A Case-control Study on the Differentiation Between Cough Variant Asthma and Chronic Cough

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

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Diagnostic test: positive bronchial provocation test

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 645

Contacts and Locations

Study Locations

• China
  • Hangzhou, China
    • The First Affiliated Hospital of Zhejiang Chinese Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

We retrospectively collected information from patients with CC who underwent pulmonary tests at the First Affiliated Hospital of Zhejiang Chinese Medical University from January 2019 to December 2019.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
cough variant asthma; (1) chronic cough (≥8 weeks) as the sore or predominant symptom; (2) variable airway limitation evaluated by BHR test; (3) a positive response to anti-asthma therapy; (4) No other causes of chronic cough.	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%.
chronic cough; (1) chronic cough (≥8 weeks) as the sore or predominant symptom; (2) without radiographic evidence of lung disease; (3) with no fever, blood-stained sputum or other active respiratory injection;

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
small airway dysfuction	MMEF% pred, FEF50% pred, FEF75% pred	up to 1 week

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Zhejiang Chinese Medical University
• Investigators: Principal Investigator: Junchao Yang, Dr, The First Affiliated Hospital of Zhejiang Chinese Medical University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): May 20, 2023
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: October 20, 2023
• First Submitted That Met QC Criteria: December 28, 2023
• First Posted (Actual): January 10, 2024

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 9, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Chronic cough; cough variant asthma; small airway dysfunction
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Respiration Disorders; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Signs and Symptoms, Respiratory; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Cough; Chronic Cough; Cough-Variant Asthma
• Other Study ID Numbers: 2023-KLS-100-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No