Biomarkers for Predicting the Response to Inhaled Corticosteroid in Patients With Chronic Cough. (CC-ICS)

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

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

Study Overview

• Status: Completed
• Conditions: Cough
• Intervention / Treatment: Drug: Beclometasone Dipropionate and Formoterol Inhalation Aerosol; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 502
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 520120
      • The First Affiliated Hospital of Guangzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Foster treatment group; Participant inhales Foster (Inhaled Beclometasone Dipropionate and Formoterol Inhalation Aerosol) 1 puff bid for 4 weeks.	Drug: Beclometasone Dipropionate and Formoterol Inhalation Aerosol; Inhaled Foster (Beclometasone Dipropionate and Formoterol Inhalation Aerosol) , 1puff, BID, 4weeks
Placebo Comparator: Placebo controlled group; Participant inhales matched placebo 1 puff bid for 4 weeks.	Drug: Placebo; Inhaled Placebo, 1puff, BID, 4weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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.	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 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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Actual): April 30, 2025
• Study Completion (Actual): April 30, 2025

Study Registration Dates

• First Submitted: March 27, 2023
• First Submitted That Met QC Criteria: June 2, 2023
• First Posted (Actual): June 5, 2023

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 14, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: biomarkers; chronic cough
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Cough; Cough; Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Pregnadienetriols; Steroids, Chlorinated; Beclomethasone
• Other Study ID Numbers: CC-ICS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No