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.
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)MedDRA version: 8.1Level: LLTClassification code 10009033Term: Chronic obstructive pulmonary disease
- Registration Number
- EUCTR2006-002309-30-SK
- Lead Sponsor
- Schering-Plough Research Institute, a division of Schering Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1500
• 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 for at least 24 months.
• A subject must have a documented history of two or more COPD exacerbations requiring a course of oral corticosteroid and/or antibiotics within 2 - 12 months before screening.
• 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.
• 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 withdraw from parenteral steroids, long-acting anticholinergics, oral steroids and antibiotics 4 weeks prior to Screening (Visit 1).
• If, based on the medical judgement 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 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. This inclusion criterion is only applicable to certain centers that are selected to perform this procedure.
• 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 Sceening 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
• 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 - 400 mcg), or nebulized 2.5 mg albuterol/salbutaml.
• A diagnosis of asthma.
• Blood eosinophil count greater than 570/ug.
• A subject who has undergone lobectomy, pneumonectomy or lung volume reduction surgery.
• A diagnosis of lung cancer.
• A subject who requires long term administration of oxygen (> 15 hours per day).
• A subject who experiences an exacerbation of COPD requiring medical intervention within 8 weeks prior to randomization, use of oxygen therapy, beta-blocking agents or treatment with additional excluded medication (other than SABA/short-acting anticholinergics to the used as rescue medication).
• A subject with a clinically significant condition (eg cardiovascular disorder, diagnosis or cancer) or situation, other than the condition being studied which, in the opinion of the investigator, may interfere with the study evaluations or optimal participation in the study.
• A subject with cataract extractions on both eyes.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method