Effects of extra-fine inhaled beclomethasone/formoterol on both large and small airways in asthma.
BACKGROUND
Airway inflammation in asthma involves both large and small airways, and the combination of inhaled corticosteroids (ICS) and long acting beta-2 agonists (LABA) is the mainstay of therapy. Available inhaled combinations differ in terms of drug delivery to the lung and the ability to reach small airways.


OBJECTIVE
To evaluate whether treatment with an extra-fine inhaled combination provides additional effects vs a nonextra-fine combination on airway function.


METHODS
After a 1- to 4-week run-in period, patients with asthma were randomized to a double blind, double dummy, 12-week treatment with either extra-fine beclomethasone/formoterol (BDP/F) 400/24 microg daily or fluticasone propionate/salmeterol (FP/S) 500/100 microg daily. Methacholine (Mch) bronchoprovocation challenge and single breath nitrogen (sbN2) test were performed.


RESULTS
Thirty patients with asthma (15 men), mean age 43, mean forced expiratory volume in the first second (FEV(1)) 71.4% of predicted, were included. A significant increase (P < 0.01) versus baseline was observed in predose FEV(1) in both BDP/F and FP/S groups (0.37 +/- 0.13 l and 0.36 +/- 0.12 l, respectively). PD(20)FEV(1) Mch improved significantly from 90.42 (+/-30.08) microg to 432.41 (+/-122.71) microg in the BDP/F group (P = 0.01) but not in the FP/S group. A trend toward improvement vs baseline was observed for BDP/F in closing capacity (CC), whereas no differences were recorded in other sbN(2) test parameters.


CONCLUSIONS
The findings of this pilot study suggest that an extra-fine inhaled combination for the treatment of asthma has beneficial effects on both large and small airways function as expressed by Mch and sbN(2) tests.
Scichilone
N
N
Department of Medicine, Pneumology, Physiology and Human Nutrition (DIMPEFINU), University of Palermo, Palermo, Italy. n.scichilone@libero.it
Battaglia
S
S
Sorino
C
C
Paglino
G
G
Martino
L
L
Paternò
A
A
Santagata
R
R
Spatafora
M
M
Nicolini
G
G
Bellia
V
V
D000280:Administration, Inhalation; D000328:Adult; D000420:Albuterol / Q000031:analogs & derivatives / Q000627:therapeutic use; D000730:Androstadienes / Q000627:therapeutic use; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage*; D001249:Asthma / Q000188:drug therapy*; D001507:Beclomethasone / Q000008:administration & dosage*; D001980:Bronchi / Q000187:drug effects; D055745:Bronchioles / Q000187:drug effects; D002626:Chemistry, Pharmaceutical; D004311:Double-Blind Method; D004338:Drug Combinations; D004983:Ethanolamines / Q000008:administration & dosage*; D005260:Female; D000068297:Fluticasone-Salmeterol Drug Combination; D005541:Forced Expiratory Volume / Q000187:drug effects; D000068759:Formoterol Fumarate; D006801:Humans; D008297:Male; D036501:Metered Dose Inhalers; D010865:Pilot Projects; D012129:Respiratory Function Tests
D000730:Androstadienes; D018927:Anti-Asthmatic Agents; D004338:Drug Combinations; D004983:Ethanolamines; D000068297:Fluticasone-Salmeterol Drug Combination; D001507:Beclomethasone; D000420:Albuterol; D000068759:Formoterol Fumarate