Gulf War Illness Inflammation Reduction Trial

During Desert Shield and Desert Storm (Aug 2, 1990 to July 31,1991) 696,841 United States
Military personnel were deployed to the Kuwaiti Theater of Operations. Today approximately
one-third of those veterans are suffering from GWI, an unexplained chronic multi-symptom
illness. Evidence of chronic inflammation in veterans with GWI has emerged from previous
observational studies. The goal of this trial is to determine if reducing the GWI-associated
chronic inflammation is an effective treatment for GWI. This is a randomized, two group,
placebo controlled, double blind clinical trial. The treatment group will receive a low dose
(2x5mg) once a day of delayed-release prednisone (Rayos) for 8 weeks. The placebo group will
receive matching placebo (2x5mg) once a day for 8 weeks. The primary outcome measure for this
clinical trial is a change from baseline of HRQOL with respect to physical functioning and
symptoms. The secondary outcome measures include changes from baseline of peripheral blood
levels of GWI-associated biomarkers of inflammation, changes from baseline of GWI-associated
symptoms (chronic pain, fatigue, and cognitive impairment), and a change from baseline of
HRQOL with respect to mental functioning.

Inclusion Criteria:

- Scores moderate-severe on at least 3 out of 6 domains from the Kansas GWI Case
Definition

- Deployed, (and honorably discharged), from the Kuwaiti Theater of Operation (August 2,
1990-July 31, 1991)

Exclusion Criteria:

- Hospitalization anytime since 1990 for Alcohol or Drug Dependence, Depression, or PTSD

- Known hypersensitivity to Prednisone

- Liver, (active or recent Hepatitis B or C treatment with a completion date within the
past 6 months, or alcohol liver disease), or Kidney Disease (Hep B and C ok if after 6
months of treatment)

- Treated Diabetes

- Females who are Pregnant or Nursing

- Female who refuses to use an accepted method of birth control

- Exclusionary Labs: C-Reactive Protein >25, Creatinine Clearance <30, EFGR ≥ 30, Hgb
A1-C >7, Glucose >120, WBC >12, RBC >6.2, Hematocrit >60, Hemoglobin <11, Platelets
<100, Liver Function Tests (2 x the upper limit of AST and ALT, 2 x the upper limit of
Total Bilirubin, and Alkaline Phosphatase)

- Has Inflammatory Arthritis (RA, or Psoriatic Arthritis, Spondylitis, Polyarthritis)

- Reactive Arthritis, or IBD associated Arthritis

- Has any major inflammatory disease (acute Chronic Infections, Ulcerative Colitis,
Crohn's Disease, Inflammatory lung diseases- COPD or Asthma requiring steroid
treatment, Pericarditis, Vasculitis)

- Has an chronic/active infection

- Chronic use of Prednisone or Corticosteroids (occasional inhaled use of steroids
acceptable)

- Active Gum Disease or Dental Infection

- Has been diagnosed with Lupus, Stroke, or Multiple Sclerosis. or any other diagnosis
that produces symptoms of fatigue, cognitive impairment, or pain will be excluded
based on the Kansas GWI Case definition

- Has a condition that may interfere with the ability to accurately report symptoms,
(Severe Psychiatric Problems, Schizophrenia, Bipolar Disorder, Alcohol or Drug
Dependence requiring hospitalization, or regular illegal drug use)

- Heart Disease (other than Hypertension), Heart Failure or Coronary Heart Disease
requiring hospitalization within the past 12 months

- Cancer (other than basal cell skin cancer), requiring treatment within the past 12
months, or life expectancy of less than 1 year.

- Hospitalization within the past 3 months