2003 OPEN FORUM Abstracts
TREATMENT WITH CELLMUNE? (AM3), AN ORAL IMMUNOMODULATOR, INCREASES THE QUALITY OF LIFE OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) PATIENTS
Álvarez-Sala JL and Álvarez-Mon M. on behalf of the research group Departamento de Medicina. Universidad de Alcalá. Madrid. Spain.
COPD is the 4th leading cause of death in the United States and affects up to 600 million people worldwide. This chronic disease has a severe impact in the quality of life of the patients. Although the intrinsic mechanisms involved in the pathogenesis of COPD are partially unknown, it has been shown that it is frequently associated with several immune disturbances. These immune abnormalities appear to be involved in the inflammatory stage of these patients and in their high incidence of respiratory infections. These clinical manifestations impact the quality of life of COPD patients. Cellmune (AM3) is an orally effective immunomodulator treatment able to normalize defective antimicrobial functions of immune system effector cells of COPD patients (Am J Respir Crit Care Med 2001;163:1578-1583). We have investigated the clinical effects of Cellmune (AM3) treatment in the quality of life of COPD patients.
MATERIAL AND Methods: 349 COPD patients were randomized in a double-blind clinical trial to receive either Cellmune (AM3) (186 patients, mean age 67.50 ± 8.41) or placebo (178 patients, mean age 67.88 ± 7.86) (3 g/day) orally for 90 consecutive days. The smoking history of the patients was 54.00± 24.76 pack/year in the Cellmune (AM3) and 60.19 ± 30.10 in placebo arm, the percentage of active smokers in both arms was 18.75% and 18.29%, respectively. The mean FEV1(%) in the Cellmune (AM3) arm was 50.19 and in the placebo arm 48.58 and FEV1/FVC(%) was 58.61 and 55.17, respectively. The quality of life in the patients was measured by the St George's Respiratory Questionnaire (SGRQ).
RESULTS: Prior to treatment, there were not significant differences in the basic clinical characteristic of the patients included in both arms of the study. Pretreatment SGRQ total score was similar in both arms of the study (42.18 and 43.79 in Cellmune (AM3) and placebo arm, respectively). After 90 days of treatment the quality of life was significantly higher in the Cellmune (AM3) arm than in the placebo arm as measured by SGRQ total score (32.91 Cellmune (AM3) arm and 37.48 placebo arm, mean difference -4.57, p=0.0374). Symptoms (mean difference -2.98). Activities (mean difference -7.8). Impacts (mean difference -4.2). The clinical, biochemical and hematological tolerance was good and similar in both arms of the study.
Conclusions: Cellmune (AM3) is a safe, easily tolerated, effective treatment that increases the quality of life of COPD patients as measured by SGQR.