Clinical trial NCT06503939: Etiology Analysis of Chronic Cough After COVID-19 Infection and Research on the Efficacy of ICS or ICS/LABA
Official title: Etiology Analysis of Chronic Cough After COVID-19 Infection and Research on the Efficacy of ICS or ICS/LABA
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Chronic Cough
Keywords: COVID-19
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2024-07-16
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All persons who meet the above inclusion criteria and for whom no exclusion criteria exist

Brief summary: This study collected 600 patients, evaluated whether patients had airway hyperreactivity, airway inflammation, specific types and allergic reactions, comprehensively analyzed and classified the causes of chronic cough in patients, and evaluated and compared the improvement of cough symptoms and quality of life after ICS or 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 September 1, 2023 to December 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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years old;
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.

Exclusion Criteria:

1. The patient refused pulmonary function and 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.

Primary outcomes:
measure: The etiology of chronic cough was comprehensively analyzed and classified.
timeFrame: 2023.09-2024.12
Secondary outcomes:
measure: To evaluate and compare cough symptoms and quality of life improvement after ICS or ICS/LABA treatment.
timeFrame: 2023.09-2024.12
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
Study officials:
affiliation: Xiangya Hospital of Central South University
name: Juan Jiang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: