Impact of COVID19 on Asthma

Asthma Clinical Trial

— IMCAS proyect  

Official title:

Impact of COVID19 on Lung Function and Control of Asthma Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05064501
• Other study ID #: IIBSP-COV-2020-129
• Status: Recruiting
• Start date: February 1, 2021
• Est. completion date: June 1, 2024

Study information

• Verified date: August 2022
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: Elena Curto, MD
• Phone: 699877357
• Email: ecurto[@]santpau.cat
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The COVID19 pandemic is having an immeasurable impact on the economy and on morbidity and mortality. Knowledge and scientific evidence about this disease is advancing rapidly, but it is not yet known whether asthmatic patients suffering from COVID19 have an exacerbation of asthma, or whether this viral infection has an impact on control and lung function in the short to medium term. The aim of this study is to define the changes that occur in these two parameters in asthmatic patients suffering from COVID19. To this end, asthmatic patients who have suffered a SARS-CoV-2 infection and who have required an emergency consultation or hospitalisation will be collected in a pneumology consultation and matched by age, sex and severity of asthma with a group that has not suffered the same. Both will be followed for one year, and lung function will be tested at six months and exacerbations and changes in ACT during the following year. These data are intended to improve the available knowledge on the impact of IDVC19 on asthma patients with a view to making appropriate recommendations, prevention and treatment adjustments in line with the results obtained.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 1, 2024
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 80 Years

Eligibility

Inclusion Criteria:

• 12 -80 years
• Asthma diagnosis according to guidelines
• Follow up on asthma clinics in one of the participant hospitals

Exclusion Criteria:

• Other severe respiratory condition independent of asthma

Related Conditions & MeSH terms

• Asthma
• COVID-19
• Covid19

Intervention

Diagnostic Test:
• spirometry
Lung function test: pre and post bronchodilator spirometry

Other:
• Asthma control test
Asthma control test

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	Sociedad Española de Neumología y Cirugía Torácica

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma control	Change in score of Asthma Control Test (ACT). Min 5 máx 25 (the higher score indicates better control)	6 months
Secondary	Asthma function	Change in FEV1 (Forced expiratory volume in one second)	6 months