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| Name | Class |
|---|---|
| The Third People's Hospital of Huizhou | OTHER |
| Guangdong Provincial Hospital of Traditional Chinese Medicine | OTHER |
| Nanfang Hospital, Southern Medical University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Foster treatment group | Experimental | Participant inhales Foster (Inhaled Beclometasone Dipropionate and Formoterol Inhalation Aerosol) 1 puff bid for 4 weeks. |
|
| Placebo controlled group | Placebo Comparator | Participant inhales matched placebo 1 puff bid for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beclometasone Dipropionate and Formoterol Inhalation Aerosol | Drug | Inhaled Foster (Beclometasone Dipropionate and Formoterol Inhalation Aerosol) , 1puff, BID, 4weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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%. | the 4th week |
| Measure | Description | Time Frame |
|---|---|---|
| Cough VAS change from baseline to the 4th week | The proportion of patients achieving a reduction of ≥30 mm in cough VAS score | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The AUC of blood eosinophils, FeNO in predicting the response to inhaled corticosteroid in patients with chronic cough. | The area under the receiver operating curve (AUC) of blood eosinophils in predicting the response to inhaled corticosteroid in patients with chronic cough. The area under the receiver operating curve (AUC) of FeNO in predicting the response to inhaled corticosteroid in patients with chronic cough. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kefang Lai, phD | The First Affiliated Hospital of Guangzhou Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | 520120 | China |
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| ID | Term |
|---|---|
| D003371 | Cough |
| D000096822 | Chronic Cough |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D001507 | Beclomethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Shenzhen People's Hospital |
| OTHER |
| SSL Central Hospital of Dongguan City | UNKNOWN |
| China-Japan Friendship Hospital | OTHER |
| Beijing Chao Yang Hospital | OTHER |
| Zunyi Medical College | OTHER |
| Henan Provincial People's Hospital | OTHER |
| The First Affiliated Hospital of Henan University of Traditional Chinese Medicine | OTHER |
| Second Hospital of Jilin University | OTHER |
| Inner Mongolia People's Hospital | OTHER |
| The First Affiliated Hospital of Shanxi Medical University | OTHER |
| Ruijin Hospital | OTHER |
| Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | OTHER |
| Tongji Hospital | OTHER |
| First Hospital of China Medical University | OTHER |
| Chongqing Songshan Hospital | UNKNOWN |
| The First People's Hospital of Yunnan | OTHER |
a multi-center, randomized, double-blind, placebo-controlled trial
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| Placebo | Drug | Inhaled Placebo, 1puff, BID, 4weeks |
|
| 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 | the 4th week |
| patient-reported global treatment response | patient-reported global treatment response (very effective, effective, partially effective or ineffective) | the 4th week |
| the 4th week |
| The optimal cut-off value of blood eosinophils in cells/μL-1 in predicting the response to inhaled corticosteroid in patients with chronic cough. | The optimal cut-off value of blood eosinophils in cells/μL-1 in predicting the response to inhaled corticosteroid in patients with chronic cough | the 4th week |
| The optimal cut-off value of FeNO in pbb in kU/L in predicting the response to inhaled corticosteroid in patients with chronic cough. | The optimal cut-off value of FeNO in pbb in predicting the response to inhaled corticosteroid in patients with chronic cough. | the 4th week |
| The sensitivity and specificity in percentage of blood eosinophils, FeNO and total IgE in predicting the response to inhaled corticosteroid in patients with chronic cough. | The sensitivity and specificity in percentage of blood eosinophils in predicting the response to inhaled corticosteroid in patients with chronic cough. The sensitivity and specificity in percentage of FeNO in predicting the response to inhaled corticosteroid in patients with chronic cough. The sensitivity and specificity in percentage of total IgE in predicting the response to inhaled corticosteroid in patients with chronic cough. | the 4th week |
| Clinical characteristics of responders and non-responders | Clinical characteristics including gender, age and cough duration would be registered in a specific case report form in baseline. | baseline |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013258 | Steroids, Chlorinated |