wilmington
country: United States
facility: Research Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Research Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Research Site
state: North Carolina
city: Fargo
country: United States
facility: Research Site
state: North Dakota
city: Akron
country: United States
facility: Research Site
state: Ohio
city: Canton
country: United States
facility: Research Site
state: Ohio
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Columbus
country: United States
facility: Research Site
state: Ohio
city: Columbus
country: United States
facility: Research Site
state: Ohio
city: Dayton
country: United States
facility: Research Site
state: Ohio
city: Dayton
country: United States
facility: Research Site
state: Ohio
city: Dayton
country: United States
facility: Research Site
state: Ohio
city: Delaware
country: United States
facility: Research Site
state: Ohio
city: Dublin
country: United States
facility: Research Site
state: Ohio
city: Kettering
country: United States
facility: Research Site
state: Ohio
city: Maumee
country: United States
facility: Research Site
state: Ohio
city: Sylvania
country: United States
facility: Research Site
state: Ohio
city: Toledo
country: United States
facility: Research Site
state: Ohio
city: Toledo
country: United States
facility: Research Site
state: Ohio
city: Norman
country: United States
facility: Research Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Tulsa
country: United States
facility: Research Site
state: Oklahoma
city: Tulsa
country: United States
facility: Research Site
state: Oklahoma
city: Yukon
country: United States
facility: Research Site
state: Oklahoma
city: Portland
country: United States
facility: Research Site
state: Oregon
city: Portland
country: United States
facility: Research Site
state: Oregon
city: Altoona
country: United States
facility: Research Site
state: Pennsylvania
city: Beaver
country: United States
facility: Research Site
state: Pennsylvania
city: Belle Vernon
country: United States
facility: Research Site
state: Pennsylvania
city: Bensalem
country: United States
facility: Research Site
state: Pennsylvania
city: Carnegie
country: United States
facility: Research Site
state: Pennsylvania
city: Clairton
country: United States
facility: Research Site
state: Pennsylvania
city: Downingtown
country: United States
facility: Research Site
state: Pennsylvania
city: Erie
country: United States
facility: Research Site
state: Pennsylvania
city: Feasterville-Trevose
country: United States
facility: Research Site
state: Pennsylvania
city: Jefferson Hills
country: United States
facility: Research Site
state: Pennsylvania
city: Levittown
country: United States
facility: Research Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Research Site
state: Pennsylvania
city: Scottdale
country: United States
facility: Research Site
state: Pennsylvania
city: Smithfield
country: United States
facility: Research Site
state: Pennsylvania
city: Uniontown
country: United States
facility: Research Site
state: Pennsylvania
city: Wyomissing
country: United States
facility: Research Site
state: Pennsylvania
city: Yardley
country: United States
facility: Research Site
state: Pennsylvania
city: East Providence
country: United States
facility: Research Site
state: Rhode Island
city: Anderson
country: United States
facility: Research Site
state: South Carolina
city: Charleston
country: United States
facility: Research Site
state: South Carolina
city: Charleston
country: United States
facility: Research Site
state: South Carolina
city: Charleston
country: United States
facility: Research Site
state: South Carolina
city: Columbia
country: United States
facility: Research Site
state: South Carolina
city: Easley
country: United States
facility: Research Site
state: South Carolina
city: Gaffney
country: United States
facility: Research Site
state: South Carolina
city: Gaffney
country: United States
facility: Research Site
state: South Carolina
city: Greenville
country: United States
facility: Research Site
state: South Carolina
city: Greenville
country: United States
facility: Research Site
state: South Carolina
city: Greer
country: United States
facility: Research Site
state: South Carolina
city: Hodges
country: United States
facility: Research Site
state: South Carolina
city: Indian Land
country: United States
facility: Research Site
state: South Carolina
city: Mount Pleasant
country: United States
facility: Research Site
state: South Carolina
city: Myrtle Beach
country: United States
facility: Research Site
state: South Carolina
city: Orangeburg
country: United States
facility: Research Site
state: South Carolina
city: Pelzer
country: United States
facility: Research Site
state: South Carolina
city: Rock Hill
country: United States
facility: Research Site
state: South Carolina
city: Spartanburg
country: United States
facility: Research Site
state: South Carolina
city: Spartanburg
country: United States
facility: Research Site
state: South Carolina
city: Summerville
country: United States
facility: Research Site
state: South Carolina
city: Union
country: United States
facility: Research Site
state: South Carolina
city: Rapid City
country: United States
facility: Research Site
state: South Dakota
city: Athens
country: United States
facility: Research Site
state: Tennessee
city: Chattanooga
country: United States
facility: Research Site
state: Tennessee
city: Fayetteville
country: United States
facility: Research Site
state: Tennessee
city: Franklin
country: United States
facility: Research Site
state: Tennessee
city: Hendersonville
country: United States
facility: Research Site
state: Tennessee
city: Knoxville
country: United States
facility: Research Site
state: Tennessee
city: Smyrna
country: United States
facility: Research Site
state: Tennessee
city: Spring Hill
country: United States
facility: Research Site
state: Tennessee
city: Tullahoma
country: United States
facility: Research Site
state: Tennessee
city: Amarillo
country: United States
facility: Research Site
state: Texas
city: Arlington
country: United States
facility: Research Site
state: Texas
city: Austin
country: United States
facility: Research Site
state: Texas
city: Beaumont
country: United States
facility: Research Site
state: Texas
city: Boerne
country: United States
facility: Research Site
state: Texas
city: Carrollton
country: United States
facility: Research Site
state: Texas
city: Corsicana
country: United States
facility: Research Site
state: Texas
city: Cypress
country: United States
facility: Research Site
state: Texas
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Dickinson
country: United States
facility: Research Site
state: Texas
city: Duncanville
country: United States
facility: Research Site
state: Texas
city: Fort Worth
country: United States
facility: Research Site
state: Texas
city: Fort Worth
country: United States
facility: Research Site
state: Texas
city: Georgetown
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Irving
country: United States
facility: Research Site
state: Texas
city: North Richland Hills
country: United States
facility: Research Site
state: Texas
city: Richardson
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Spring
country: United States
facility: Research Site
state: Texas
city: Sugar Land
country: United States
facility: Research Site
state: Texas
city: Sugar Land
country: United States
facility: Research Site
state: Texas
city: Tomball
country: United States
facility: Research Site
state: Texas
city: Tyler
country: United States
facility: Research Site
state: Texas
city: Waco
country: United States
facility: Research Site
state: Texas
city: Webster
country: United States
facility: Research Site
state: Texas
city: Midvale
country: United States
facility: Research Site
state: Utah
city: Murray
country: United States
facility: Research Site
state: Utah
city: Ogden
country: United States
facility: Research Site
state: Utah
city: Riverton
country: United States
facility: Research Site
state: Utah
city: South Burlington
country: United States
facility: Research Site
state: Vermont
city: Abingdon
country: United States
facility: Research Site
state: Virginia
city: Manassas
country: United States
facility: Research Site
state: Virginia
city: Richmond
country: United States
facility: Research Site
state: Virginia
city: Richmond
country: United States
facility: Research Site
state: Virginia
city: Richmond
country: United States
facility: Research Site
state: Virginia
city: Richmond
country: United States
facility: Research Site
state: Virginia
city: Richmond
country: United States
facility: Research Site
state: Virginia
city: Bellevue
country: United States
facility: Research Site
state: Washington
city: Bellingham
country: United States
facility: Research Site
state: Washington
city: Everett
country: United States
facility: Research Site
state: Washington
city: Port Orchard
country: United States
facility: Research Site
state: Washington
city: Spokane Valley
country: United States
facility: Research Site
state: Washington
city: Spokane
country: United States
facility: Research Site
state: Washington
city: Tacoma
country: United States
facility: Research Site
state: Washington
city: Charleston
country: United States
facility: Research Site
state: West Virginia
city: Lewisburg
country: United States
facility: Research Site
state: West Virginia
city: Morgantown
country: United States
facility: Research Site
state: West Virginia
city: Edmonton
country: Canada
facility: Research Site
state: Alberta
city: Edmonton
country: Canada
facility: Research Site
state: Alberta
city: Kamloops
country: Canada
facility: Research Site
state: British Columbia
city: Kelowna
country: Canada
facility: Research Site
state: British Columbia
city: Langley
country: Canada
facility: Research Site
state: British Columbia
city: Penticton
country: Canada
facility: Research Site
state: British Columbia
city: West Vancouver
country: Canada
facility: Research Site
state: British Columbia
city: Winnipeg
country: Canada
facility: Research Site
state: Manitoba
city: St. John's
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: Bridgewater
country: Canada
facility: Research Site
state: Nova Scotia
city: Halifax
country: Canada
facility: Research Site
state: Nova Scotia
city: Ajax
country: Canada
facility: Research Site
state: Ontario
city: Burlington
country: Canada
facility: Research Site
state: Ontario
city: Cornwall
country: Canada
facility: Research Site
state: Ontario
city: Dorchester
country: Canada
facility: Research Site
state: Ontario
city: Hamilton
country: Canada
facility: Research Site
state: Ontario
city: London
country: Canada
facility: Research Site
state: Ontario
city: London
country: Canada
facility: Research Site
state: Ontario
city: Newmarket
country: Canada
facility: Research Site
state: Ontario
city: Sudbury
country: Canada
facility: Research Site
state: Ontario
city: Sudbury
country: Canada
facility: Research Site
state: Ontario
city: Thorold
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Waterloo
country: Canada
facility: Research Site
state: Ontario
city: Windsor
country: Canada
facility: Research Site
state: Ontario
city: Windsor
country: Canada
facility: Research Site
state: Ontario
city: Longueuil
country: Canada
facility: Research Site
state: Quebec
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: St Charles Borromee
country: Canada
facility: Research Site
state: Quebec
city: Saskatoon
country: Canada
facility: Research Site
state: Saskatchewan
city: Quebec
country: Canada
facility: Research Site
city: Quebec
country: Canada
facility: Research Site
Study officials:
affiliation: GSK-CIHR Research Chair in Respiratory Health Care Delivery,
name: Kenneth R. Chapman, MD MSc FRCPC FACP FCCP
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins Bayview Medical Center, Asthma and Allergy Center
name: Robert Wise, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.