Clinical trial NCT05888350: Biomarkers for Predicting the Response to Inhaled Corticosteroid in Patients With Chronic Cough.
Official title: The Value of FeNO, Blood Eosinophils and TIgE in Predicting the Response to Corticosteroid in Patients With Chronic Cough
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cough
Keywords: chronic cough
biomarkers
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
Collaborators: name: Huizhou Third People's Hospital
name: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: Nanfang Hospital, Southern Medical University
name: Shenzhen People's Hospital
name: SSL Central Hospital of Dongguan City
name: China-Japan Friendship Hospital
name: Beijing Chao Yang Hospital
name: Zunyi Medical College
name: Henan Provincial People's Hospital
name: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
name: Second Hospital of Jilin University
name: Inner Mongolia People's Hospital
name: The First Affiliated Hospital of Shanxi Medical University
name: Ruijin Hospital
name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Tongji Hospital
name: First Hospital of China Medical University
name: Chongqing Songshan Hospital
name: The First People's Hospital of Yunnan
First posted: 2023-06-05
Enrollment: 520
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a multi-center, randomized, double-blind, placebo-controlled trial
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The AUC of blood eosinophils, FeNO and total IgE in predicting the response to inhaled corticosteroid in patients with chronic cough.
timeFrame: the 4th week
measure: The optimal cut-off value of blood eosinophils in cells/μL-1 in predicting the response to inhaled corticosteroid in patients with chronic cough.
timeFrame: the 4th week
measure: The optimal cut-off value of FeNO in pbb in kU/L in predicting the response to inhaled corticosteroid in patients with chronic cough.
timeFrame: the 4th week
measure: The optimal cut-off value of total IgE in kU/L in predicting the response to inhaled corticosteroid in patients with chronic cough.
timeFrame: the 4th week
measure: 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.
timeFrame: the 4th week
Secondary outcomes:
measure: Clinical characteristics of responders and non-responders
timeFrame: baseline
measure: LCQ change from baseline to the 4th week
timeFrame: the 4th week
measure: Cough VAS change from baseline to the 4th week
timeFrame: the 4th week
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
affiliation: The First Affiliated Hospital of Guangzhou Medical University
name: Kefang Lai, phD
role: STUDY_CHAIR
References: