Clareo Health | Evaluate the Effect of Aclidinium Bromide on Long-term Cardiovascular Safety and Exacerbations in Moderate to Very Severe COPD Patients.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
AstraZeneca
Age
40–130
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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:
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
You may not be if
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
