Impact of COVID19 on Asthma Patients in Spain (IMCAS)

Impact of COVID19 on Lung Function and Control of Asthma Patients

This research project aims to investigate the impact of COVID-19 on asthmatic patients, particularly focusing on whether the viral infection exacerbates asthma or affects control and lung function in the short to medium term. The study plans to collect and compare data from two groups of asthmatic individuals - those who have experienced a SARS-CoV-2 infection requiring emergency consultation or hospitalization and a matched control group without such infection. Both groups will be followed for one year, with lung function tests conducted at six months and monitoring of exacerbations and changes in Asthma Control Test (ACT) throughout the year. The objective is to enhance understanding of how COVID-19 affects asthmatic patients, leading to improved recommendations, preventive measures, and treatment adjustments based on the study's findings.

Study Overview

• Status: Withdrawn
• Conditions: Covid19; Asthma
• Intervention / Treatment: Diagnostic test: spirometry; Other: Asthma control test

Detailed Description

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.

• Study Type: Observational

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08041
    • Hospital De La Santa Creu I Sant Pau
  • Barcelona, Spain, 08041
    • Hospital de la Santa Creu i Sant Pau. Carrer Mas Casanovas 90.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients between the ages of 12 and 80 diagnosed with asthma according to current guidelines (GEMA/GINA), of any level of severity, will be recruited and followed up in Pneumology consultations at participating hospitals. The study cohort would be patients with these criteria who have needed to consult the Emergency Department or be admitted for COVID19 (suggestive symptomatology + CRP and/or positive serology) in the six months prior to the visit. The control group would be a cohort of asthmatic patients matched by age, severity and sex, who have not suffered COVID19 or compatible symptoms.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asthma control	Change in score of Asthma Control Test (ACT). Min 5 máx 25 (the higher score indicates better control)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asthma function	Change in FEV1 (Forced expiratory volume in one second)	6 months

Collaborators and Investigators

• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Collaborators: Sociedad Española de Neumología y Cirugía Torácica
• Investigators: Principal Investigator: elena Curto, PhD, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Estimated): February 1, 2023
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: September 30, 2021
• First Submitted That Met QC Criteria: September 30, 2021
• First Posted (Actual): October 1, 2021

Study Record Updates

• Last Update Posted (Estimated): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: asthma; COVID19; asthma control
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Asthma; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Respiratory System; Respiratory Function Tests; Spirometry
• Other Study ID Numbers: IIBSP-COV-2020-129

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No