Asthma study for subjects using oral steroids

What we are studying

You have been asked to consider taking part in this study because you have severe asthma that is not well controlled and requires the use of oral corticosteroids. This study is being carried out to evaluate benralizumab (study drug) as a medicine to treat severe asthma compared with placebo (an inactive substance). Asthma is a lung disease associated with inflammation (swelling) of the air passages. Certain proteins made by the body, called interleukins, are thought to be important in causing inflammation. One of these proteins, interleukin-5 (IL-5), appears to play a major role in asthma. IL-5 is important for the survival and activation of white blood cells called eosinophils, that are involved in inflammation of the air passages. Benralizumab is an antibody made in the laboratory that has been made to block the effect of IL-5 at the eosinophil. Antibodies are proteins naturally produced by your body that find foreign substances such as bacteria, fungi, viruses and other substances that enter your body and make them inactive. Benralizumab may help decrease inflammation in the air passages of people with asthma. Preliminary studies in people with moderate-to-severe asthma have shown an improvement in asthma control in those who received benralizumab. The purpose of this study is to see if benralizumab, given as injections under the skin for once every 4 weeks or once every 8 weeks, for a total of 24 weeks, can reduce the dose of your oral corticosteroids and help control your asthma better if it is added to currently available asthma medications (eg anti-inflammatory inhaled steroid also referred to as inhaled corticosteroids (ICS) and a long lasting airway opener also referred to as long acting ß-agonists (LABA)). This study will explore whether benralizumab helps to reduce oral corticosteroids dependence, how often benralizumab needs to be given, who responds best to benralizumab, and how well benralizumab is tolerated. This study will measure levels of benralizumab in the blood and see how the body accepts the study drug.

Who we are studying

  • Men and Women
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • All Ethnicities
  • Ages 18 - 80

Eligibility Criteria

  • Diagnosed with asthma
  • Non smoker (less than 100 cigarettes in your life)
  • Currently using daily oral steroids for at least 6 months
  • Using additional inhaled asthma medications

What is involved

  • Informed consent
  • Medical and asthma history
  • Complete physical examination
  • Brief physical examination
  • Vital Signs
  • ECG
  • Local laboratory eosinophil test
  • Serum chemistry
  • Hematology
  • Urinalysis
  • Serology (hepatitis B
  • C; HIV-1; HIV-2)
  • Serum pregnancy test
  • Fshb
  • Asthma Daily Diary adherence check
  • ACQ-6 adherence check
  • AQLQ(S)+12 adherence check
  • Assessment of asthma exacerbations
  • Urine pregnancy test (dipstick)
  • OCS dose titration
  • Pre-BD Spirometry
  • Post-BD spirometry for Sputum collection
  • Body plethysmography (3 times)

Contact Information

Study Coordinator
Bob Hmieleski
Email
bhmieles@wfubmc.edu
Phone
336-713-8550
Principal Investigator
Dr. Eugene Bleecker

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.