Comparison of two beclomethasone dipropionate inhalation aerosol spacer combinations in the treatment of asthma.
Fifty-five asthmatics, previously treated with inhaled steroids (mean age 48 years, range 16-68 years, mean duration of the disease 10 years, range 1-35 years) participated in this multicentric 2-phase trial. The patients were in good clinical condition (basal FEV1 3.02 litres (1.38-6.29), 90% (48-131%) of predicted values; mean (range)). In the first phase (randomized, double-blind crossover study) 2 beclomethasone dipropionate (BDP) inhalation aerosol preparations (MDI) were administered through collapsible spacer. In the second phase (open, randomized, parallel group comparison), 1 of the preparations was administered via collapsible and the other via traditional large volume spacer. The total daily dose of inhaled beclomethasone was 1,000 micrograms. The evaluation of efficacy was based on peak flow monitoring (PEFR) carried out at home twice daily and on FEV1 measured in spirometry at control visits after the run-in period and after each 4-weeks treatment period. Side-effects and asthma symptoms were recorded on patient diaries. The patients were asked to evaluate the treatment efficacy and the use and handling of the MDI-spacer combinations with Visual Analog Scale (VAS) at the end of each treatment period. No statistically significant differences were found in PEFR or FEV1 between the treatments during whole study. The asthma symptom scores were low as well as the use of concomitant inhaled sympathomimetics which indicates good and equal efficacy of the preparations. The MDI-spacer combinations were equally well tolerated. According to the VAS scores, the collapsible spacer was easier to use and statistically significantly easier to handle than traditional large volume spacer.
Laurikainen
K
K
Medical Department, Orion-Farmos Pharmaceuticals, Kuopio, Finland.
Poukkula
A
A
Korhonen
P
P
Lehtonen
L
L
Vidgren
M
M
Silvasti
M
M
D000293:Adolescent; D000328:Adult; D000336:Aerosols; D000368:Aged; D001249:Asthma / Q000188:drug therapy*; D001507:Beclomethasone / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005079:Excipients; D005260:Female; D005541:Forced Expiratory Volume; D006801:Humans; D008297:Male; D008875:Middle Aged; D010366:Peak Expiratory Flow Rate
D000336:Aerosols; D005079:Excipients; D001507:Beclomethasone