A Study to Evaluate the Efficacy of MEDI-528 on Late Asthmatic Response With Atopic Asthma
Summary
This is a Phase 2a, randomized multicenter study to evaluate the efficacy of MEDI-528 on LAR in adult patients with atopic asthma.
Description
This study (MI-CP138) is a Phase 2a, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy of MEDI-528 on LAR in adult patients with atopic asthma. Approximately three investigative sites in Canada will participate in this study, with up to 40 evaluable patients randomized in a 1:1 ratio to receive MEDI-528 (9.0 mg/kg) or placebo as a single IV infusion.
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Conditions
Intervention
MEDI-528, Placebo
Location
McMaster University
Hamilton
Ontario
Canada
L8N 3Z5
Status
Completed
Source
MedImmune LLC
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00394654
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-07-24T14:23:32-0400
Clinical Trials
Study to Evaluate the Efficacy and Safety of MEDI-563 in Adults With Uncontrolled Asthma
The primary objective of the study is to evaluate the effect of multiple-dose subcutaneous administrations of MEDI-563 on adults with uncontrolled asthma.
A Study to Evaluate the Effectiveness and Safety of MEDI-528 in Adults
To study the safety and effectiveness of multiple-doses of MEDI-528 on asthma control in adults with uncontrolled, moderate-to-severe, persistent asthma.
A Study to Evaluate the Safety, Tolerability and Effects of MEDI-563 in Adults With Asthma
Evaluate the safety and tolerability of MEDI-563 in adults with asthma and the effects of MEDI-563 on eosinophil counts in airway mucosal biopsies
The main objective of this study is to evaluate the safety and tolerability of multiple fixed doses of MEDI-528 in adult patients with stable asthma and exercise-induced bronchoconstrictio...
The primary objective of this study is to evaluate the safety and tolerability of escalating multiple SC doses of MEDI-528 in adult patients with mild persistent asthma.
PubMed Articles
Alfred William (Bill) Frankland.
First double- blind, placebo - controlled trials in allergy: grass pollen immunotherapy proved effective. but bacterial vaccines lacked efficacy in asthma. First Secretary of BSACI. Instituted the UK ...
Eosinophils drive pathophysiology in stable and exacerbating eosinophilic asthma and therefore treatment is focused on the reduction of eosinophil numbers. Mepolizumab, a humanized monoclonal antibody...
Dupilumab Efficacy and Safety in Moderate-to-Severe Uncontrolled Asthma.
Background Dupilumab is a fully human anti-interleukin-4 receptor α monoclonal antibody that blocks both interleukin-4 and interleukin-13 signaling. We assessed its efficacy and safety in patients wi...
Efficacy and Safety of Dupilumab in Glucocorticoid-Dependent Severe Asthma.
Background Dupilumab is a fully human anti-interleukin-4 receptor α monoclonal antibody that blocks both interleukin-4 and interleukin-13 signaling. Its effectiveness in reducing oral glucocorticoid ...
Medical and Biotech [MESH] Definitions
Therapeutic Misconception
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
Asthma, Occupational
Asthma attacks caused, triggered, or exacerbated by OCCUPATIONAL EXPOSURE.
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.
Asthma, Exercise-induced
Asthma attacks following a period of exercise. Usually the induced attack is short-lived and regresses spontaneously. The magnitude of postexertional airway obstruction is strongly influenced by the environment in which exercise is performed (i.e. inhalation of cold air during physical exertion markedly augments the severity of the airway obstruction; conversely, warm humid air blunts or abolishes it).
Anti-asthmatic Agents
Drugs that are used to treat asthma.
