Double-blind trial RU 41740 vs. placebo: immunological and clinical effects in a group of patients with chronic bronchitis.
A double-blind trail was performed to investigate the effects of RU 41740, a glycoprotein extract from Klebsiella pneumoniae, on host defenses and its efficacy in reducing the number of exacerbation in 29 evaluable patients with chronic bronchitis, out of 36 patients who entered the study. The drug enhanced the phagocytosis indexes of both polymorphonuclear and mononuclear phagocytes. Increased candidacidal activity of monocytes was also observed. These effects, already detectable after one course of therapy and during the entire period of treatment, were no longer detectable when tested 6 months after the end of treatment. A significantly (p less than 0.05) larger number of patients in the treated group than in the placebo group had no exacerbations during drug administration (0-3 months). Moreover, patients treated with RU 41740 had significantly fewer and shorter episodes of acute exacerbation. The positive decreases in these two parameters persisted throughout the follow-up.
Fietta
A
A
Department of Chemotherapy, University of Pavia, Italy.
Bersani
C
C
De Rose
V
V
Mangiarotti
P
P
Merlini
C
C
Uccelli
M
M
Guidi
G
G
Grassi
G G
GG
D000276:Adjuvants, Immunologic / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D001426:Bacterial Proteins / Q000627:therapeutic use*; D001991:Bronchitis / Q000188:drug therapy* / Q000276:immunology; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009000:Monocytes / Q000502:physiology; D009504:Neutrophils / Q000502:physiology; D010587:Phagocytosis / Q000187:drug effects; D011897:Random Allocation
D000276:Adjuvants, Immunologic; D001426:Bacterial Proteins; C037567:glycoprotein, Klebsiella pneumoniae