Trial Information

Summary: The prevalence of asthma is growing - new research focuses on preventing allergic airway inflammation, regarded as an important factor in asthma

The purpose of this study is to evaluate the efficacy of three different doses of an investigational study drug compared to placebo as measured by change in an asthma control questionnaire from baseline to Week 12.

We are seeking volunteers 18 to 65 years old and in general good health who are currently receiving an inhaled corticosteroid medication (such as Flovent, Pulmicort, Aerobid, Azmacort, QVAR) for asthma.

STUDY INFORMATION:

• Male or female adults 18 to 65 years of age
• Study duration: Study participants will be in the study for approximately 20 weeks.
• Study treatment: One of 3 different doses of study medication or placebo (an inactive treatment). The chance of receiving placebo is 1 in 4. The study drug will be administered in the study office by injection once weekly for 12 consecutive weeks (2 injections per dose). These visits must take place during the morning, and will last approximately 45 minutes. The investigational medication is a human monoclonal antibody that blocks the biologic activity of two particular cytokines (chemical signaling compounds found in the human body), which are implicated in the development of asthma symptoms.
• There is no charge for participation (study procedures, study medication, and study visits are no-cost).
• Compensation will be provided to participants to help cover study-related time and/or travel. Total possible compensation is $750 ($25 at 6 of the visits and $50 at the 12 visits requiring study drug injections).
• Principal Investigator: Lawrence Repsher, M.D.

INCLUSION CRITERIA (partial list):

• Study participants must be currently receiving an inhaled corticosteroid medication for asthma. The requirement is between 200 & 1000 ?g/day of fluticasone or equivalent medication (Flovent, Pulmicort, Aerobid, Azmacort, QVAR) for at least the last 3 months at a stable dose for at least 30 days.
• Females of childbearing potential or (wives of childbearing potential of male study participants) must be using a highly effective method of birth control.
• Study participants must be non-smokers or ex-smokers (who have quit at least one year ago), and must have smoked the equivalent of not more than one pack a day for ten years.

EXCLUSION CRITERIA (partial list):

• Study participants may not have a history of an acute episode of asthma that required emergency room treatment or hospitalization within the past 3 months.
• Study participants may not have a history of endotracheal intubation (having a tube inserted in the airway to help with breathing) during the past 3 years.
• Females who are pregnant or lactating may not participate.
• Study participants may not have a chronic breathing illness other than asthma.

Please contact our site for further information about this study!

If you would like to learn more about participating in this study, please send an e-mail message using the form below.