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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

520 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-30

Study Completion Date

2024-03-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Cough

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

a multi-center, randomized, double-blind, placebo-controlled trial

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Foster treatment group

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

Group Type EXPERIMENTAL

Beclometasone Dipropionate and Formoterol Inhalation Aerosol

Intervention Type DRUG

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

Placebo controlled group

Participant inhales matched placebo 1 puff bid for 4 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Inhaled Placebo, 1puff, BID, 4weeks

Interventions

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Beclometasone Dipropionate and Formoterol Inhalation Aerosol

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

Intervention Type DRUG

Placebo

Inhaled Placebo, 1puff, BID, 4weeks

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No