Elsevier

Respiratory Medicine

Volume 103, Issue 1, January 2009, Pages 41-49
Respiratory Medicine

Lung function and asthma control with beclomethasone and formoterol in a single inhaler

https://doi.org/10.1016/j.rmed.2008.09.002Get rights and content
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Summary

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 β2 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 μg/formoterol 12 μg bid, or beclomethasone dipropionate (500 μg bid) via CFC pMDI and formoterol (12 μg bid) via DPI, or beclomethasone dipropionate (500 μg 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.

Interpretation

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. This trial is registered withClinicalTrials.gov, number NCT00476268.

Keywords

Corticosteroid
Airway inflammation
Long-acting β2 agonist
Hydrofluoroalkane
Combination therapy
Extra-fine

List of abbreviations

ACTH
adrenocorticotropic hormone
ANCOVA
analysis of covariance
CI
confidence interval
CFC
chlorofluorocarbon
DPI
dry powder inhaler
ECG
electrocardiogram
FEF25–75%
forced expiratory flow between 25% and 75% of FVC
FEV1
forced expiratory volume in one second
FVC
forced vital capacity
GINA
global initiative for asthma
HFA
hydrofluoroalkane
ITT
intention to treat
LSM
least squares mean
MDI
metered-dose inhaler
PEF
peak expiratory flow
pMDI
pressurised metered-dose inhaler
PP
per protocol
SD
standard deviation
SE
standard error

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Member of GA2LEN, supported by EU Framework programme for research, contract no FOOD-CT-2004-506378.