PMID- 16432294
OWN - NLM
STAT- MEDLINE
DCOM- 20061114
LR  - 20151119
IS  - 0025-7931 (Print)
IS  - 0025-7931 (Linking)
VI  - 73
IP  - 4
DP  - 2006
TI  - Clinically equivalent bronchodilatation achieved with formoterol delivered via 
      Easyhaler and Aerolizer.
PG  - 441-8
AB  - BACKGROUND: User-friendly devices for the delivery of asthma drugs are needed to 
      enhance treatment compliance. Formoterol inhalation powder has been developed to 
      Easyhaler multidose powder inhaler to enable the treatment of all asthma 
      severities with the same device. OBJECTIVES: This double-blind, double-dummy, 
      single- dose, placebo-controlled, cross-over study aimed to demonstrate the 
      non-inferiority of the bronchodilating effect of formoterol 12 microg delivered 
      via Easyhaler versus via Aerolizer. In addition, dose responses following 
      placebo, 12-microg and 48-microg doses of formoterol via Easyhaler were compared. 
      Furthermore, onset and duration of action, and safety of formoterol inhaled using 
      the two inhalers were compared. METHODS: Sixty-seven adult asthmatic subjects 
      showing >or=15% increase in forced expiratory volume in 1 s (FEV(1)) after 
      short-acting sympathomimetic inhalation were enrolled and completed the study. 
      The study comprised screening and 4 treatment days, with each subject inhaling a 
      single 12-mug dose of formoterol via Easyhaler, a 12-microg dose via Aerolizer, a 
      48-microg dose via Easyhaler or placebo. Repeat spirometry and vital sign 
      measurements were performed for 12 h during treatment days. The primary efficacy 
      variable was the area under the flow volume curve (AUC(0-12)) of FEV(1). 
      Secondary efficacy variables comprised maximum FEV(1 )(FEV(1max)), forced vital 
      capacity (FVC), and the need of rescue medication during the treatment days. 
      Safety was evaluated by determining blood pressure, heart rate and the number of 
      adverse events (AEs). RESULTS: Results showed the non-inferiority of the 
      bronchodilating effect of 12 microg formoterol via Easyhaler compared to 
      Aerolizer. The Easyhaler-Aerolizer ratio for AUC(0-12) of FEV(1 )was 0.991 (95% 
      confidence interval from 0.969 to 1.013). No statistically significant 
      differences emerged for secondary efficacy variables. A statistically significant 
      dose response was seen following placebo, 12- and 48-microg doses in FEV(1). No 
      safety differences emerged for the 12-microg dose inhaled via Easyhaler or 
      Aerolizer, but the incidence of AEs was higher following formoterol 48 microg and 
      placebo treatments. CONCLUSIONS: Formoterol delivered via Easyhaler was 
      therapeutically equivalent to Aerolizerat the 12-microg dose. The 48-microg dose 
      via Easyhaler demonstrated statistically significantly greater bronchodilation 
      but showed an increased occurrence of AEs.
FAU - Dubakiene, Ruta
AU  - Dubakiene R
AD  - Vilnius University Antakalnis Hospital, Allergy Centre, Vilnius, Lithuania, 
      Finland.
FAU - Nargela, Remigijus
AU  - Nargela R
FAU - Sakalauskas, Raimundas
AU  - Sakalauskas R
FAU - Vahteristo, Mikko
AU  - Vahteristo M
FAU - Silvasti, Matti
AU  - Silvasti M
FAU - Lahelma, Satu
AU  - Lahelma S
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20051007
PL  - Switzerland
TA  - Respiration
JT  - Respiration; international review of thoracic diseases
JID - 0137356
RN  - 0 (Bronchodilator Agents)
RN  - 0 (Ethanolamines)
RN  - 0 (Placebos)
RN  - W34SHF8J2K (Formoterol Fumarate)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Asthma/*drug therapy
MH  - Bronchodilator Agents/administration & dosage/therapeutic use
MH  - Cross-Over Studies
MH  - Equipment Design
MH  - Ethanolamines/*administration & dosage/therapeutic use
MH  - Forced Expiratory Volume
MH  - Formoterol Fumarate
MH  - Humans
MH  - Middle Aged
MH  - *Nebulizers and Vaporizers
MH  - Placebos
EDAT- 2006/01/25 09:00
MHDA- 2006/11/15 09:00
CRDT- 2006/01/25 09:00
PHST- 2005/04/12 00:00 [received]
PHST- 2005/07/13 00:00 [accepted]
PHST- 2006/01/25 09:00 [pubmed]
PHST- 2006/11/15 09:00 [medline]
PHST- 2006/01/25 09:00 [entrez]
AID - 000088896 [pii]
AID - 10.1159/000088896 [doi]
PST - ppublish
SO  - Respiration. 2006;73(4):441-8. doi: 10.1159/000088896. Epub 2005 Oct 7.