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NCT Number: NCT06503939

Etiology Analysis of Chronic Cough After COVID-19 Infection and Research on the Efficacy of ICS or ICS/LABA

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 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

  2. ΔVAS

    Time frame: 2023.06-2024.03

    The change in cough VAS score from baseline to one-month post-treatment

Secondary outcomes

  1. (ΔCET)

    Time frame: 2023.06-2024.03

    The secondary outcome was the changes in CET score from baseline to one-month post-treatment.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Xiangya Hospital of Central South University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 16, 2024
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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