Use of formoterol dry powder administered for three months via a single-dose inhaler in 1,380 asthmatic patients.
Formoterol is a long-acting beta 2-adrenoceptor agonist available in a single-dose breath-actuated device (Foradil) for asthma treatment. Since efficacy and ease of use are key factors for compliance to therapy, the aim of this study was to assess correct use, efficacy and safety of Foradil in a 3-month, open, uncontrolled, multicenter trial. This study was performed on 1,380 patients with moderate or severe persistent asthma treated with inhaled corticosteroid (age: 48.4 +/- 16.2 years; FEV1: 65.4 +/- 19.4% of normal). During the study, compliance was over 90%. More than 90% of the patients used the inhaler correctly and found it easy or very easy to use. The mean increase in peak expiratory flow rate (PEFR), 30 to 60 min after inhalation, was 52.3 and 36.7 l/min for the morning and the evening respectively (p = 0.0001). This increase was already significant 5 min after inhalation, confirming the fast onset of action of formoterol. Mean predose PEFR and daytime/nocturnal symptom scores improved during the length of the study. Rescue short-acting beta 2-agonist consumption was more than three times reduced. At study completion, formoterol dosage was 12 micrograms and 24 micrograms twice daily for 71.5% and 28.5% of the patients respectively. Physicians judged the overall efficacy as good or very good in 87.1% of the patients, and they estimated the tolerability as very good or good in 92.6%. Drug-related adverse events were similar to those of other beta 2-agonists. In conclusion, this study demonstrated the ease of use of this formoterol single-dose dry powder inhaler, and confirmed the good efficacy and safety profile of this long-acting bronchodilator in asthma.
Clauzel
A M
AM
Respiratory Disease Clinic, Arnaud de Villeneuve Hospital, Montpellier, France.
Molimard
M
M
Le Gros
V
V
Lepère
E
E
Febvre
N
N
Michel
F B
FB
D000280:Administration, Inhalation; D000328:Adult; D018927:Anti-Asthmatic Agents / Q000627:therapeutic use; D001249:Asthma / Q000188:drug therapy*; D001993:Bronchodilator Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004983:Ethanolamines / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D000068759:Formoterol Fumarate; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D011208:Powders; D013997:Time Factors
D018927:Anti-Asthmatic Agents; D001993:Bronchodilator Agents; D004983:Ethanolamines; D011208:Powders; D000068759:Formoterol Fumarate