THE PREVALENCE OF ASTHMA IS GROWING - NEW RESEARCH FOCUSES ON PREVENTING ALLERGIC AIRWAY INFLAMMATION, REGARDED AS AN IMPORTANT FACTOR IN ASTHMA

We are seeking volunteers 18 to 55 years old and in general good health who are currently receiving an inhaled corticosteroid medication (such as Flovent, Pulmicort, Aerobid, Azmacort, QVAR) for asthma.

SUMMARY: 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.

STUDY INFORMATION:

• Male or female adults 18 to 55 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 medications, 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 & 1,000 µg/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 more information about this study!

CONTACT INFORMATION:

Amber Bretz, Mary Reid, Cheri Casey, Jodi Frazier, and Dara Stillman

Western States Clinical Research, Inc.
Telephone: 303-940-0909
FAX: 303-940-0308
E-mail: research@wscrinc.com  

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Our mission is to promote the health and well-being of humanity by the development of new medicines through high-quality clinical research and a closely held philosophy of striving for excellence.

To find out about the studies that are currently underway at our office, please see Clinical Trials.

Western States Clinical Research Inc. specializes in research studies related to gastroenterology, asthma and allergy, pulmonology, internal medicine, women's health, ophthalmology and dermatology. Our website contains information for physicians, pharmaceutical companies and individuals interested in participating in clinical research.

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