One-year efficacy and safety of inhaled formoterol dry powder in children with persistent asthma.
BACKGROUND
The long-term efficacy and safety of formoterol dry powder capsules for inhalation in pediatric asthma have not previously been evaluated.


OBJECTIVE
We examined the effectiveness of inhaled formoterol over a period of 12 months in asthmatic children who were still symptomatic despite anti-inflammatory treatment.


METHODS
After a run-in period, 518 patients (5 to 12 years old) were randomized in a double-blind manner to receive 12 or 24 microg formoterol dry powder (Foradil, Novartis Pharma AG, Basel, Switzerland) or placebo twice daily for 12 months. The drug was administered by inhaler (Aerolizer, Novartis Pharma AG) and was given in addition to their anti-inflammatory treatment. The primary variable was the area under the curve for forced expiratory volume in 1 second measured over 12 hours after the morning dose of study medication.


RESULTS
The area under the curve for forced expiratory volume in 1 second after the first dose of treatment and after 3 and 12 months of treatment was significantly greater for patients receiving formoterol 12 microg and 24 microg than for patients receiving placebo (all P < or = 0.0062). Compared with placebo, both doses of formoterol significantly improved morning and evening premedication peak expiratory flow rate (all P < 0.001). In the group treated with formoterol 24 microg, median symptom score and median dose of rescue medication at night were lower than during the run-in period, whereas the opposite occurred in the placebo group. The incidence of hospitalizations for asthma was higher in the formoterol groups than in the placebo group.


CONCLUSIONS
Our results indicate that, in asthmatic children who are still symptomatic despite anti-inflammatory therapy, the addition of formoterol consistently improves airflow obstruction and nocturnal symptoms and reduces the use of rescue medication. However, this treatment requires close disease monitoring to detect early signs of acute exacerbation.
Bensch
George
G
Georgetown Place, Stockton, California, USA.
Berger
William E
WE
Blokhin
Boris M
BM
Socolovsky
Aron L
AL
Thomson
Moira H
MH
Till
M Denise
MD
Castellsague
Jordi
J
Della Cioppa
Giovanni
G
D000280:Administration, Inhalation; D058666:Adrenergic beta-2 Receptor Agonists; D000318:Adrenergic beta-Agonists / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D000420:Albuterol / Q000627:therapeutic use; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use; D019540:Area Under Curve; D001249:Asthma / Q000175:diagnosis / Q000188:drug therapy*; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004983:Ethanolamines / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D005260:Female; D000068759:Formoterol Fumarate; D006801:Humans; D007700:Kinetics; D008297:Male; D010366:Peak Expiratory Flow Rate; D011208:Powders; D013147:Spirometry
D058666:Adrenergic beta-2 Receptor Agonists; D000318:Adrenergic beta-Agonists; D000893:Anti-Inflammatory Agents; D004983:Ethanolamines; D011208:Powders; D000420:Albuterol; D000068759:Formoterol Fumarate