A Phase 4 clinical study for patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD) who experience COPD exacerbations.

  • STATUS
    Recruiting
Updated on 25 March 2021

Summary

A Phase 4 clinical study for patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD) who experience COPD exacerbations.

Description

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.

Details
Clinical Study IdentifierTX137901
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 40 yrs and None yrs?
Gender: Male or Female
Male or female outpatients ≥ 40 years of age
Current or former cigarette smokers with a smoking history of at least 10 pack-years
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
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)
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
At least 1 documented moderate or severe COPD exacerbation (Section 9.5.1.1) within 1 year prior to screening
Maintained stable respiratory medications for 2 weeks prior to randomization (Appendix II)
Able to perform pulmonary function test (PFT) maneuvers and follow study procedures
Women of childbearing potential must have a negative serum ß-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)
Should understand study procedures and be willing to participate in the study as indicated by signing the ICF

Exclusion Criteria

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
Unstable or life threatening cardiovascular disease or COPD as determined by the PI
Patients with comorbid lung disease such as asthma, cystic fibrosis, bronchiectasis, interstitial lung disease, or pulmonary thromboembolic disease
Planned lung transplant or lung volume reduction surgery
Currently treated with a combination of LAMA and LABA/ICS therapy
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
Respiratory infection or COPD exacerbation at Screening and/or within 4 weeks prior to screening
Uncontrolled infection resulting from human immunodeficiency virus (HIV) and/or active hepatitis
Reported history of drug or alcohol abuse within the past 12 months
Other protocol-defined inclusion/exclusioncriteria may apply
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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