Efficacy and safety of budesonide inhalation powder (Pulmicort Turbuhaler) during 52 weeks of treatment in adults and children with persistent asthma.
BACKGROUND
Inhaled corticosteroids are the agents of choice for treating persistent asthma.


OBJECTIVE
To evaluate the long-term efficacy and safety of budesonide inhalation powder (Pulmicort Turbuhaler) in patients with mild to severe persistent asthma.


METHODS
Patients (n=1133) received open-label budesonide (dose range, 100-800 microg b.i.d.) for 52 weeks following 2 weeks to 5 months of treatment in one of four double-blind, placebo-controlled studies. Patients, identified before the double-blind studies, included adults (n=249) not receiving corticosteroids, adults (n=384) and children (n=356) previously maintained on inhaled corticosteroids, and adults (n=144) previously maintained on oral corticosteroids.


RESULTS
Mean forced expiratory volume in 1 sec was 68.2% of predicted normal (n=1133) at baseline (mean from two visits before randomization), 74.4% (n=1132) at the end of double-blind treatment, 81.3% (n=971) at week 52, and 80.1% (n=1125) at last observation (including patients who discontinued early). Sixty-four patients maintained on oral corticosteroids before double-blind treatment entered the open-label study off oral corticosteroids, 58 of whom (91%) remained oral corticosteroid-free throughout the study. There was no evidence of basal or cosyntropin-stimulated hypothalamic-pituitary-adrenal axis function suppression, and the most commonly occurring adverse events were respiratory infection, sinusitis, and pharyngitis.


CONCLUSIONS
During this 52-week, open-label study, budesonide maintained the improved pulmonary function and decreased oral corticosteroid use observed during previous double-blind treatment and was well tolerated, supporting its long-term use in adults and children with mild to severe persistent asthma.
Tinkelman
David G
DG
National Jewish Medical and Research Center, Denver, Colorado 80206, USA. tinkelmand@njc.org
Bronsky
Edwin A
EA
Gross
Gary
G
Schoenwetter
William F
WF
Spector
Sheldon L
SL
D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D001249:Asthma / Q000188:drug therapy*; D019819:Budesonide / Q000008:administration & dosage* / Q000627:therapeutic use; D002648:Child; D004311:Double-Blind Method; D005260:Female; D005541:Forced Expiratory Volume; D006801:Humans; D008297:Male; D009330:Nebulizers and Vaporizers; D011208:Powders; D013997:Time Factors
D000893:Anti-Inflammatory Agents; D011208:Powders; D019819:Budesonide