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

NCT05888350 | Completed

• 1 other identifier: CC-ICS
• Study Type: interventional
• Target: 502
• Locations: 1 country
• Sites: 1

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.

Conditions

Cough

Keywords

chronic cough; biomarkers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Cough VAS change from baseline to the 4th week

  the 4th week

• LCQ change from baseline to the 4th week

  the 4th week

• CET change from baseline at week 4

  the 4th week

• patient-reported global treatment response

  the 4th week

Other Outcomes (5)

• The AUC of blood eosinophils, 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 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 4th week

Study Arms (2)

Foster treatment group

EXPERIMENTAL

Participant inhales Foster (Inhaled Beclometasone Dipropionate and Formoterol Inhalation Aerosol) 1 puff bid for 4 weeks.

Drug: Beclometasone Dipropionate and Formoterol Inhalation Aerosol

Placebo controlled group

PLACEBO COMPARATOR

Participant inhales matched placebo 1 puff bid for 4 weeks.

Drug: Placebo

Interventions

Beclometasone Dipropionate and Formoterol Inhalation Aerosol DRUG

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

Foster treatment group

Placebo DRUG

Inhaled Placebo, 1puff, BID, 4weeks

Placebo controlled group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-70 years;
• Coughing lasting ≥ 8 weeks；
• 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)；
• FEV1% pred\>70%；FEV1/FVC\>70%；
• VAS≥30 in the past 48 hours;
• Non-smokers or patients smoked less than 10 pack-years;
• 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.

You may not qualify if:

• Patients received inhaled or oral corticosteroids or leukotriene receptor antagonist in previous 4 weeks;
• Patients with history of upper respiratory tract infection in the past 8 weeks;
• Patients taking angiotensin-converting enzyme inhibitors in previous 8 weeks;
• Female subjects who are pregnant, breast-feeding or risk of becoming pregnant during the study;
• 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;
• Participating in other drug clinical trial projects.

Sponsors & Collaborators

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

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 520120, China

Location

MeSH Terms

Conditions

Cough; Chronic Cough

Interventions

Beclomethasone

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated

Study Officials

• Kefang Lai, phD

  The First Affiliated Hospital of Guangzhou Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: a multi-center, randomized, double-blind, placebo-controlled trial

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: June 5, 2023
• Study Start: April 1, 2023
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)