Western States Clinical Research, Inc. and Dr. Jeffrey Rumbyrt are now enrolling in a clinical research study for adults 18-75 years old, with severe, uncontrolled asthma despite use of standard asthma therapy.
About the study medication: This research study is investigating the safety and effectiveness of an investigational medication being compared to a placebo (an inactive substance, like a “sugar pill”).The study medication is thought to work by targeting a new family of inflammatory cells that the body makes when you have a respiratory virus or inhale an allergen. These powerful inflammatory cells can cause other immune system cells found in the lungs to react, which can lead to tissue injury. By blocking this inflammatory response , the study medication may decrease lung inflammation across a broader range of the asthma patient population, regardless of the cause.
Eligible subjects will be randomly assigned by chance (like the flip of a coin), to one of three possible study medication groups or to the placebo group.
- One group will receive 70 mg of study medication, another group will receive 210 mg and the third group will receive 490 mg of study medication.
- Neither the study volunteer nor the research staff or physicians will know which group the subject is assigned.
- The study medication will be administered to eligible subjects as four subcutaneous (under the skin) injections in the abdomen every 4 weeks for almost a year.
Duration of the Study and Visit Information:
- Study volunteers will undergo a screening process that may last up to three weeks to determine eligibility and establish baseline conditions.
- Those who qualify at the end of the screening period will be allowed to enroll in the 54-week treatment phase.
- Enrolled subjects will return to the research site every four weeks for study medication dosing and safety/efficacy evaluations.
- At the end of the study treatment phase, subjects will continue to be evaluated in the follow up phase for an additional 16 weeks.
If you, or someone you know, is interested in this study and to see if you maybe eligible to participate, please call (303) 940-9773.