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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Forest Laboratories
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01966107
First received: October 16, 2013
Last updated: July 31, 2014
Last verified: July 2014
  Purpose

This study will be 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 (GOLD, 2011). 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.


Condition Intervention Phase
COPD
Chronic Obstructive Pulmonary Disease
Drug: Aclidinium Bromide
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Time to first Major Adverse Cardiovascular Event (MACE) [ Time Frame: up to 36 months ] [ Designated as safety issue: Yes ]
  • Rate of moderate or severe COPD exacerbations per patient per year during the first year of treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of hospitalizations due to COPD exacerbation per patient per year during the first year of treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Time to first Major Adverse Cardiovascular Event (MACE) or other serious cardiovascular events of interest [ Time Frame: up to 36 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 4000
Study Start Date: October 2013
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aclidinium Bromide
Aclidinium bromide 400 μg, twice per day, oral administration via a multi-dose dry-powder inhaler (DPI)
Drug: Aclidinium Bromide
Placebo Comparator: Placebo
Dose matched placebo, twice per day, oral administration via a multi-dose dry-powder inhaler (DPI)
Drug: Placebo

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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, 2011) with a postbronchodilator Forced Expiratory Volume in one second (FEV1) < 70% predicted and FEV1/forced vital capacity (FVC) ratio < 70% at Visit 1A
  • 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
  • 5. At least 1 documented moderate or severe COPD exacerbation (Section 9.5.1.1) within 1 year prior to screening
  • 6. Maintained stable respiratory medications for 2 weeks prior to randomization (Appendix II)
  • 7. Able to perform pulmonary function test (PFT) maneuvers and follow study procedures
  • 8. 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).
  • 9. 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01966107

Contacts
Contact: Sandra Beaird, Pharm.D 1-800-678-1605 ext 66297 FRXClinTrials@frx.com

  Show 521 Study Locations
Sponsors and Collaborators
Forest Laboratories
Investigators
Study Director: Michelle Patel, BA Forest Research Institute, a subsidiary of Actavis plc.
  More Information

No publications provided

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01966107     History of Changes
Other Study ID Numbers: LAS-MD-45
Study First Received: October 16, 2013
Last Updated: July 31, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Bromides
Anticonvulsants
Central Nervous System Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014