Inhaled beclomethasone dipropionate administered through a new spacer device: a controlled clinical study.
This 4-week, randomized, parallel-group study compared the efficacy and safety of a metered-dose inhaler equipped with a new spacer device (Jet spacer) with those of a standard actuator in the administration of inhaled beclomethasone dipropionate (0.5 mg twice daily) in 66 adults with chronic obstructive pulmonary disease (COPD) who were responsive to beta 2-agonists. Lung function values, symptom scores, and daily consumption of a beta 2-agonist determined efficacy. At baseline and after treatment, levels of morning serum and 24-hour urinary cortisol were measured in half of the patients (one center). Ease of use of the two devices was expressed by patients at the final visit. Lung function values and clinical symptoms improved in both groups (P < .01 at the final visit); the Jet group reported a better outcome (P < .05 between groups) than the standard-actuator group for predicted normal values of forced expiratory volume in 1 second, forced vital capacity, and bronchial noises. Salbutamol consumption decreased in both groups. One patient in the Jet group and 5 patients in the standard-actuator group reported adverse reactions. No significant between-group differences were found in plasma and urinary cortisol levels. The Jet device was judged easier to use (P < .05 between groups) than the standard actuator. In conclusion, the jet device was more effective than a standard actuator in reducing local adverse reactions to inhaled beclomethasone dipropionate in adults with COPD, with a better efficacy profile.
Vecchiet
L
L
Institute of Medical Semiotics, University of Chieti, Italy.
Pieralisi
G
G
Ambrosi
L
L
Di Lorenzo
L
L
Cantini
L
L
D000293:Adolescent; D000319:Adrenergic beta-Antagonists / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001507:Beclomethasone / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D006854:Hydrocortisone / Q000032:analysis; D008173:Lung Diseases, Obstructive / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D012129:Respiratory Function Tests; D012138:Respiratory Therapy / Q000295:instrumentation*