Combination Therapy for Poorly Controlled Asthma

Trial Objective

The purpose of this research study is to determine if adding an investigational medication to an existing therapy is safe and effective in treating patients with poorly controlled moderate to severe asthma.

Combination Therapy for Poorly Controlled Asthma

The Food and Drug Administration (FDA) has not approved this investigational medication for the treatment of asthma. The medication is not available for purchase or through a prescription in any country. Approximately 75 people have been treated with this medication in clinical studies to date. A placebo that looks like the investigational medication, but does not contain active medicine, also will be used in the study.

Enrollment

This trial is active and currently recruiting.

How to Participate

For more information, call 303.398.1443 or complete the form below.

Who Can Participate

Adults with moderate to severe asthma that is not well controlled by other therapies may be eligible to participate. Any additional medications the patient is taking need to have been a stable part of their regimen for at least three months. Additional medications should include at least a medium dose of an inhaled glucocorticoid, such as Advair Diskus or Symbicort, and at least one additional asthma-control medication.


Estimated Time Commitment

7 1/2 months

Study participation will last for approximately seven and a half months, including 15 screening days, a pre-randomization period of 30 days, administration of the investigational medication or placebo over three months, and three months to evaluate treatment effects and perform safety assessments. Participants will complete 15 visits totaling about 20 hours.

Trial Location

National Jewish Main Campus, Denver, CO

Compensation

Provided

Trial Sponsors

Pharmaceutical company

Age

18-75


Gender

Any Gender

Principal Investigators


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