Biomarkers for Predicting the Response to Inhaled Corticosteroid in Patients With Chronic Cough.

Cough Clinical Trial

— CC-ICS  

Official title:

The Value of FeNO, Blood Eosinophils and TIgE in Predicting the Response to Corticosteroid in Patients With Chronic Cough

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05888350
• Other study ID #: CC-ICS
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 30, 2023
• Est. completion date: March 30, 2024

Study information

• Verified date: July 2023
• Source: The First Affiliated Hospital of Guangzhou Medical University
• Contact: Kefang Lai, phD
• Phone: 8156-6841
• Email: klai[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To investigate the value of blood eosinophils, FeNO and total IgE in predicting the response to inhaled corticosteroid in patients with chronic cough.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 520
• Est. completion date: March 30, 2024
• Est. primary completion date: March 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cough

Intervention

Drug:
• Beclometasone Dipropionate and Formoterol Inhalation Aerosol
Inhaled Foster (Beclometasone Dipropionate and Formoterol Inhalation Aerosol) , 1puff, BID, 4weeks
• Placebo
Inhaled Placebo, 1puff, BID, 4weeks

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (20)

Lead Sponsor

Collaborator

The First Affiliated Hospital of Guangzhou Medical University

Beijing Chao Yang Hospital, China-Japan Friendship Hospital, Chongqing Songshan Hospital, First Hospital of China Medical University, Guangdong Provincial Hospital of Traditional Chinese Medicine, Henan Provincial People's Hospital, Huizhou Third People's Hospital, Inner Mongolia People's Hospital, Nanfang Hospital, Southern Medical University, Ruijin Hospital, Second Hospital of Jilin University, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shenzhen People's Hospital, SSL Central Hospital of Dongguan City, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, The First Affiliated Hospital of Shanxi Medical University, The First People's Hospital of Yunnan, Tongji Hospital, Zunyi Medical College

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The AUC of blood eosinophils, FeNO and total IgE 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.; The area under the receiver operating curve (AUC) of total IgE in predicting the response to inhaled corticosteroid in patients with chronic cough.	the 4th week
Primary	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
Primary	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
Primary	The optimal cut-off value of total IgE in kU/L in predicting the response to inhaled corticosteroid in patients with chronic cough.	The optimal cut-off value of total IgE in kU/L in predicting the response to inhaled corticosteroid in patients with chronic cough.	the 4th week
Primary	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
Secondary	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
Secondary	LCQ change from baseline to the 4th week	Leicester Cough Questionnaire (LCQ)aims to access the life quality of patients wtih chronic cough, ranging from 19 to 133. Higher scores mean a better outcome.	the 4th week
Secondary	Cough VAS change from baseline to the 4th week	Cough visual analogue scale (VAS) aims to access the severity of cough, ranging from 0 to 100mm. Higher scores mean a worse outcome.	the 4th week