Back to resultsBiomarkers for Predicting the Response to Inhaled Corticosteroid in Patients With Chronic Cough. (CC-ICS)
Primary Purpose
Cough
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Beclometasone Dipropionate and Formoterol Inhalation Aerosol
Placebo
Sponsored by
About this trial
This is an interventional other trial for Cough focused on measuring chronic cough, biomarkers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Sites / Locations
- The First Affiliated Hospital of Guangzhou Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Foster treatment group
Placebo controlled group
Arm Description
Participant inhales Foster (Inhaled Beclometasone Dipropionate and Formoterol Inhalation Aerosol) 1 puff bid for 4 weeks.
Participant inhales matched placebo 1 puff bid for 4 weeks.
Outcomes
Primary Outcome Measures
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 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 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 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 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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT05888350
First Posted
March 27, 2023
Last Updated
July 10, 2023
Sponsor
The First Affiliated Hospital of Guangzhou Medical University
Collaborators
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
1. Study Identification
Unique Protocol Identification Number
NCT05888350
Brief Title
Biomarkers for Predicting the Response to Inhaled Corticosteroid in Patients With Chronic Cough.
Acronym
CC-ICS
Official Title
The Value of FeNO, Blood Eosinophils and TIgE in Predicting the Response to Corticosteroid in Patients With Chronic Cough
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 30, 2023 (Anticipated)
Primary Completion Date
March 2, 2024 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital of Guangzhou Medical University
Collaborators
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
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cough
Keywords
chronic cough, biomarkers
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
a multi-center, randomized, double-blind, placebo-controlled trial
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
520 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Foster treatment group
Arm Type
Experimental
Arm Description
Participant inhales Foster (Inhaled Beclometasone Dipropionate and Formoterol Inhalation Aerosol) 1 puff bid for 4 weeks.
Arm Title
Placebo controlled group
Arm Type
Placebo Comparator
Arm Description
Participant inhales matched placebo 1 puff bid for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Beclometasone Dipropionate and Formoterol Inhalation Aerosol
Intervention Description
Inhaled Foster (Beclometasone Dipropionate and Formoterol Inhalation Aerosol) , 1puff, BID, 4weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Inhaled Placebo, 1puff, BID, 4weeks
Primary Outcome Measure Information:
Title
The AUC of blood eosinophils, FeNO and total IgE in predicting the response to inhaled corticosteroid in patients with chronic cough.
Description
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.
Time Frame
the 4th week
Title
The optimal cut-off value of blood eosinophils in cells/μL-1 in predicting the response to inhaled corticosteroid in patients with chronic cough.
Description
The optimal cut-off value of blood eosinophils in cells/μL-1 in predicting the response to inhaled corticosteroid in patients with chronic cough.
Time Frame
the 4th week
Title
The optimal cut-off value of FeNO in pbb in kU/L in predicting the response to inhaled corticosteroid in patients with chronic cough.
Description
The optimal cut-off value of FeNO in pbb in predicting the response to inhaled corticosteroid in patients with chronic cough.
Time Frame
the 4th week
Title
The optimal cut-off value of total IgE in kU/L in predicting the response to inhaled corticosteroid in patients with chronic cough.
Description
The optimal cut-off value of total IgE in kU/L in predicting the response to inhaled corticosteroid in patients with chronic cough.
Time Frame
the 4th week
Title
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.
Description
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.
Time Frame
the 4th week
Secondary Outcome Measure Information:
Title
Clinical characteristics of responders and non-responders
Description
Clinical characteristics including gender, age and cough duration would be registered in a specific case report form in baseline.
Time Frame
baseline
Title
LCQ change from baseline to the 4th week
Description
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.
Time Frame
the 4th week
Title
Cough VAS change from baseline to the 4th week
Description
Cough visual analogue scale (VAS) aims to access the severity of cough, ranging from 0 to 100mm. Higher scores mean a worse outcome.
Time Frame
the 4th week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kefang Lai, phD
Phone
8156-6841
Ext
020
Email
klai@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kefang Lai, phD
Organizational Affiliation
The First Affiliated Hospital of Guangzhou Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
520120
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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Biomarkers for Predicting the Response to Inhaled Corticosteroid in Patients With Chronic Cough.
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