NCT06503939

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 16, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

July 16, 2024

Status Verified

July 1, 2024

Enrollment Period

1.3 years

First QC Date

July 14, 2024

Last Update Submit

July 14, 2024

Conditions

Keywords

COVID-19

Outcome Measures

Primary Outcomes (1)

  • The etiology of chronic cough was comprehensively analyzed and classified.

    2023.09-2024.12

Secondary Outcomes (1)

  • To evaluate and compare cough symptoms and quality of life improvement after ICS or ICS/LABA treatment.

    2023.09-2024.12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All persons who meet the above inclusion criteria and for whom no exclusion criteria exist

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xiangya Hospital Central South University

Changsha, Hunan, 410008, China

Location

MeSH Terms

Conditions

Chronic CoughCOVID-19

Condition Hierarchy (Ancestors)

CoughRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung Diseases

Study Officials

  • Juan Jiang, Doctor

    Xiangya Hospital of Central South University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2024

First Posted

July 16, 2024

Study Start

September 1, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

July 16, 2024

Record last verified: 2024-07

Locations