The purpose of this study is to determine whether extra fine formoterol/beclomethasona are more effective in the treatment of asthmatic crisis when added to conventional treatment compared with conventional treatment alone.
Inhaled corticosteroids still the cornerstone in treatment of stable asthma, while bronchodilators and systemic steroids are in asthmatic crisis. Asthmatic exacerbations are events occurring in the natural course of the disease, require a change in actual medication and they are associated with risks of complications producing important economic costs. Some is known about non-genomic effects of inhaled corticosteroids, making possible, at least in theory, having a positive effect on treatment of a crisis. On the other hand, formoterol has been shown to have a rapid beginning of action (3 minutes), persisting its effect during 12 hours and it has been shown to be as effective as albuterol in the treatment of a crisis. The development of extra-fine particles has allowed reaching more distal zones in the lungs producing more deposition of the drug, which as well decrease adverse effects are lesser doses of the drug are needed. According to that, aims of this work is to determine whether extra-fine formoterol/beclomethasona are more effective in the treatment of asthmatic crisis when added to conventional treatment compared with conventional treatment in terms of pulmonary function, symptoms, inflammation markers and rates of hospitalization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
standard treatment consisting in: Albuterol 2.5 mg via nebulizer at baseline (0), 20, 40 minutes + Systemic steroid (methylprednisolone 60 mg) at the moment of evaluation \+ formoterol/beclomethasone, 3 puffs administered via aerochamber at baseline (0), 20, 40, 60 minutes
National Institute of Respiratory Diseases
Mexico City, Mexico City, Mexico
Pulmonary Function
change in Forced Expiratory Volume in 1 second (FEV1) with respect to basal
Time frame: 120 minutes
Need for hospitalization
Time frame: 120 minutes
Change in perception of dyspnea
change in Borg and Transitional Dyspnea Index
Time frame: 90 minutes
Biomarkers of inflammation
change in C- reactive protein, TNF-alpha, eosinophils
Time frame: 120 minutes
interleukins
change in eosinophilic and non eosinophilic interleukins (IL-4, IL-5, IL-13, IL-17, IL-33)
Time frame: 120 min
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