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The study is a multi-center, double-blind, placebo-controlled, cross-over study to evaluate the efficacy and safety of selected doses and dose intervals of the novel long acting beta agonist (LABA), GW642444 in asthmatic subjects ≥18 years of age who are currently receiving inhaled corticosteroid treatment.
The study will be a five-period cross-over study with each 7 day treatment period separated by a 7 day wash-out period. The study will enroll asthmatic subjects ≥18 years of age who are currently receiving inhaled corticosteroid treatment with an FEV1 of between 40-85% of predicted normal and with airway reversibility as demonstrated by an increase in FEV1 of ≥12% and ≥200ml .
Efficacy assessments include 24-hour serial lung function testing. Safety assessments include incidence of adverse events and measurement of vital signs.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Dose 4 QD, Dose 3 QD, placebo, Dose 2 QD, Dose 1 BD
GSK Investigational Site
Published on BioPortfolio: 2014-08-27T03:19:12-0400
The overall purpose of this study is to determine the efficacy of fevipiprant (dose 1 and dose 2 once daily), compared with placebo, as add-on to standard-of-care asthma therapy, in terms ...
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The dose amount of poisonous or toxic substance or dose of ionizing radiation required to kill 50% of the tested population.
A treatment schedule in which the total dose of radiation is divided into large doses.
The highest dose of a biologically active agent given during a chronic study that will not reduce longevity from effects other than carcinogenicity. (from Lewis Dictionary of Toxicology, 1st ed)
Administration of the total dose of radiation (RADIATION DOSAGE) in parts, at timed intervals.
The ratio of the dose that produces toxicity to the dose that produces a clinically desired or effective response.
Pulmonary relating to or associated with the lungs eg Asthma, chronic bronchitis, emphysema, COPD, Cystic Fibrosis, Influenza, Lung Cancer, Pneumonia, Pulmonary Arterial Hypertension, Sleep Disorders etc Follow and track Lung Cancer News ...
The term allergy is used to describe a response, within the body, to a substance, which is not necessarily harmful in itself, but results in an immune response and a reaction that causes symptoms and disease in a predisposed person, which in turn can cau...