Introduction

You are being asked to take part in a research study. This document has important information about the reason for the study, what you will do if you choose to be in this research study, and the way we (Northwestern University) would like to use information about you and your health.

What is the reason for doing this study?

This study is being done to find out if taking vitamin D in addition to the inhaled steroid called Alvesco^® (ciclesonide), will help prevent worsening asthma symptoms and asthma attacks. Ciclesonide is approved by the FDA (US Food and Drug Administration) for the maintenance treatment of asthma.  Vitamin D is investigational and not approved by the FDA for the treatment of asthma.

You are being asked to take part in this study because you have asthma.  People with asthma have difficulty breathing, wheezing (a whistling noise when breathing), cough, sputum or phlegm production, inflammation (swelling, irritation, redness) and narrowing of the bronchial tubes.  Some people’s asthma remains uncontrolled even when they regularly take inhaled steroids. There are many possible reasons for this. One reason might be that inhaled steroids do not work as well in people with low vitamin D levels. Vitamin D helps the body in many ways including maintaining strong bones, helping muscles and nerves work and might or might not help asthma.  

If you agree to be in the study and are eligible, you will be asked to take the inhaled steroid, ciclesonide twice a day.  In addition to the inhaled steroid you will take either vitamin D or a look-alike placebo (inactive substance) once each day.   About half of the people in the study will be on vitamin D and half will be on placebo.  A placebo is an inactive substance made to look/taste like an active medication.  Researchers use placebos to see if the study drug (Vitamin D) is better or safer than not taking anything.  The assignment to a treatment is random, which means it is based on chance, like the flip of a coin.  Neither you nor the researcher chooses your assigned group.  You will have an equal chance of being in either group.  This information can be found out if needed in the case of an emergency.

The inhaled steroid will always be an active drug, but the amount of drug you take may be reduced during the study. Everyone will take a 5-7 day course of prednisone (an oral steroid that you take by mouth) between visits 3 and 4 to see how good your breathing tests can get with maximum therapy.

About 400 people across the nation will be randomized in this study. 50 people will be randomized here at Northwestern. 

What you will do if you choose to be in this study?

As a subject in this study, you will be asked to come to the Galter Pavilion to the 11^th or 18^th floor at 201 E. Huron, Chicago, IL 60611.  Your part in this study will involve 11 visits over a period of 35 weeks (about 9 months).  If your asthma worsens during the study as measured by a decrease in your  peak flow readings (a measure of how hard you can breathe out) or your rescue inhaler use increases, you may be asked to come in for one or more extra safety visits.