Lung function and asthma control with beclomethasone and formoterol in a single inhaler.
BACKGROUND
Lung deposition is crucial for asthma treatment. However, there is no study comparing the potential role of lung co-deposition of combination therapy (inhaled corticosteroid and long-acting beta2 agonist) in the same inhaler. In moderate to severe asthmatics, an extra-fine hydrofluoroalkane combination of beclomethasone dipropionate and formoterol given via a single pressurised metered-dose inhaler (pMDI) was compared with beclomethasone dipropionate chlorofluorocarbon (CFC) pMDI and formoterol dry powder inhaler (DPI) given via separate inhalers.


METHODS
In a double-blind, double-dummy, 24-week randomised clinical trial, 645 patients with moderate to severe asthma uncontrolled by regular treatment with inhaled corticosteroids received regular treatment with extra-fine fixed combination beclomethasone dipropionate 200 microg/formoterol 12 microg bid, or beclomethasone dipropionate (500 microg bid) via CFC pMDI and formoterol (12 microg bid) via DPI, or beclomethasone dipropionate (500 microg bid) via CFC pMDI. The primary outcome was morning peak expiratory flow (PEF). Secondary outcomes included lung function measured at clinic, asthma symptoms and control, exacerbations.


RESULTS
Beclomethasone dipropionate/formoterol combination via single inhaler or via separate inhalers improved morning PEF. However, the combination via single inhaler was more effective than given via separate inhalers for asthma control. Both combination treatments were superior to beclomethasone dipropionate alone in improving lung function and asthma control. All treatments were well tolerated.


CONCLUSIONS
In patients with moderate to severe asthma, beclomethasone dipropionate/formoterol in a single inhaler was as effective as beclomethasone dipropionate plus formoterol and superior to beclomethasone dipropionate alone in improving lung function. For the first time with a single inhaler, beclomethasone dipropionate/formoterol was significantly superior to separate components for asthma control.
Huchon
G
G
Service de Pneumologie et Réanimation, Hôpital de l'Hôtel-Dieu, Paris, 1 Place du Parvis Notre Dame, 75181, Cedex 04, France.
Magnussen
H
H
Chuchalin
A
A
Dymek
L
L
Gonod
F Bonnet
FB
Bousquet
J
J
D000280:Administration, Inhalation; D000328:Adult; D000420:Albuterol / Q000627:therapeutic use; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D001249:Asthma / Q000097:blood / Q000188:drug therapy* / Q000503:physiopathology; D001507:Beclomethasone / Q000008:administration & dosage* / Q000627:therapeutic use; D001993:Bronchodilator Agents / Q000627:therapeutic use; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004338:Drug Combinations; D004983:Ethanolamines / Q000008:administration & dosage* / Q000627:therapeutic use; D005260:Female; D000068759:Formoterol Fumarate; D006801:Humans; D006854:Hydrocortisone / Q000097:blood; D008297:Male; D036501:Metered Dose Inhalers; D008875:Middle Aged; D010366:Peak Expiratory Flow Rate / Q000187:drug effects; D016896:Treatment Outcome
D018927:Anti-Asthmatic Agents; D001993:Bronchodilator Agents; D004338:Drug Combinations; D004983:Ethanolamines; D001507:Beclomethasone; D000420:Albuterol; D000068759:Formoterol Fumarate; D006854:Hydrocortisone