Cough
Conditions
Keywords
chronic cough, biomarkers
Brief summary
To investigate the value of blood eosinophils, FeNO and total IgE in predicting the response to inhaled corticosteroid in patients with chronic cough.
Detailed description
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.
Interventions
DRUGPlacebo
Inhaled Placebo, 1puff, BID, 4weeks
Inhaled Foster (Beclometasone Dipropionate and Formoterol Inhalation Aerosol) , 1puff, BID, 4weeks
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Huizhou Third People's Hospital
Guangdong Provincial Hospital of Traditional Chinese Medicine
Nanfang Hospital, Southern Medical University
Shenzhen People's Hospital
SSL Central Hospital of Dongguan City
China-Japan Friendship Hospital
Beijing Chao Yang Hospital
Zunyi Medical College
Henan Provincial People's Hospital
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Second Hospital of Jilin University
Inner Mongolia People's Hospital
The First Affiliated Hospital of Shanxi Medical University
Ruijin Hospital
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Tongji Hospital
First Hospital of China Medical University
Chongqing Songshan Hospital
The First People's Hospital of Yunnan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Intervention model description
a multi-center, randomized, double-blind, placebo-controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Age: 18-70 years; 2. Coughing lasting ≥ 8 weeks； 3. No abnormality in chest imaging in the past 3 months (or there is abnormality but the investigator judges it not the cause of chronic cough)； 4. FEV1% pred\>70%；FEV1/FVC\>70%； 5. VAS≥30 in the past 48 hours; 6. Non-smokers or patients smoked less than 10 pack-years; 7. Candidates voluntarily participate in and abide by the relevant regulations of the study, can cooperate with corresponding inspections, follow the follow-up plan, and voluntarily sign written informed consent.
Exclusion criteria
1. Patients received inhaled or oral corticosteroids or leukotriene receptor antagonist in previous 4 weeks; 2. Patients with history of upper respiratory tract infection in the past 8 weeks; 3. Patients taking angiotensin-converting enzyme inhibitors in previous 8 weeks; 4. Female subjects who are pregnant, breast-feeding or risk of becoming pregnant during the study; 5. Combined with a definite history of pulmonary diseases such as bronchiectasis, pulmonary interstitial disease, and pulmonary hypertension. Combined with other serious diseases (such as cardiovascular system diseases, metabolic system diseases, immune system diseases, nervous system diseases, etc.) that may affect the normal process of this study; 6. Participating in other drug clinical trial projects.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cough VAS change from baseline to the 4th week | 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%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cough VAS change from baseline to the 4th week | the 4th week | The proportion of patients achieving a reduction of ≥30 mm in cough VAS score |
| LCQ change from baseline to the 4th week | 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 |
| CET change from baseline at week 4 | the 4th week | The percentage change in cough evaluation test (CET) from baseline at week 4; The proportion of patients achieving a reduction of ≥2 in CET |
| patient-reported global treatment response | the 4th week | patient-reported global treatment response (very effective, effective, partially effective or ineffective) |
Countries
China
Contacts
STUDY_CHAIRKefang Lai, phD
The First Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed