The Value of FeNO, Blood Eosinophils and TIgE in Predicting the Response to Corticosteroid in Patients With Chronic Cough
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 502
- Locations
- 1
- Primary Endpoint
- Cough VAS change from baseline to the 4th week
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Foster treatment group
Participant inhales Foster (Inhaled Beclometasone Dipropionate and Formoterol Inhalation Aerosol) 1 puff bid for 4 weeks.
Intervention: Beclometasone Dipropionate and Formoterol Inhalation Aerosol (Drug)
Placebo controlled group
Participant inhales matched placebo 1 puff bid for 4 weeks.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Cough VAS change from baseline to the 4th week
Time Frame: 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%.
Secondary Outcomes
- LCQ change from baseline to the 4th week(the 4th week)
- Cough VAS 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)
Investigators
Kefang Lai
professor
The First Affiliated Hospital of Guangzhou Medical University