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

NCT01966107 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 3635

Last updated 2018-12-06

Study results available
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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.

Conditions

Interventions

DRUG

Aclidinium Bromide

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

DRUG

Placebo

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

Sponsors & Collaborators

Principal Investigators

  • Kenneth R. Chapman, MD MSc FRCPC FACP FCCP · GSK-CIHR Research Chair in Respiratory Health Care Delivery,

  • Robert Wise, MD · Johns Hopkins Bayview Medical Center, Asthma and Allergy Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-16
Primary Completion
2017-09-21
Completion
2017-09-21

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01966107 on ClinicalTrials.gov