This study evaluates the efficiency of ICS(budesonide) combined with LABA (formoterol) and LAMA(tiotropium) in the treatment of acute exacerbation of asthma-chronic obstructive pulmonary overlap. Half of participants will receive budesonide,formoterol and tiotropium in combination, while the other half will receive budesonide and formoterol only.
ACO(asthma-chronic obstructive pulmonary overlap) is a relatively new proposed clinical form of chronic airway disease. Guideline or preferring therapy for ACO is still evolving. Current clinical solution is when ACO presents like asthma, initial treatment will accord to the guideline for asthma , while it presents like COPD, COPD recommendation treatment (not alone ICS,but ICS in addition of LABA with or without LAMA) will be chosen, which are subjective. Although present guidelines has recommended that ACO should be treated with at last two inhalant, but limited date have proven it. A random controlled trial will be conducted to evaluate the efficiency of ICS(budesonide) combined with LABA (formoterol) and LAMA(tiotropium bromide) in the treatment of acute exacerbation of ACO,compared with the control group receiving tiotropium bromide with formoterol only.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
inhaled budesonide(160ug,bid),formotero(4.5ug,bid) and tiotropium bromide(18μg,qd)
inhaled formotero(4.5ug,bid) and tiotropium bromide(18μg,qd)
the frequency of ACO exacerbation
the frequency of ACO exacerbation
Time frame: 12 months
postbronchodilator FEV1
a post-bronchodilator forced expiratory volume in one second
Time frame: 12 months
times of hospital readmission caused by exacerbation
times of hospital readmission caused by exacerbation
Time frame: 12 months
other lung function parameters
other lung function parameters(%FEV1, FEV1/FVC)
Time frame: 12 months
CCQ score
Clinical COPD Questionnaire score
Time frame: 12 months
mMRC score
modified Medical Research Council score
Time frame: 12 months
CAT score
COPD Assessment Test score
Time frame: 12 months
ACT score
Asthma Control Test score
Time frame: 12 months
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