Impact of COVID19 on Asthma Patients in Spain

NCT05064501 | Withdrawn

• 1 other identifier: IIBSP-COV-2020-129
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Asthma; Covid19

Keywords

asthma; asthma control; COVID19

Outcome Measures

Primary Outcomes (1)

• Asthma control

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

  6 months

Secondary Outcomes (1)

• Asthma function

  6 months

Study Arms (2)

Asthma and COVID19 infection

Asthma and COVID19 infection

Diagnostic Test: spirometry; Other: Asthma control test

Asthma without COVID19 infection

Asthma and COVID19 infection

Diagnostic Test: spirometry; Other: Asthma control test

Interventions

spirometry DIAGNOSTIC_TEST

Lung function test: pre and post bronchodilator spirometry

Asthma and COVID19 infection; Asthma without COVID19 infection

Asthma control test OTHER

Asthma control test

Asthma and COVID19 infection; Asthma without COVID19 infection

Eligibility Criteria

• Age: 12 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Other severe respiratory condition independent of asthma

Sponsors & Collaborators

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

Study Sites (2)

Hospital de la Santa Creu i Sant Pau. Carrer Mas Casanovas 90.

Barcelona, 08041, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

MeSH Terms

Conditions

Asthma; COVID-19

Interventions

Spirometry

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Intervention Hierarchy (Ancestors)

Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• elena Curto, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2021
• First Posted: October 1, 2021
• Study Start: February 1, 2021
• Primary Completion: February 1, 2023
• Study Completion: June 1, 2024
• Last Updated: November 18, 2025

Record last verified: 2022-08

Locations

ES (2)