Randomized, Placebo-Controlled, Double-Blind, Dose Ranging, Single Dose, 6-Way Crossover Study to Assess the Safety, Efficacy and Pharmacokinetics of EP-101 Using eFlow Nebulizer in Patients with COPD

Elevation Pharmaceuticals, Inc.0 个研究点开始时间: 2010年6月18日最近更新: 2012年3月19日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•1. Male or female age 40 through 75 years, inclusive
•2. A clinical diagnosis of COPD according to the GOLD guidelines
•3. Current smokers or ex-smokers with at least 10 pack-year smoking history (e.g., at least 1 pack/day for 10 years, or 10 packs/day for 1 year)
•4. Post-bronchodilator FEV1 30-70% of predicted normal at the Screening Visit
•5. Post-bronchodilator FEV1/FVC ratio < 0.70 at the Screening Visit
•6. Improvement in FEV1 >12% and 150 mL following inhalation of ipratropium bromide at the Screening Visit
•7. Ability to perform reproducible spirometry according to the ATS/ERS guidelines
•8. Willing to stay at the study site for at least 30 hours on each treatment visit
•9. Willing and able to provide written informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

排除标准

•1. Females who are pregnant or lactating at the Screening Visit, or if of childbearing potential not using one of the following acceptable means of birth control throughout the study:
•a. Abstinence
•b. Post-menopausal for at least two years
•c. Surgically sterile (i.e., tubal ligation, hysterectomy)
•d. Oral contraceptives (taken for at least one month prior to the Screening Visit)
•e. Approved implantable or injectable contraceptives (e.g., Norplant®, Depo-Provera® or equivalent)
•f. Barrier methods (e.g., condoms with spermicide)
•g. Intrauterine device (i.e., IUD)
•h. Vasectomy of male partner
•i. Non-heterosexual life style
•2. Current evidence or recent history of any clinically significant disease (other than COPD) or abnormality in the opinion of the Investigator that would put the subject at risk or which would compromise the quality of the study data; including but not limited to cardiovascular disease, myocardial infarction, cardiac failure, uncontrolled hypertension, life-threatening arrhythmias, uncontrolled diabetes, neurologic or neuromuscular disease, liver disease, gastrointestinal disease or electrolyte abnormalities
•3. Recent history of hospitalization due to an exacerbation of airway disease within 3 months or need for increased treatments for COPD within 6 weeks prior to the Screening Visit
•4. Primary diagnosis of asthma
•5. Prior lung volume reduction surgery or history of chest/lung irradiation
•6. Regular use of daily oxygen therapy
•7. Use of systemic steroids within 3 months prior to the Screening Visit
•8. Respiratory tract infection within 6 weeks prior to the Screening Visit
•9. History of tuberculosis, bronchiectasis or other non-specific pulmonary disease
•10. History of urinary retention or bladder neck obstruction type symptoms
•11. History of narrow-angle glaucoma
•12. Clinically significant abnormal ECG
•13. Positive Hepatitis B surface antigen or positive Hepatitis C antibody
•14. Positive screening test for HIV antibodies
•15. Current or recent history (previous 12 months) of excessive use or abuse of alcohol
•16. Current evidence or history of abusing legal drugs or use of illegal drugs or substances
•17. Donation of 450 mL of blood within 8 weeks of the Screening Visit
•18. History of hypersensitivity or intolerance to aerosol medications
•19. Participation in another investigational drug study where drug was received within 30 days prior to the Screening Visit

研究者

发起方

Elevation Pharmaceuticals, Inc.

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