IMCAS proyect: Impact of COVID19 on Asthma

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (Other)

Overall Status

Recruiting

CT.gov ID

NCT05064501

Collaborator

Sociedad Española de Neumología y Cirugía Torácica (Other)

100

Enrollment

Location

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Asthma Covid19	Diagnostic Test: spirometry Other: Asthma control test

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

100 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Impact of COVID19 on Lung Function and Control of Asthma Patients

Actual Study Start Date :

Feb 1, 2021

Anticipated Primary Completion Date :

Feb 1, 2023

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Asthma and COVID19 infection Asthma and COVID19 infection	Diagnostic Test: spirometry Lung function test: pre and post bronchodilator spirometry Other: Asthma control test Asthma control test
Asthma without COVID19 infection Asthma and COVID19 infection	Diagnostic Test: spirometry Lung function test: pre and post bronchodilator spirometry Other: Asthma control test Asthma control test

Arm

Intervention/Treatment

Asthma and COVID19 infection

Diagnostic Test: spirometry

Lung function test: pre and post bronchodilator spirometry

Other: Asthma control test

Asthma control test

Asthma without COVID19 infection

Asthma and COVID19 infection

Diagnostic Test: spirometry

Lung function test: pre and post bronchodilator spirometry

Other: Asthma control test

Asthma control test

Outcome Measures

Primary Outcome Measures

Asthma control [6 months]
Change in score of Asthma Control Test (ACT). Min 5 máx 25 (the higher score indicates better control)

Secondary Outcome Measures

Asthma function [6 months]
Change in FEV1 (Forced expiratory volume in one second)

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital de la Santa Creu i Sant Pau	Barcelona		Spain	08041

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

ClinicalTrials.gov Identifier:

NCT05064501

Other Study ID Numbers:

IIBSP-COV-2020-129

First Posted:

Oct 1, 2021

Last Update Posted:

Aug 5, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

asthma

asthma control

COVID19

Additional relevant MeSH terms:

COVID-19

Asthma

Study Results

No Results Posted as of Aug 5, 2022