CoughCC-ICSNCT05888350
Biomarkers for Predicting the Response to Inhaled Corticosteroid in Patients With Chronic Cough.
A study testing Beclometasone Dipropionate and Formoterol Inhalation Aerosol in people with Cough, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
To investigate the value of blood eosinophils, FeNO and total IgE in predicting the response to inhaled corticosteroid in patients with chronic cough. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cough
- What is being tested?
- Beclometasone Dipropionate and Formoterol Inhalation Aerosol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 502 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2023to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 520120
About this study
Official title: 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.
Read the 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.
- Conditions
- Cough
- Being tested
- Beclometasone Dipropionate and Formoterol Inhalation Aerosol, Placebo
- Keywords
- chronic cough, biomarkers
- Medical subject headings
- Cough, Chronic Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beclometasone Dipropionate and Formoterol Inhalation AerosolDrug
Inhaled Foster (Beclometasone Dipropionate and Formoterol Inhalation Aerosol) , 1puff, BID, 4weeks
PlaceboDrug
Inhaled Placebo, 1puff, BID, 4weeks
| Study group | Role | What they receive |
|---|---|---|
| Foster treatment group | Experimental | Participant inhales Foster (Inhaled Beclometasone Dipropionate and Formoterol Inhalation Aerosol) 1 puff bid for 4 weeks. Receives: Drug: Beclometasone Dipropionate and Formoterol Inhalation Aerosol |
| Placebo controlled group | Placebo comparator | Participant inhales matched placebo 1 puff bid for 4 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: the 4th week
Secondary outcomes (4)
Cough VAS change from baseline to the 4th week
The proportion of patients achieving a reduction of ≥30 mm in cough VAS score
Measured: 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
Measured: 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
Measured: the 4th week
patient-reported global treatment response
patient-reported global treatment response (very effective, effective, partially effective or ineffective)
Measured: the 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start1 Apr 2023
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoughStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Guangzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a multi-center, randomized, double-blind, placebo-controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 502 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The Third People's Hospital of Huizhou, 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
- Responsible party
- Principal investigator, Kefang Lai, The First Affiliated Hospital of Guangzhou Medical University
- Investigators
- Kefang Lai, phD, Study chair, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05888350
- Sponsor's protocol ID
- CC-ICS
- Acronym
- CC-ICS
- Status last verified
- Feb 2026
- First submitted
- 27 Mar 2023
- Last updated
- 18 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of FeNO, Blood Eosinophils and TIgE in Predicting the Response to Corticosteroid in Patients With Chronic Cough
- ClinicalTrials.gov ID
- NCT05888350
- Acronym / sponsor ID
- CC-ICS / CC-ICS
- Conditions
- Cough
- Keywords
- chronic cough, biomarkers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 502 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Collaborators
- The Third People's Hospital of Huizhou, 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
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 5 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- a multi-center, randomized, double-blind, placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Foster treatment group | Experimental | Drug: Beclometasone Dipropionate and Formoterol Inhalation AerosolParticipant inhales Foster (Inhaled Beclometasone Dipropionate and Formoterol Inhalation Aerosol) 1 puff bid for 4 weeks. |
| Placebo controlled group | Placebo comparator | Drug: PlaceboParticipant inhales matched placebo 1 puff bid for 4 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beclometasone Dipropionate and Formoterol Inhalation AerosolInhaled Foster (Beclometasone Dipropionate and Formoterol Inhalation Aerosol) , 1puff, BID, 4weeks | Drug | Foster treatment group |
| PlaceboInhaled Placebo, 1puff, BID, 4weeks | Drug | Placebo controlled group |
Primary outcome
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%.
4 secondary outcomes
Cough VAS change from baseline to the 4th week
Time frame: the 4th week
LCQ change from baseline to the 4th week
Time frame: the 4th week
CET change from baseline at week 4
Time frame: the 4th week
patient-reported global treatment response
Time frame: the 4th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kefang Lai, phD study chair
The First Affiliated Hospital of Guangzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beclometasone Dipropionate and Formoterol Inhalation Aerosol in people with Cough, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cough VAS change from baseline to the 4th week (time frame: the 4th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.