Two-Part Study to Evaluate the Dose Response of SCH 527123 on Sputum Neutrophilia Following Ozone Challenge in Healthy Subjects and Chronic Obstructive Pulmonary Disease (COPD) Patients (P05567 AM7)
Summary
Trial to evaluate the dose response of SCH 527123 in reducing inflammation from an ozone-induced sputum neutrophilia in both healthy subjects and subjects with COPD.
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)
Conditions
Chronic Obstructive Pulmonary Disease
Intervention
SCH 527123, SCH 527123, SCH 527123, SCH 527123, Placebo, SCH 527123, SCH 527123, SCH 527123, Placebo
Location
Investigational Site 1
Grosshansdorf
Germany
D-22927
Status
Recruiting
Source
Schering-Plough
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01068145
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Therapeutic Misconception
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
Placebo Effect
An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.
Clinical Trials
Study of SCH 527123 in Subjects With Severe Asthma (Study P05109AM1)
Given the strong inhibition of SCH 527123 on neutrophil migration to sites of inflammation, there is a theoretical reason for its use in patients with severe asthma where neutrophils are t...
Long-Term Extension Study of the Effects of SCH 527123 in Subjects With Moderate to Severe COPD
Neutrophils are thought to play an important role in the pathophysiology of COPD. It is theorized that reducing neutrophil migration to the diseased lung will improve a subject's symptoms...
Efficacy and Safety of SCH 527123 in Subjects With Allergen-Induced Asthma (Study P05363)(COMPLETED)
Evaluation of treatment in subjects with mild asthma.
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...
Neutrophilic Asthma Study With SCH 527123 (Study P05365AM2)(COMPLETED)
4-Week Safety Study in Subjects with Neutrophilic Asthma
PubMed Articles
Small molecule antagonists for CXCR2 and CXCR1 inhibit human colon cancer liver metastases.
CXCR1 and CXCR2 are G-protein coupled receptors, that have been shown to play important role in tumor growth and metastasis, and are prime targets for the development of novel therapeutics. Here, we r...
Placebo interventions, placebo effects and clinical practice.
This article reviews the role of placebo interventions and placebo effects in clinical practice. We first describe the relevance of different perspectives among scientists, physicians and patients on...
Placebo expectations and the detection of somatic information.
In a laboratory study we examined the hypothesis that placebo expectations enhance the initial identification of placebo-relevant sensations over placebo-irrelevant sensations. Participants (N = 102...
The silent healer: The role of communication in placebo effects.
Placebo effects have an ambiguous reputation, as they are associated with sham treatment and deceit on the one hand and as interesting phenomena, which might be clinically relevant on the other. The g...
The placebo response in clinical trials: more questions than answers.
Meta-analyses and re-analyses of trial data have not been able to answer some of the essential questions that would allow prediction of placebo responses in clinical trials. We will confront these que...
