Long-term safety and efficacy of budesonide nasal aerosol in perennial rhinitis. A 12-month multicentre study.
A long-term safety study of intranasally administered budesonide, a topical glucocorticoid, has been performed. 104 patients with perennial rhinitis, allergic or non-allergic, participated in a multicentre study in seven ENT-clinics utilising an identical protocol. A budesonide dosage of 400 micrograms/day was used as starting dose, but the patients were at liberty to reduce the daily dose to 200 micrograms. The patients were observed at intervals up to 12 months. At the entry and follow-up visits the following parameters were recorded: rhinoscopic findings, nasal symptom scores, blood chemistry, hematology, urinalysis and determination of plasma cortisol levels before and after stimulation with ACTH (Synacthen). Nasal biopsies taken from 50 of the patients at the beginning and completion of the study were examined in a blinded way by an independent pathologist. The analysis revealed no histopathological changes of the nasal mucosa. At rhinoscopy no signs of atrophy or candida were reported. Lividity of the nasal mucosa was significantly reduced during the trial, which was also the case for nasal congestion and secretion. All nasal symptom parameters assessed by the patients were significantly reduced from baseline during the follow-up period. No clinically significant changes in the hematological and blood chemistry parameters were observed. Plasma cortisol analysis before and after challenge with ACTH revealed no influence on the hypothalamic pituitary adrenal axis. No tachyphylaxis was observed; on the contrary, there was a clear tendency for reduction of the daily dose of budesonide necessary to keep the patients symptom-free.(ABSTRACT TRUNCATED AT 250 WORDS)
D000281:Administration, Intranasal; D000293:Adolescent; D000328:Adult; D000336:Aerosols; D000368:Aged; D019819:Budesonide; D002986:Clinical Trials as Topic; D003257:Consumer Product Safety; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011282:Pregnenediones / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use; D012221:Rhinitis, Allergic, Perennial / Q000188:drug therapy*
D000336:Aerosols; D011282:Pregnenediones; D019819:Budesonide