A new beclomethasone dipropionate multidose powder inhaler in the treatment of bronchial asthma.
The clinical efficacy, tolerability and acceptability of a new multidose powder inhaler (MDPI) containing beclomethasone dipropionate (BDP) were compared with those of a BDP aerosol administered with a large volume spacer (MDI-spacer) among adult asthmatics currently receiving from 500 to 1,000 microgram/day of an inhaled corticosteroid. During the study, the dosage of BDP from both devices was 400 microgram twice daily. Ninety-one patients were randomized to the MDPI group and 42 to the MDI-spacer group. The trial was performed as an open, randomized, parallel group multicenter study. The duration of the treatment period was 12 weeks, and the study was preceded by a 2-week run-in period. During the run-in period, the mean morning peak expiratory flow (PEF) was 487 and 466 1/min in the MDPI and MDI-spacer groups, respectively. After the 12-week treatment, the morning PEF was 491 1/min in the MDPI group and 463 1/min in the MDI-spacer group. The evening values were 500 and 479 1/min during the run-in period and 496 and 476 1/min after the 12-week treatment, respectively. Asthma symptom scores and the use of rescue medication were low in both groups, indicating good efficacy of the preparations tested. The median dose of histamine required to decrease forced expiratory volume in 1 s by 15% increased during the study from 800 to 1,098 microgram in the MDPI group and from 795 to 960 microgram in the MDI-spacer group. The most frequent adverse events in both groups were hoarseness and sore throat. There were no statistically significant differences between the treatment groups in serum cortisol values or in the number of patients with thrush. Seventy-two percent of the patients regarded the MDPI easier to use while 95% considered it more portable. Over 80% of the patients felt that the MDPI was also easier to clean and as easy or easier to learn to use than the MDI-spacer. To conclude, the novel powder inhaler is well tolerated and at least equally effective as the conventional MDI-spacer combination in the treatment of asthma with BDP. However, in everyday use, patients clearly favored the powder inhaler.
Nieminen
M M
MM
Department of Pulmonary Diseases, Tampere University Central Hospital, Tampere, Finland.
Vidgren
P
P
Kokkarinen
J
J
Laasonen
K
K
Liippo
K
K
Lindqvist
A
A
Paananen
M
M
Poukkula
A
A
Ruotsalainen
E
E
Salomaa
E
E
Sovijärvi
A
A
Söderblom
T
T
Silvasti
M
M
Vidgren
M
M
Laitinen
L A
LA
D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D000368:Aged; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage*; D001249:Asthma / Q000097:blood / Q000188:drug therapy*; D001507:Beclomethasone / Q000008:administration & dosage*; D016001:Confidence Intervals; D004305:Dose-Response Relationship, Drug; D005260:Female; D005387:Finland; D006801:Humans; D006854:Hydrocortisone / Q000097:blood; D008297:Male; D008875:Middle Aged; D009330:Nebulizers and Vaporizers; D010366:Peak Expiratory Flow Rate; D018709:Statistics, Nonparametric; D016896:Treatment Outcome
D018927:Anti-Asthmatic Agents; D001507:Beclomethasone; D006854:Hydrocortisone