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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06199830
Other study ID # 2023-KLS-100-01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2022
Est. completion date August 31, 2023

Study information

Verified date December 2023
Source The First Affiliated Hospital of Zhejiang Chinese Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

this study aimed to compare characters in pulmonary function of patients with cough variant asthma and chronic cough and establish a diagnostic model.


Description:

the investigators retrospectively collected information from patients with chronic cough who underwent pulmonary tests at the First Affiliated Hospital of Zhejiang Chinese Medical University from January 2019 to December 2019. Data of external test were also from the First Affiliated Hospital of Zhejiang Chinese Medical University, and time period was from January 2023 to April 2023.Pulmonary function test and methacholine challenge test was performed by professional technicians. Characters between patients with cough variant asthma and chronic cough were compared to establish a diagnostic model.


Recruitment information / eligibility

Status Completed
Enrollment 645
Est. completion date August 31, 2023
Est. primary completion date May 20, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - (1) age from 18 years old to 65 years old; (2) clinical diagnosis of CVA and CC . Exclusion Criteria: - Exclusion criteria for CVA were: a history of COPD, bronchiectasis, bronchitis, cystic fibrosisor pneumonia, interstitial lung disease, pulmonary tuberculosis, lung cancer; cough caused by drugs or treatments; patients with upper airway cough syndromes (UACS) and gastroesophageal reflux-related cough (GERC) or other apparent causes of cough; patients who used corticosteroid (ICS) in the previous four weeks; Exclusion criteria for CC were: a history of variable airway limitation.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
positive bronchial provocation test
Patients were asked to inhale gradually increasing doses of methacholine (0.9% saline, 0.078, 0.312, 1.125 and 2.504 mg), and FEV1 was measured after each inhalation. This test was stopped until a reducing in baseline FEV1 of 20%.

Locations

Country Name City State
China The First Affiliated Hospital of Zhejiang Chinese Medical University Hangzhou

Sponsors (1)

Lead Sponsor Collaborator
The First Affiliated Hospital of Zhejiang Chinese Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary positive bronchial provocation test Patients were asked to inhale gradually increasing doses of methacholine (0.9% saline, 0.078, 0.312, 1.125 and 2.504 mg), and FEV1 was measured after each inhalation. This test was stopped until a reducing in baseline FEV1 of 20% up to 1 week
Secondary small airway dysfuction MMEF% pred, FEF50% pred, FEF75% pred up to 1 week
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