Study to Evaluate the Safety and Dose-Range of SCH 527123 in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (Study P04592AM4)(COMPLETED)
Summary
This is a two-part study conducted at multiple centers, in subjects with moderate to severe COPD. Part 1 of the study is a double-blind, placebo-controlled, randomized, rising-dose study consisting of four treatment groups enrolled in three cohorts. The duration of treatment, for each cohort, will be a 2-week run-in period, followed by a 12-week double-blind treatment period. Part 2 of the study will be a double-blind, placebo-controlled, randomized, parallel group study consisting of four treatment groups enrolled as one cohort. The duration of treatment will consist of a 2-week run-in period, followed by a 12-week double-blind treatment period.
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Conditions
Chronic Obstructive Pulmonary Disease
Intervention
Drug 1: SCH 527123, Drug 2: Placebo to match SCH 527123, Drug 3: SCH 527123, Drug 4: Placebo to match SCH 527123, Drug 5: SCH 527123, Drug 6: Placebo to match SCH 527123, Drug 7: SCH 527123, Drug 8: SCH 527123, Drug 9: SCH 527123, Drug 10: Placebo to matc
Status
Completed
Source
Schering-Plough
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00441701
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Drug Carriers
Forms to which substances are incorporated to improve the delivery and the effectiveness of drugs. Drug carriers are used in drug-delivery systems such as the controlled-release technology to prolong in vivo drug actions, decrease drug metabolism, and reduce drug toxicity. Carriers are also used in designs to increase the effectiveness of drug delivery to the target sites of pharmacological actions. Liposomes, albumin microspheres, soluble synthetic polymers, DNA complexes, protein-drug conjugates, and carrier erythrocytes among others have been employed as biodegradable drug carriers.
Drug Resistance
Diminished or failed response of an organism, disease or tissue to the intended effectiveness of a chemical or drug. It should be differentiated from DRUG TOLERANCE which is the progressive diminution of the susceptibility of a human or animal to the effects of a drug, as a result of continued administration.
United States Office Of National Drug Control Policy
A component of the Executive Office of the President established by the Anti-Drug Abuse Act of 1988. The Office establishes policies, priorities, and objectives for national DRUG AND NARCOTIC CONTROL. The goals of the program are to reduce illicit drug use, manufacturing, and trafficking, drug-related crime and violence, and drug-related health consequences.
Drug Interactions
The action of a drug that may affect the activity, metabolism, or toxicity of another drug.
Drug Synergism
The action of a drug in promoting or enhancing the effectiveness of another drug.
Clinical Trials
Long-Term Extension Study of the Effects of SCH 527123 in Subjects With Moderate to Severe COPD
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Evaluation of treatment in subjects with mild asthma.
Neutrophilic Asthma Study With SCH 527123 (Study P05365AM2)(COMPLETED)
4-Week Safety Study in Subjects with Neutrophilic Asthma
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