Back to Search
Start Over
One-year efficacy and safety of inhaled formoterol dry powder in children with persistent asthma
- Source :
- Annals of Allergy, Asthma & Immunology. 89:180-190
- Publication Year :
- 2002
- Publisher :
- Elsevier BV, 2002.
-
Abstract
- The long-term efficacy and safety of formoterol dry powder capsules for inhalation in pediatric asthma have not previously been evaluated.We examined the effectiveness of inhaled formoterol over a period of 12 months in asthmatic children who were still symptomatic despite anti-inflammatory treatment.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.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 Por = 0.0062). Compared with placebo, both doses of formoterol significantly improved morning and evening premedication peak expiratory flow rate (all P0.001). 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.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.
- Subjects :
- Male
Pulmonary and Respiratory Medicine
Spirometry
Exacerbation
medicine.drug_class
Immunology
Anti-Inflammatory Agents
Peak Expiratory Flow Rate
Placebo
Double-Blind Method
Formoterol Fumarate
Bronchodilator
Administration, Inhalation
medicine
Humans
Immunology and Allergy
Albuterol
Child
Adrenergic beta-2 Receptor Agonists
Asthma
medicine.diagnostic_test
business.industry
Inhaler
Area under the curve
Adrenergic beta-Agonists
medicine.disease
Kinetics
Ethanolamines
Area Under Curve
Child, Preschool
Anesthesia
Drug Therapy, Combination
Female
Formoterol
Powders
business
medicine.drug
Subjects
Details
- ISSN :
- 10811206
- Volume :
- 89
- Database :
- OpenAIRE
- Journal :
- Annals of Allergy, Asthma & Immunology
- Accession number :
- edsair.doi.dedup.....58ca8447b643493af94472c3863b2cbc