PMID- 12801318
OWN - NLM
STAT- MEDLINE
DCOM- 20030905
LR  - 20190901
IS  - 0954-7894 (Print)
IS  - 0954-7894 (Linking)
VI  - 33
IP  - 6
DP  - 2003 Jun
TI  - Safety of nasal budesonide in the long-term treatment of children with perennial 
      rhinitis.
PG  - 816-22
AB  - BACKGROUND: Intranasal budesonide is an efficacious treatment for perennial 
      allergic rhinitis. Long-term effects on safety, particularly in children, need 
      further investigation. OBJECTIVE: To investigate the long-term safety of 
      intranasal budesonide in children. METHODS: In an open trial, 78 children (5-15 
      years) with perennial rhinitis were treated with intranasal budesonide 
      pressurized metered dose inhaler 200 microg twice daily (delivered daily dose 256 
      microg) for 12 months; 43 children stayed in the study for 12 additional months 
      and were switched to aqueous suspension (400 microg delivered daily dose) for 6 
      months. Statural growth, bone age, ophthalmologic and rhinoscopic status, 
      cortisol and biochemical analyses in blood and urine were monitored during the 
      first and second years, and adverse events (AEs) were continuously recorded. 
      RESULTS: No significant effects on statural growth and bone age, compared with 
      reference values, were observed. Morning plasma cortisol and 24-h urinary 
      cortisol were not changed during treatment. Patients reported 195 AEs, most 
      commonly nasal dryness (30%), blood-tinged secretions (21%) and, among non-nasal 
      AEs, headache (13%). Rhinoscopy revealed no signs of mucosal atrophy, ulceration, 
      or candidiasis but some nasal dryness. No treatment-related ophthalmological or 
      biochemical aberrations were found. Reduction of blood eosinophils and nasal 
      symptom scores, compared with pre-treatment values, indicated the efficacy of 
      budesonide treatment. CONCLUSION: Long-term treatment for 1-2 years with 
      intranasal budesonide 256-400 microg daily in children with perennial rhinitis 
      revealed no negative effects on growth or endogenous cortisol production. Local 
      side-effects were mild and patient symptoms decreased.
FAU - Moller, C
AU  - Moller C
AD  - The Department of Paediatrics, University Hospital, Umea, Sweden. 
      christian.moller@nln.dL1.se
FAU - Ahlstrom, H
AU  - Ahlstrom H
FAU - Henricson, K-A
AU  - Henricson KA
FAU - Malmqvist, L-A
AU  - Malmqvist LA
FAU - Akerlund, A
AU  - Akerlund A
FAU - Hildebrand, H
AU  - Hildebrand H
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PL  - England
TA  - Clin Exp Allergy
JT  - Clinical and experimental allergy : journal of the British Society for Allergy 
      and Clinical Immunology
JID - 8906443
RN  - 0 (Glucocorticoids)
RN  - 51333-22-3 (Budesonide)
RN  - WI4X0X7BPJ (Hydrocortisone)
SB  - IM
MH  - Administration, Intranasal
MH  - Adolescent
MH  - Body Height/drug effects
MH  - Body Weight/drug effects
MH  - Bone Development/drug effects
MH  - Budesonide/*therapeutic use
MH  - Child
MH  - Child, Preschool
MH  - Female
MH  - Glucocorticoids/*therapeutic use
MH  - Humans
MH  - Hydrocortisone/blood/urine
MH  - Male
MH  - Rhinitis, Allergic, Perennial/*drug therapy
MH  - Time Factors
EDAT- 2003/06/13 05:00
MHDA- 2003/09/06 05:00
CRDT- 2003/06/13 05:00
PHST- 2003/06/13 05:00 [pubmed]
PHST- 2003/09/06 05:00 [medline]
PHST- 2003/06/13 05:00 [entrez]
AID - 1689 [pii]
AID - 10.1046/j.1365-2222.2003.01689.x [doi]
PST - ppublish
SO  - Clin Exp Allergy. 2003 Jun;33(6):816-22. doi: 10.1046/j.1365-2222.2003.01689.x.