0
Clinical Investigations: COPD |

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; José L. Alvarez-Sala, MD, PhD
Author and Funding Information

Affiliations: *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@tsai.es



Chest. 2005;127(4):1212-1218. doi:10.1378/chest.127.4.1212
Text Size: A A A
Published online

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.

Figures in this Article

Sign In to Access Full Content

MEMBER & INDIVIDUAL SUBSCRIBER

Want Access?

NEW TO CHEST?

Become a CHEST member and receive a FREE subscription as a benefit of membership.

Individuals can purchase this article on ScienceDirect.

Individuals can purchase a subscription to the journal.

Individuals can purchase a subscription to the journal or buy individual articles.

Learn more about membership or Purchase a Full Subscription.

INSTITUTIONAL ACCESS

Institutional access is now available through ScienceDirect and can be purchased at myelsevier.com.

Sign In to Access Full Content

MEMBER & INDIVIDUAL SUBSCRIBER

Want Access?

NEW TO CHEST?

Become a CHEST member and receive a FREE subscription as a benefit of membership.

Individuals can purchase this article on ScienceDirect.

Individuals can purchase a subscription to the journal.

Individuals can purchase a subscription to the journal or buy individual articles.

Learn more about membership or Purchase a Full Subscription.

INSTITUTIONAL ACCESS

Institutional access is now available through ScienceDirect and can be purchased at myelsevier.com.

Figures

Tables

References

NOTE:
Citing articles are presented as examples only. In non-demo SCM6 implementation, integration with CrossRef’s "Cited By" API will populate this tab (http://www.crossref.org/citedby.html).

Some tools below are only available to our subscribers or users with an online account.

Sign In to Access Full Content

MEMBER & INDIVIDUAL SUBSCRIBER

Want Access?

NEW TO CHEST?

Become a CHEST member and receive a FREE subscription as a benefit of membership.

Individuals can purchase this article on ScienceDirect.

Individuals can purchase a subscription to the journal.

Individuals can purchase a subscription to the journal or buy individual articles.

Learn more about membership or Purchase a Full Subscription.

INSTITUTIONAL ACCESS

Institutional access is now available through ScienceDirect and can be purchased at myelsevier.com.

Related Content

Customize your page view by dragging & repositioning the boxes below.

Find Similar Articles
CHEST Journal Articles
PubMed Articles
  • CHEST Journal
    Print ISSN: 0012-3692
    Online ISSN: 1931-3543