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FAQ of Breathing
Research Related to Spinal Cord Injuries
Question: How
does theophylline work to improve function of respiratory muscles
either weakened or completely paralyzed
by spinal cord injury?
Answer: Theophylline belongs to the same family of drugs as caffeine
and just like caffeine, theophylline is found naturally in coffee, tea and
cocoa. We all know that coffee is a natural stimulant that can help keep
us awake and more alert. This happens because nerve cells in the brain
are stimulated by the drugs that are in coffee.
When theophylline is taken as a pill or when the doctor administers the drug
intravenously, the concentrated medicine works in much the same way by actually
stimulating different types of nerve cells in the brain.
The nerve cells in the brain that control breathing are one of the types of
cells that theophylline stimulates. When these cells are stimulated,
the impulses are increased over the pathway connecting the brain cells with
the spinal cord cells that make the respiratory muscles contract. Thus,
the theophylline-induced increase of respiratory command impulses down into
the spinal cord from the brain activates previously latent connections between
the brain and spinal cord centers that control breathing. The result
is recovery of respiratory muscle function.
If you want more detailed information, please consult one of our
studies: Nantwi
and Goshgarian, Neuropharmacolgy 37:113-121, 1998.
Question: What type of patient
are you looking for to participate in your clinical studies involving
theophylline?
Answer: The patient should be between 18 and 65 years old, have a documented
mid to high (C2-C6) cervical spinal cord injury with some breathing insufficiencies
and be in stable clinical condition. Breathing insufficiencies could
include, but are not limited to, shortness of breath, difficulty in coughing
or clearing mucus secretions from the respiratory passages. Presently,
we are seeking patients who are not ventilator-dependent, but we will be including
ventilator-dependent patients in the future.
Question: What criteria would
exclude a patient from the clinical study?
Answer: A patient would not
be an acceptable subject for our clinical study if the patient sustained
a spinal cord injury within the last three months;
had a history of active lung, heart, kidney or liver disease; or had a documented
intolerance to theophylline.
Question: Will other medications
that I may be taking affect theophylline's effectiveness in improving
muscle function?
Answer: Generally no, but a
select few antibiotics and the medication dilantin (a medication
to control seizures) should not be taken with theophylline.
We ask that all patients inquiring about participating in the study provide
us with a list of medications that they will be taking at the time of the study.
Question: Are there any side
effects of theophylline?
Answer: If taken in very high does, theophylline could cause nervousness,
insomnia, cardiac arrhythmias or seizures. We carefully monitor the amount
of drug given to the patient during the procedure to insure that the drug is
delivered in safe amounts at therapeutic levels. Some people experience
an upset stomach and nausea with theophylline that is usually lessened if it
is taken with food. Thus, although there is some potential risk, the risk is
quite small compared to the potential benefits that may be realized by the
patient.
Question: If a patient lives
outside of Michigan, can they participate in your clinical studies?
Answer: Yes. We have no geographical limitations imposed on the
subjects that we accept in our Michigan-based studies. However, we do
not have the resources to reimburse patients for travel expenses incurred by
the patient to travel to Michigan for the testing procedures. We can,
however, provide free hotel accommodations and a food allowance during your
visit to Detroit for the testing. Our current study requires 4 visits to the
VA hospital in Detroit, Michigan spaced out at about 6-week intervals. The
visits only last 1-2 hours.
Question: Is theophylline an
experimental drug and how expensive is it?
Answer: Theophylline is not an experimental drug. It has been used
clinically for decades in the treatment of lung diseases such as asthma, bronchitis
and chronic obstructive pulmonary disease (COPD). There are many drug
companies that manufacture theophylline and it is relatively inexpensive. We
will provide the patient with all the theophylline needed during the clinical
study at no cost to the patient.
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