New Drug for Asthmatic Subjects Between the Ages of 12 and 16

What we are studying

The purpose of this study is to find out if the study drug offers any benefit in treating adolescents (aged 12-16 years) who suffer from asthma that is uncontrolled despite the use of inhaled corticosteroids and a second controller medication. The subject must have asthma for at least 1 year and his or her asthma symptoms (such as wheeze, chest tightness, cough, or shortness of breath) have continued even though he or she has been taking an inhaled corticosteroid and a second medication for his or her asthma symptoms for at least 6 months. The sponsor hopes to learn whether the study treatment will improve symptoms and lung function in asthma patients.

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 - 16

Eligibility Criteria

  • Must have been diagnosed with asthma for 1 year
  • Using a steroid and another controller medication
  • Breathing between 40 and 90 percent of predicted
  • Breathing improves by 12 percent after using a rescue medication
  • Still experiencing asthma problems
  • The ability to keep an electronic diary.

What is involved

  • This clinical study will have 2 treatment periods including a placebo-controlled period (52 weeks) and an active treatment extension period (52 weeks)
  • 3 safety follow-up visits

Contact Information

Study Coordinator
Bob Hmieleski

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.