School of Medicine

Based on the results of our study done at Botsford General Hospital in 1998, we decided to continue our work with theophylline and breathing function following SCI on a larger scale. Thus, the current study “Effect of Theophylline on Respiratory Muscle Strength in High Cervical Quadriplegia” was initiated in 2001 with all testing to be performed at the VA Hospital in Detroit, Michigan. The study is a cross-over, placebo-controlled study. That means that each participant in the study will take the medication (theophylline) at one point in the study and a placebo (sugar pill) at another point. This is done so that we will know with greater certainty that any changes we see in breathing strength is really due to the actions of the medicine and not for some other reason. In addition, the study is double-blind, meaning that the participant will not know whether he/she is taking the sugar pill or the theophylline nor will Dr. Tzelepis or Dr. Goshgarian. The double-blind design is put in place so that the participant will not anticipate certain results and thus unconsciously alter the way they perform the breathing tests, also the doctor administering the tests and interpreting the results will not be biased. We have an independent doctor that will be in charge of monitoring the medication part of the study.

Our research team includes the following:

Dr. Harry Goshgarian (left), Amy Bascom-Lattin (center), Dr. George Tzelepis (right).

Dr. Harry Goshgarian, designed and administrates the study

Dr. George Tzelepis, a pulmonary medicine physician at the VA Hospital in Detroit, Michigan, co-designed the study, administers the breathing tests, and interprets the data.

Amy Bascom-Lattin B.S., RRT, a respiratory therapist and a graduate student in Anatomy and Cell Biology working with Dr. Goshgarian, coordinates the logistics of the study, schedules patients, arranges transportation, draws blood work, monitors patient’s progress in the study and accompanies patients to each visit.

What are the requirements to be in the study?

• We are looking for people with a high cervical spinal cord injury (C2-6) who have experienced some level of breathing problems as a result of their injury. A weak cough, shortness of breath, inability to blow your nose, and a history of chest congestion and/or respiratory infections are some of the common signs of weak breathing muscles.
  
  
• Your injury cannot have occurred within the last 3 months.
  
  
• You must be between the ages of 18 and 65 years old.
  
  
• No underlying heart, lung (asthma, emphysema, fibrosis), kidney, or liver disease and no history of seizures.

I participate in the study what will I have to do?

The study requires 4 visits to the VA Hospital in Detroit, MI. Each visit lasts 1-2 hours. The study is laid out in the following way:

• Visit #1 to the VA Hospital. The details of the study will be explained to you by Dr. Tzelepis and you will need to sign a consent form. Next, you will take a series of simple, painless breathing tests. The whole visit takes 1-2 hours. We will send you home with medication (either the sugar pill or theophylline, you won't know which) to take twice a day for 6 weeks. A week to 10 days after you start taking the meds you will need to have blood drawn. This is to make sure that you have the proper blood level of theophylline. If you live within an hour of Detroit, Amy Bascom-Lattin will come to your home to draw the blood and if you live farther away we will arrange to have the blood drawn at a lab close to you at our expense.
  
  
• After you have taken the pills for 6 weeks we need you to come back for visit #2. Again, same location, same breathing test, and one blood draw to make sure that your medication blood level is correct on the day of testing. This visit will also be 1-2 hours max. Now you can go back home and forget about us for 8 weeks (no pills to take, nothing to do for us). This is a wash-out period to get the medication out of your system.
  
  
• After 8 weeks has passed you will come to the VA hospital again for visit #3. It will be identical to visit #1 except we will send you home with the opposite medication that you took the first time (if you had the real medication the first time, you would get the sugar pill this time, or vice versa). You will take the medication twice a day for 6 weeks with another blood draw a week or so after starting the new medication.
  
  
• After 6 weeks on the new medication, you will return to Detroit, MI for the final visit. This visit will be identical to visit #2. Now you are done with the study!!

Because of a generous grant from the State of Michigan we are able to provide free transportation to Michigan residents if needed and all participants (whether Michigan resident or not) will receive a $300.00 honorarium after completion of the study.

If you have any questions about the study or want to see if you are a candidate to participate, call Amy Bascom-Lattin at (313) 577-8143 or click on link below to send e-mail.

E-mail Amy Bascom-Lattin

Will this study help me?

No one has the answer to this question yet. The purpose of the study is to find out if theophylline will help strengthen the breathing muscles of individual who have sustained a cervical spinal cord injury. We cannot say whether the medication will be of any help to you personally. Any information that we can gain from this study can be applied to further development of treatment options for people with SCI and is therefore, valuable to medical science. Development of treatments takes a great deal of time, effort, and resources, and not all drugs studied turn out to have clinical benefit. We are constantly in search of potential medical treatment for the life threatening results of SCI and much more work needs to be done.