Chronic CoughNCT06503939
Etiology Analysis of Chronic Cough After COVID-19 Infection and Research on the Efficacy of ICS or ICS/LABA
An observational study of Chronic Cough and Long COVID, run by Xiangya Hospital of Central South University at 1 site in China.
Trial summary
In this real-world study, we retrospectively classified the causes of chronic cough in patients, analyzed the prevalence of cough-variant asthma, and prospectively evaluated and compared the improvement of cough symptoms and quality of life after ICS/LABA or non-ICS/LABA treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Cough, Long COVID
- How many people
- 750 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 31 Dec 2024
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All persons who meet the above inclusion criteria and for whom no exclusion criteria exist
Who may be able to join
- Age ≥18 years old;
- A clear history of COVID-19 infection with a positive nucleic acid or antigen test before chronic cough;
- Persistent cough for more than 8 weeks after the acute phase of COVID-19 infection has disappeared;
- Chest X-ray and/or chest CT without significant evidence of lung disease;
- No history of chronic cough (>8 weeks) prior to COVID-19 infection.
Who cannot join
- The patient refused pulmonary function and blood tests;
- The patient has previously been diagnosed with respiratory diseases with cough as one of the main symptoms, including cough variant asthma, allergic bronchitis, eosinophilic bronchitis, gastroesophageal reflux disease, chronic obstructive pulmonary disease, chronic bronchitis, bronchiectasis, interstitial lung disease, pulmonary/tracheobronchial tuberculosis, etc.;
- Patients who are pregnant or breastfeeding;
- The patient's medical records are incomplete;
- Patients lost to follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
In this real-world study, we retrospectively classified the causes of chronic cough in patients, analyzed the prevalence of cough-variant asthma, and prospectively evaluated and compared the improvement of cough symptoms and quality of life after ICS/LABA or non-ICS/LABA treatment.
Read the detailed description
The subjects of this study were patients with chronic cough who were admitted to the Department of Respiratory and Critical Care Medicine, Xiangya Hospital, Central South University from March 1, 2023 to March 31, 2024. Patients are registered if they meet all of the following criteria: (1) ≥18 years of age; (2) A clear history of COVID-19 infection with a positive nucleic acid or antigen test before chronic cough;(3) Persistent cough for more than 8 weeks after the acute phase of COVID-19 infection has disappeared; (4) Chest X-ray and/or chest CT without significant evidence of lung disease; (5) No history of chronic cough (>8 weeks) prior to COVID-19 infection. Patients who met any of the following criteria were excluded: (1) Patients refused pulmonary function, blood tests; (2) The patient has previously been diagnosed with respiratory diseases with cough as one of the main symptoms, including cough variant asthma, allergic bronchitis, eosinophilic bronchitis, gastroesophageal reflux disease, chronic obstructive pulmonary disease, chronic bronchitis, bronchiectasis, interstitial lung disease, pulmonary/tracheobronchial tuberculosis, etc.; (3) Patients who are pregnant or breastfeeding; (4) The patient's medical records are incomplete; (5) Patients lost to follow-up. In the prospective part of this study, all enrolled patients with post-COVID chronic cough received pharmacotherapy as determined by the attending physicians (such as antitussive medications, ICS/LABA, montelukast, etc.), without protocol-driven modifications to treatment regimens. Baseline cough VAS and cough evaluation test (CET) scores were recorded. After one month of treatment, follow-up assessments of VAS and CET scores were conducted through either in-clinic visits or telemedicine.
- Conditions
- Chronic Cough, Long COVID
- Medical subject headings
- Chronic Cough, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CVA+ICS/LABA group | Patient who presented as chronic cough after COVID-19, were not diagnosed with CVA and received ICS/LABA treatment | |
| Non-CVA+ICS/LABA group | Patient who presented as chronic cough after COVID-19, were not diagnosed with CVA and received ICS/LABA treatment. | |
| Non-CVA+control group | Patient who presented as chronic cough after COVID-19, were not diagnosed with CVA and received treatment other than ICS/LABA. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of CVA
The precent of patients who met the diagnostic criteria of CVA among those presenting as chronic cough after SARS-CoV-2 infection
Measured: 2023.03-2023.11
ΔVAS
The change in cough VAS score from baseline to one-month post-treatment
Measured: 2023.06-2024.03
Secondary outcomes (1)
(ΔCET)
The secondary outcome was the changes in CET score from baseline to one-month post-treatment.
Measured: 2023.06-2024.03
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start1 Mar 2023
- Primary completion31 Mar 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic CoughStudies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juan Jiang, Doctor, Principal investigator, Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06503939
- Sponsor's protocol ID
- Z-2017-24-2301
- Status last verified
- Jul 2024
- First submitted
- 14 Jul 2024
- Last updated
- 22 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etiology Analysis of Chronic Cough After COVID-19 Infection and Research on the Efficacy of ICS or ICS/LABA
- ClinicalTrials.gov ID
- NCT06503939
- Acronym / sponsor ID
- Z-2017-24-2301
- Conditions
- Chronic Cough, Long COVID
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 16 Jul 2024 (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.
In this real-world study, we retrospectively classified the causes of chronic cough in patients, analyzed the prevalence of cough-variant asthma, and prospectively evaluated and compared the improvement of cough symptoms and quality of life after ICS/LABA or non-ICS/LABA treatment.
Detailed description
The subjects of this study were patients with chronic cough who were admitted to the Department of Respiratory and Critical Care Medicine, Xiangya Hospital, Central South University from March 1, 2023 to March 31, 2024. Patients are registered if they meet all of the following criteria: (1) ≥18 years of age; (2) A clear history of COVID-19 infection with a positive nucleic acid or antigen test before chronic cough;(3) Persistent cough for more than 8 weeks after the acute phase of COVID-19 infection has disappeared; (4) Chest X-ray and/or chest CT without significant evidence of lung disease; (5) No history of chronic cough (>8 weeks) prior to COVID-19 infection. Patients who met any of the following criteria were excluded: (1) Patients refused pulmonary function, blood tests; (2) The patient has previously been diagnosed with respiratory diseases with cough as one of the main symptoms, including cough variant asthma, allergic bronchitis, eosinophilic bronchitis, gastroesophageal reflux disease, chronic obstructive pulmonary disease, chronic bronchitis, bronchiectasis, interstitial lung disease, pulmonary/tracheobronchial tuberculosis, etc.; (3) Patients who are pregnant or breastfeeding; (4) The patient's medical records are incomplete; (5) Patients lost to follow-up. In the prospective part of this study, all enrolled patients with post-COVID chronic cough received pharmacotherapy as determined by the attending physicians (such as antitussive medications, ICS/LABA, montelukast, etc.), without protocol-driven modifications to treatment regimens. Baseline cough VAS and cough evaluation test (CET) scores were recorded. After one month of treatment, follow-up assessments of VAS and CET scores were conducted through either in-clinic visits or telemedicine.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CVA+ICS/LABA group | – | –Patient who presented as chronic cough after COVID-19, were not diagnosed with CVA and received ICS/LABA treatment |
| Non-CVA+ICS/LABA group | – | –Patient who presented as chronic cough after COVID-19, were not diagnosed with CVA and received ICS/LABA treatment. |
| Non-CVA+control group | – | –Patient who presented as chronic cough after COVID-19, were not diagnosed with CVA and received treatment other than ICS/LABA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All persons who meet the above inclusion criteria and for whom no exclusion criteria exist
Key inclusion criteria (5 listed)
- Age ≥18 years old;
- A clear history of COVID-19 infection with a positive nucleic acid or antigen test before chronic cough;
- Persistent cough for more than 8 weeks after the acute phase of COVID-19 infection has disappeared;
- Chest X-ray and/or chest CT without significant evidence of lung disease;
- No history of chronic cough (>8 weeks) prior to COVID-19 infection.
Key exclusion criteria (5 listed)
- The patient refused pulmonary function and blood tests;
- The patient has previously been diagnosed with respiratory diseases with cough as one of the main symptoms, including cough variant asthma, allergic bronchitis, eosinophilic bronchitis, gastroesophageal reflux disease, chronic obstructive pulmonary disease, chronic bronchitis, bronchiectasis, interstitial lung disease, pulmonary/tracheobronchial tuberculosis, etc.;
- Patients who are pregnant or breastfeeding;
- The patient's medical records are incomplete;
- Patients lost to follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The incidence of CVA
Time frame: 2023.03-2023.11
The precent of patients who met the diagnostic criteria of CVA among those presenting as chronic cough after SARS-CoV-2 infection
ΔVAS
Time frame: 2023.06-2024.03
The change in cough VAS score from baseline to one-month post-treatment
1 secondary outcome
(ΔCET)
Time frame: 2023.06-2024.03
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 22 Sep 2026.
- Individual participant dataSharing planned: Yes
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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.
Juan Jiang, Doctor principal investigator
Xiangya Hospital of Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Cough and Long COVID, run by Xiangya Hospital of Central South 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 5 inclusion and 5 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 22 Sep 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. 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?
The incidence of CVA (time frame: 2023.03-2023.11). The study lists 2 primary outcomes in all. 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 22 Sep 2026.