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Treatment With the Immunomodulator AM3 Improves the Health-Related Quality of Life of Patients With COPD^*

Melchor Alvarez-Mon, MD, PhD; Marc Miravitlles, MD, PhD; Josep Morera, MD, PhD; Luis Callol, MD, PhD and José L. Alvarez-Sala, MD, PhD

^* From the Department of Medicine (Dr. Alvarez-Mon), CSIC R&D Associated Unit, Hospital Príncipe de Asturias, Alcalá University, Alcalá de Henares, Madrid; Respiratory Department (Dr. Miravitlles), Hospital Clinic (IDIBAPS), Barcelona; Respiratory Department (Dr. Morera), Hospital German Trias i Pujol, Badalona; Respiratory Department (Dr. Callol), Hospital Central de la Defensa, Complutense University, Madrid; and Respiratory Department (Dr. Alvarez-Sala), Hospital Clínico San Carlos, Complutense University, Madrid, Spain. See ^Appendix for a complete list of study participants.

Correspondence to: Melchor Alvarez-Mon, MD, PhD, Departmento de Medicina, Universidad de Alcalá, Carretera Madrid-Barcelona, Km 33,600, E-28871 Alcalá de Henares (Madrid), Spain; e-mail: mams{at}tsai.es

Background: COPD has a severe impact on patient quality of life. AM3 is an orally effective immunomodulator that can normalize the defective antimicrobial functions of the immune system effector cells of COPD patients.

Objectives: We analyzed the effect of AM3 on exacerbation frequency and health-related quality of life (HRQL) of COPD patients with moderate disease.

Design: A randomized, double-blind, placebo-controlled trial.

Setting: Outpatient departments of 21 hospitals.

Methods: A total of 253 COPD patients with a mean age of 67.7 years (SD, 8.1 years) and mean FEV₁ percentage of predicted of 49.6% (SD, 10.2%) were evaluated. Patients received (orally) either 3 g/d AM3 or a matched placebo for 180 consecutive days. Patient quality of life was measured using the St. George’s Respiratory Questionnaire (SGRQ).

Results: There were no differences in the exacerbation frequency of the two groups (0.82 episodes per patient in the AM3 arm vs 0.84 in the placebo arm), and 55.3% of patients were exacerbation free in the AM3 arm compared to 48.8% in the placebo arm (p = 0.11). At the end of treatment, quality of life was significantly better in the AM3 arm than in the placebo arm (SGRQ total score, 32.9; SD, 16.4, compared to 37.5; SD, 17.5 [p < 0.05]: activity score, 47.5; SD, 22.4, compared to 54.6; SD, 20.5 [p < 0.05]). The improvements in total SGRQ scores were 8.9 U (SD, 13.4 U) in the AM3 arm and 5.6 U (SD, 15.9 U) in the placebo arm (p = 0.076). Improvements on the symptoms subscale were 15.9 U (SD, 20.7 U) for the AM3 arm and 10.2 U (SD, 21.3 U) for the placebo arm (p < 0.05). Both AM3 and the placebo were clinically, biochemically, and hematologically well tolerated.

Conclusions: AM3 is a safe, easily tolerated, effective treatment that improves the quality of life of COPD patients as measured by SGRQ scores. This effect was observed with no significant reduction in the frequency of exacerbations.

Key Words: AM3 • clinical trial • COPD • health-related quality of life • St. George’s Respiratory Questionnaire

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