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Title: BELT: Blacks and Exacerbations on LABA vs. Tiotropium
Principal Investigator: Pedro Avila, MD
Funded by: AHRQ Grant 1 R01 HS019408-01

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?

We are doing this study to learn how genes affect the way that people, specifically Black people, respond to treatment for asthma. We are asking you to take part in this study because you are relatively healthy other than having asthma. We are also asking you because you take medications for asthma like Advair© or Symbicort© or inhaled corticosteroids. 

People with asthma are told to use an inhaled beta agonist medication to treat their asthma symptoms. These beta agonist medications include short-acting ones such as albuterol (Ventolin©, for example), and long-acting ones (called LABAs) such as salmeterol and formoterol (Serevent© and Foradil©). Recent studies suggest that people respond differently to these LABA medications. Some people feel better when they use these inhalers, but others may not and some people get worse. It seems that this difference shows up more often in Blacks than in Whites, which is why we are looking for Black subjects for this study. In all people, this difference seems to depend on their genes or DNA.

If you take part in this study, your asthma medications might change. In this study, we will assign people randomly (by chance, like the flip of a coin) to two groups. People in one group will take a LABA medication such as salmeterol or formoterol (Serevent© or Foradil©). People in the other group will take a medication called Tiotropium (Spiriva©). Tiotropium is an inhaled anticholinergic medication, which relieves symptoms of asthma Subjects in both groups will also be taking an inhaled corticosteroid medication such as fluticasone (Flovent©) or budesonide (Pulmicort©).

Tiotropium (Spiriva©) is approved by the U.S. Food and Drug Administration to treat a lung disease called COPD (chronic obstructive pulmonary disease). Tiotropium is not FDA approved to treat asthma so its use in this study is investigational. We have received special permission from the FDA to use this medication in this study. All the other medications that are used in this study are FDA approved to treat asthma.

In this study, LABA medications are always used in combination with an inhaled corticosteroid (ICS) medication, a controller drug. LABAs should not be used without the ICS. When used alone LABAs do not protect well against asthma attacks and may increase the risk of severe asthma attacks or death.

We plan to enroll 1500 people in this study at medical practices across the country. About 100 of those people will be enrolled here at Northwestern University. 

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 Northwestern Medical Faculty Foundation, Galter Pavilion, 18th Floor, 675 N. St. Clair Street, Chicago, IL 60611.

 You will be in this study for one year.

  • You will have four study visits over 52 weeks (1 year) at Northwestern University. Study visits vary in length from 45 minutes to 90 minutes. The study visits do not replace any office visits you would normally have with your doctor.
  • Between study visits you will be asked to complete questions sent to you in the mail each month. These will take about 20 minutes to answer.