To investigate the value of blood eosinophils, FeNO and total IgE in predicting the response to inhaled corticosteroid in patients with chronic cough.
Chronic cough is a frequent complaint in respiratory specialists clinic. CVA, UACS, EB, GERC and AC are common causes of chronic cough, among whom, CVA, EB and AC can be classified as corticosteroid responsive cough. To recognize the eosinophilic airway inflammation and assess the response of inhaled corticosteroid, induced sputum analysis is the most widely used examination but not all the subjects can provide an suitable sample of sputum for measurements and it's time-consuming. Recently, blood eosinophils, FeNO and total IgE were detected to be biomarkers of eosinophilic airway inflammation for asthmatics. However, whether can they predict the response to corticosteroid in chronic cough remains uncertain. The present prospective, multi-center, randomized placebo-controlled study aims to explore the value of blood eosinophils, FeNO and total IgE in predicting the response to inhaled corticosteroid in patients with chronic cough.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
502
Inhaled Foster (Beclometasone Dipropionate and Formoterol Inhalation Aerosol) , 1puff, BID, 4weeks
Inhaled Placebo, 1puff, BID, 4weeks
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Cough VAS change from baseline to the 4th week
the percentage change in cough VAS score from baseline at week 4, calculated as (VAS baseline-VAS week 4) / VAS baseline×100%.
Time frame: the 4th week
Cough VAS change from baseline to the 4th week
The proportion of patients achieving a reduction of ≥30 mm in cough VAS score
Time frame: the 4th week
LCQ change from baseline to the 4th week
The percentage change in Leicester cough questionnaire (LCQ) and cough evaluation test (CET) from baseline at week 4. The proportion of patients achieving an improvement of ≥1.3 in LCQ score
Time frame: the 4th week
CET change from baseline at week 4
The percentage change in cough evaluation test (CET) from baseline at week 4; The proportion of patients achieving a reduction of ≥2 in CET
Time frame: the 4th week
patient-reported global treatment response
patient-reported global treatment response (very effective, effective, partially effective or ineffective)
Time frame: the 4th week
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