ANDHI Study – Adults with Severe Asthma

STUDY BASICS

Do you have severe, uncontrolled asthma? Are you currently using an inhaled corticosteroid? You may be able to take part in a research study to find out if an investigational drug called benralizumab is a safe and effective treatment for people with severe asthma. Compensation provided.

STUDY PURPOSE

Severe asthma, which affects approximately 5%-10% of asthmatics, can be difficult to treat. The purpose of this research study is to help find out if an investigational drug called benralizumab is a safe and effective treatment for people with severe asthma. Benralizumab is a type of drug called a monoclonal antibody that works with the body’s immune system to destroy blood cells called eosinophils. Eosinophils play a role in inflammation and contribute to asthma symptoms such as chest tightness, shortness of breath, wheezing, and coughing. Researchers hope their findings will lead to better treatments for people with severe asthma.

COULD THIS STUDY BE RIGHT FOR YOU?

• Ages 18-75
• Diagnosed with severe uncontrolled asthma at least 1 year ago
• Currently using an inhaled corticosteroid (such as Advair, Symbicort, Dulera, Alvesco, or Breo), and have been using this medicine for at least 1 year
• Have had 2 or more asthma flare ups requiring the use of steroids (oral, IV, or injection) in the past 12 months
• Are a non-smoker or quit smoking at least 6 months ago
• Former smokers must have a less than 10 pack year history (less than 1 pack a day for ten years or less than 2 packs a day for 5 years)

WHAT PARTICIPANTS CAN EXPECT

Participation involves up to 12 visits over about 8 months. Participants will complete the following tests and assessments: physical exams, medical history, electrocardiogram (ECG), questionnaires, breathing tests, blood draws, and at-home monitoring using a peak flow meter and electronic diary. It is important to know that participants in this research study will be randomly assigned (like the flip of a coin) to receive the study drug benralizumab or to receive a placebo. A placebo is an inactive substance that looks like the study drug, but does not contain any drug. Both benralizumab and placebo are given by injection 4 times over a 16-week period.