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1.
Ann Allergy Asthma Immunol ; 85(5): 407-15, 2000 Nov.
Article in English | MEDLINE | ID: mdl-11101186

ABSTRACT

BACKGROUND: Flovent Diskus is a powder formulation of the inhaled corticosteroid fluticasone propionate (FP) delivered via a breath-actuated, multidose inhaler. OBJECTIVE: To determine the efficacy and safety of dry powder FP administered once or twice daily (200 microg per day) to children with persistent asthma. METHODS: Twelve-week, randomized, double-blind, placebo-controlled, multicenter trial with a 52-week, open-label extension. Children aged 4 to 11 were required to have pulmonary function 50% to 85% of predicted values. The population was stratified for baseline therapy (inhaled corticosteroid/cromolyn or bronchodilators only). After a 2-week placebo run-in, 242 patients received dry powder FP 200 microg each morning, dry powder FP 100 microg BID, or placebo for 12 weeks; 192 were rerandomized to the QD or BID regimen for an additional 52 weeks of open-label treatment. Primary endpoints were mean changes in FEV1 and morning PEF recorded at clinic visits. RESULTS: Both dry powder FP regimens significantly improved FEV1, evening PEF, and asthma symptoms at the double-blind phase endpoint (P < or = .017 compared with placebo). The BID regimen also significantly improved morning PEF and nighttime awakenings due to asthma (P < or = .005). Among patients previously treated with inhaled corticosteroids/cromolyn, improvements observed with the QD and BID regimens were similar. Patients switched from BID to open-label QD treatment showed additional improvements at week 52 generally comparable to patients who received the BID regimen during both phases. Fluticasone propionate was well tolerated for up to 64 weeks with few reports of drug-related adverse events or morning plasma cortisol abnormalities. CONCLUSIONS: Once daily dosing of dry powder FP 200 microg is an effective and convenient alternative for children whose asthma is controlled with a more frequent dosing regimen of inhaled corticosteroids.


Subject(s)
Androstadienes/pharmacokinetics , Androstadienes/therapeutic use , Anti-Asthmatic Agents/pharmacokinetics , Anti-Asthmatic Agents/therapeutic use , Asthma/drug therapy , Child , Child, Preschool , Double-Blind Method , Female , Fluticasone , Forced Expiratory Volume/drug effects , Humans , Male , Powders , Therapeutic Equivalency
2.
J Manipulative Physiol Ther ; 15(4): 250-4, 1992 May.
Article in English | MEDLINE | ID: mdl-1386101

ABSTRACT

Fracture of the vertebral ring apophysis in the lumbar spine is an uncommon condition that has been reported in adolescent patients presenting with low back pain. The pathophysiology is considered to be a fracture of the posterior ring apophysis in association with a herniated disc. The nature and the extension of the lesion is best established by computed tomography scan with sagittal reconstruction. We present three cases to illustrate the classic clinical and radiologic findings. Management of the condition is also discussed.


Subject(s)
Back Pain/etiology , Intervertebral Disc Displacement/complications , Lumbar Vertebrae/injuries , Spinal Fractures/complications , Adolescent , Child , Chiropractic/methods , Humans , Intervertebral Disc Displacement/diagnostic imaging , Intervertebral Disc Displacement/therapy , Laminectomy , Lumbar Vertebrae/diagnostic imaging , Male , Radiography , Spinal Fractures/diagnostic imaging , Spinal Fractures/therapy
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