Double-blind, placebo-controlled immunotherapy with mixed grass-pollen allergoids. IV. Comparison of the safety and efficacy of two dosages of a high-molecular-weight allergoid.
Specific immunotherapy is still widely used in grass-pollen allergy, but its side effects may limit its use. We tested the safety and efficacy of a formalinized high-molecular-weight allergoid prepared from a mixed grass-pollen extract with two injection schedules in a double-blind, placebo-controlled study. Eighteen patients received placebo, 19 received the low-dose schedule (maximal dose: 2000 PNU) and 20 received the high-dose schedule (maximal dose: 10,000 PNU). Only one patient presented a systemic reaction of moderate severity for a dose of 1200 PNU. Before the onset of the pollen season, patients had a nasal challenge with orchard grass-pollen grains, a skin test titration, and the titration of serum-specific IgG. Both groups of patients presented a significant reduction in nasal and skin sensitivities and a significant increase in IgG compared to placebo. Symptoms and medications for rhinitis and asthma were studied during the season, and both groups receiving allergoids had a significant reduction of symptom-medication scores for nasal and bronchial symptoms. There was a highly significant correlation between nasal symptom-medication scores during the season and the results of nasal challenges. High-molecular-weight allergoids are safe and effective.
Bousquet
J
J
Clinique des Maladies Respiratoires, CHU, Hopital l'Aiguelongue, Montpellier, France.
Hejjaoui
A
A
Soussana
M
M
Michel
F B
FB
D000293:Adolescent; D000328:Adult; D000485:Allergens / Q000008:administration & dosage* / Q000009:adverse effects; D002648:Child; D002986:Clinical Trials as Topic; D004306:Dose-Response Relationship, Immunologic; D004311:Double-Blind Method; D006801:Humans; D007074:Immunoglobulin G / Q000032:analysis; D007167:Immunotherapy / Q000009:adverse effects / Q000379:methods*; D008297:Male; D008970:Molecular Weight; D009299:Nasal Provocation Tests; D010919:Placebos; D011058:Pollen / Q000276:immunology*; D006255:Rhinitis, Allergic, Seasonal / Q000276:immunology / Q000628:therapy; D012882:Skin Tests
D000485:Allergens; D007074:Immunoglobulin G; D010919:Placebos