Efficacy and tolerability of immucytal® in the prevention and treatment of respiratory tract infections in adults: A randomized, placebo-controlled, double-blind study

G. B. Galioto, P. Galioto, E. Mevio, E. Mora, M. Bardieri, R. Mora, F. Mora, A. Ottaviani, F. Ottaviani

Research output: Contribution to journalArticle

7 Citations (Scopus)

Abstract

Recurrent respiratory tract infections are common in patients of all ages and are associated with high morbidity and high rates of medical consultations. Immunotherapy has long been used to boost the immune system and to confer protection against microbial infections. Ribosomal immunotherapy has been shown to stimulate both specific and nonspecific immune. responses, particularly the mucosal immune defense system. The aim of this study was to evaluate the efficacy and tolerability of an oral ribosomal immunostimulant (Immucytal® tablets) in the prevention and treatment of respiratory tract infections. This was a multicenter (n = 3), randomized, placebo-controlled, double-blind, parallel-group study. A total of 180 adult patients with recurrent upper respiratory tract infections (URTIs) or bronchitis were recruited from university clinics or hospitals. Immucytal® or placebo was administered according to the following schedule: 1 tablet/day for 4 days/week for 3 consecutive weeks (first month), followed by 1 tablet/day for 4 days every month for the following 5 months. The main efficacy parameter was a semiquantitative evaluation by a clinical score of clinical efficacy. The following items were considered: incidence of upper and lower respiratory tract infections, fever, number of medical consultations and adjunctive treatments required. At the end of the study the clinical score showed a significant reduction in patients treated with Immucytal® compared with placebo for all the most important items considered, starting at 2 months after treatment initiation. Concomitantly, there was a significant change in immunological parameters (increased plasma levels of IgG, IgE and IgA titers, higher counts of CD4+ and CD8+ lymphocyte subpopulations) and an improvement in respiratory function parameters. A significantly higher proportion of physicians and patients expressed a preference for Immucytal® vs. placebo (p

Original languageEnglish
Pages (from-to)31-40
Number of pages10
JournalInternational Journal of Immunotherapy
Volume17
Issue number1
Publication statusPublished - 2001

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Double-Blind Method
Respiratory Tract Infections
Placebos
Tablets
Immunotherapy
Immune System
Referral and Consultation
Immunologic Adjuvants
Bronchitis
Lymphocyte Subsets
Therapeutics
CD4 Lymphocyte Count
Immunoglobulin A
Immunoglobulin E
Appointments and Schedules
Fever
Immunoglobulin G
Morbidity
Physicians
Ribomunyl

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology

Cite this

Efficacy and tolerability of immucytal® in the prevention and treatment of respiratory tract infections in adults : A randomized, placebo-controlled, double-blind study. / Galioto, G. B.; Galioto, P.; Mevio, E.; Mora, E.; Bardieri, M.; Mora, R.; Mora, F.; Ottaviani, A.; Ottaviani, F.

In: International Journal of Immunotherapy, Vol. 17, No. 1, 2001, p. 31-40.

Research output: Contribution to journalArticle

Galioto, G. B. ; Galioto, P. ; Mevio, E. ; Mora, E. ; Bardieri, M. ; Mora, R. ; Mora, F. ; Ottaviani, A. ; Ottaviani, F. / Efficacy and tolerability of immucytal® in the prevention and treatment of respiratory tract infections in adults : A randomized, placebo-controlled, double-blind study. In: International Journal of Immunotherapy. 2001 ; Vol. 17, No. 1. pp. 31-40.
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