Cardiovascular Diseases in Elderly Asthma

Asthma Clinical Trial

Official title:

Discovering Risk Factors for Cardiovascular Diseases in Elderly Asthma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03509259
• Other study ID #: L-2017-313
• Status: Active, not recruiting
• Start date: March 21, 2019
• Est. completion date: December 30, 2023

Study information

• Verified date: March 2021
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is a cross-sectional study to evaluate the relationship between coronary calcium score and clinical parameters of asthma such as onset of disease, lung function parameter and airway inflammation parameter (sputum eosinophil or FeNO) in Korean elderly asthma (regardless of whether they have concomittent COPD or not) patients

Description:

Subjects who visited Allergy Clinic in SMG-SNU Boramae Medical Center for asthma or ACO will be recruited consecutively. Subjects who meets the inclusion criteria and agree to participate in the study will take coronary artery calcium scoring CT and asthma CT (inspiration and expiration images). The correlation between the degree of coronary calcification and airway diameter, airway wall thickness, air-trapping and emphysema will be evaluated as well as clinical parameters of asthma. We will also compare those correlations from the images of healthy control subjects who performed the coronary calcium scoring CT for health checkup purpose.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 72
• Est. completion date: December 30, 2023
• Est. primary completion date: March 12, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• If the doctor has been diagnosed with asthma and one or more of the following criteria is met;

1. FEV1 increased more than 12% & 200 mL after 10-20 minutes of inhalation of short-acting bronchodilator (200-400 mg salbutamol)

2. Positive bronchial provocation tests (methacholine, mannitol, exercise, aspirin, etc.)

3. FEV1 Increased more than 12% & 200 mL from baseline FEV1 after anti-inflammatory treatment for 4 weeks or longer.

Exclusion Criteria:

• Those who were already diagnosed and treated for coronary artery diseases.

• Those with other structural lung diseases such as Tuberculosis destroyed lung and interstitial lung diseases

• Those who are unable to conduct a test or questionnaire due to severe systemic illness, or cognitive dysfunction.

• Those who are participating in other clinical trial using IND(investigational new drug) or finished other clinical trial within 30 days.

• Those who refuse to participate in the study or withdraw the consent.

Related Conditions & MeSH terms

• Asthma
• Cardiovascular Diseases

Locations

Country	Name	City	State
Korea, Republic of	SMG-SNU Boramae Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	SMG-SNU Boramae Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	coronary calcium score	coronary calcium score from coronary calcium scoring CT which, we assumed to be a surrogate marker for cardiovascular risk.	through study completion, an average of 1 month