A Randomized Placebo-Controlled Efficacy and Safety Study of 1-Year Duration with High and Medium Dose Inhaled Mometasone Furoate/Formoterol Combination Formulation Compared With Formoterol and High Dose Inhaled Mometasone Furoate Monotherapy in Subjects with Moderate to Severe COPD.

Schering-Plough Research Institute, a division of Schering Corporation0 个研究点目标入组 1,000 人开始时间: 2006年11月1日最近更新: 2012年6月12日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方
入组人数: 1,000

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

•- A diagnosis of moderate to severe COPD based on a pre-bronchodilator FEV1/FVC ratio of <=70%.
•- At Screening, the subject’s post-bronchodilator FEV1 must be <=60% predicted normal and >=25% predicted normal.
•- A subject must have symptoms of COPD (chronic cough and sputum production that are not attributable to another disease process) for at least 24 months.
•- A subject must be an ex-smoker or current smoker with a smoking history of >=10 pack years. NOTE: Current smokers must provide verbal notification or written documentation that attests to their inability to stop smoking after participation (or declining to participate) in a smoking cessation program. Ex-smokers are defined as those who have stopped smoking at least 12 months prior to Visit 1.
•- A subject must have been on only SABA/short-acting anticholinergics for relief, for at least 2 weeks prior to randomization (Visit 2).
•- A subject must have a documented history of one or more COPD exacerbations requiring a course of oral corticosteroid and/or antibiotics within 2 to 14 months before screening.
•- A subject must withdraw from parenteral steroids, oral steroids and antibiotics at least 4 weeks prior to Screening (Visit 1).
•- If, based on the medical judgment of the investigator, there is no inherent harm in changing the subject’s current COPD therapy, the subject must be willing to discontinue his/her prescribed short-acting anticholinergics, ICS or ICS/LABA combination at the Screening Visit, and be transferred to treatment with SABA/short-acting anticholinergics for relief for 2 weeks prior to the Baseline/Randomization Visit.
•- The subject must have two valid scans, as confirmed by the local dual energy X-ray absorptiometry (DXA) centre for
•lumbar spine, left total femur (right femur will not be an acceptable substitute), and femoral neck prior to randomization. ’Valid scans’ are defined in the protocol.
•- Clinical laboratory tests (complete differential blood counts [CBC], blood chemistries, C-reactive protein, and urinalysis) conducted at the Screening Visit must be clinically acceptable to the investigator/sponsor. An electrocardiogram (ECG)
•performed at the Screening Visit must be clinically acceptable to the investigator. A chest X-ray performed at the Screening Visit or within 12 months prior to the Screening Visit must be clinically acceptable to the investigator.
•- A female subject of childbearing potential must be using a medically acceptable, adequate form of birth control, as defined in the protocol, and must have a negative serum pregnancy test at Screening in order to be considered eligible for enrollment.
•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. A subject who demonstrates an increase in absolute volume of =400 mL at the Screening Visit or prior to the Baseline Visit within 30 minutes after administration of four inhalations of albuterol/salbutamol (total dose of 360 to 400 mcg), or nebulized 2.5 mg albuterol/salbutamol.
•2. A current diagnosis of asthma.
•3. Blood eosinophil count greater than 0.57 x 103/µL.
•4. A subject who has undergone lobectomy, pneumonectomy or lung volume reduction surgery.
•5. A diagnosis of lung cancer.
•6. A subject who requires long-term administration of oxygen (>15 hours per day).
•7. A subject who experiences an exacerbation of COPD requiring medical intervention within 4 weeks prior to randomization or treatment with 3 additional excluded medication (other than SABA/short acting anticholintergic to be used as rescue medication.)
•8. Alpha-1-antitrypsin deficiency
•9. A subject with cataract extractions on both eyes.
•10. A subject with a history and/or presence of intraocular pressure in either eye ³22 mm Hg, glaucoma, and/or posterior subcapsular cataracts. A subject who has undergone incisional or intraocular surgery in which the natural lens is still present in the eye. A subject with a history of penetrating trauma to both eyes. A subject with one or more of the following LOCS III grades at screening:

研究者

发起方

Schering-Plough Research Institute, a division of Schering Corporation

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