Clinical Trial 37897

Sacramento, CA 95821


Summary:

Northern California Research is currently enrolling participants for an asthma study. The purpose of this study is to look at the effects of three different doses of an experimental inhaled steroid, study medication, compared to a placebo and a marketed version, Qvar,of that same steroid on asthmatics. The study medication is a steroid that has been used to treat asthma for 40 years However, this formulation is not approved by the U.S. FDA.

Our participants will be ages 18-75 years of age who have a diagnosis of asthma for at least 1 year. Participants must be using an inhaler for the past 3 months and been on a stable dose (no changes in your medication). If you have a diagnosis of COPD or are a current smoker you would not be able to qualify for this study.

This is a double-blind study, which means neither you nor the study doctor will know what medication group you will be placed into. You will be randomly assigned by chance (like rolling a dice) into one out of 5 different study medication groups: You have an equal chance of being in any of the 5 study groups.

·         Study treatment A: study medication 100 micrograms Total Daily Dose

·         Study treatment B: study medication 400 micrograms Total Daily Dose

·         Study treatment C: study medication 800 micrograms Total Daily Dose

·         Study treatment D: Placebo: (canister looks like treatment A, B, C but there is no active study medication)

·         Study treatment E: Qvar 320 micrograms Total Daily Dose

The study is a 3 months long. It includes 5 office visits and 1 telephone call.


Qualified Participants Must:

• Be 18 years of age or older
• Be diagnosed with asthma for at least 1 year
• Be on two inhalers to manage asthma


Qualified Participants May Receive:

All trial-related visits, tests, and medications will be provided to you at no cost. In addition, reimbursement for trial-related time and travel may be provided. Please fill out the survey and we will be contacting you to provide study specific information.


Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.