Comparing the Effects of Symbicort to Inhaled Steroid Alone in Asthma Subjects

What we are studying

This study, which was mandated by the United States Food and Drug Administration (FDA), is being done to help answer an important safety question about long acting beta-agonists, a type of drug to treat asthma, specifically formoterol, a component of Symbicort. People with asthma are at risk for uncommon but serious problems such as hospitalization, needing to have a tube put down their throat to help them breathe, or death due to asthma. The question is whether patients taking inhaled corticosteroids such as budesonide in combination with formoterol (Symbicort) have the same risk of having these serious problems as patients taking the inhaled corticosteroids (budesonide) alone.

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 12+

Eligibility Criteria

  • Diagnosed with asthma for 1 year
  • Able to sign consent or have a parent sign the consent
  • Have had a worsening of asthma requiring oral steroids or a shot of steroids
  • Or a hospital stay because of asthma
  • Currently be using an inhaled corticosteroid
  • Cannot be a current or past smoker
  • Cannot have any other breathing diseases besides asthma

What is involved

  • Two screening visits
  • 6 visits over the next 182 days
  • One follow-up visit

Compensation

You will be paid $495.00 to compensate you for your time and travel in this study if you complete all the scheduled study visits. If you withdraw for any reason from the study before completion you will be paid 75.00 for each complete study visit conducted at the Cloverdale Clinical Research Center and $30.00 for each phone call..

Contact Information

Study Coordinator
Bob Hmieleski
Email
bhmieles@wakehealth.edu
Phone
336-713-8550
Principal Investigator
Eugene Bleecker, MD

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.