AsthmaIMCASNCT05064501
Impact of COVID19 on Asthma Patients in Spain
An observational study of Asthma and Covid19, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 80 years
- What is being tested?
- spirometry
- How many people
- 0 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Feb 2021to 1 Jun 2024
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 12 -80 years
- Asthma diagnosis according to guidelines
- Follow up on asthma clinics in one of the participant hospitals
Who cannot join
- Other severe respiratory condition independent of asthma
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital de la Santa Creu i Sant Pau. Carrer Mas Casanovas 90.
Barcelona, 08041
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
About this study
Official title: 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.
Read the 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.
- Being tested
- spirometry, Asthma control test
- Keywords
- asthma, asthma control, COVID19
- Medical subject headings
- Asthma, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spirometryDiagnostic test
Lung function test: pre and post bronchodilator spirometry
Asthma control testOther
Asthma control test
| Study group | Role | What they receive |
|---|---|---|
| Asthma and COVID19 infection | Asthma and COVID19 infection Receives: Diagnostic Test: spirometry; Other: Asthma control test | |
| Asthma without COVID19 infection | Asthma and COVID19 infection Receives: Diagnostic Test: spirometry; Other: Asthma control test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma control
Change in score of Asthma Control Test (ACT). Min 5 máx 25 (the higher score indicates better control)
Measured: 6 months
Secondary outcomes (1)
Asthma function
Change in FEV1 (Forced expiratory volume in one second)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start1 Feb 2021
- Primary completion1 Feb 2023 (estimated)
- Study completion1 Jun 2024 (estimated)
Why it stopped: Difficulty in recruiting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Sociedad Española de Neumología y Cirugía Torácica
- Responsible party
- Sponsor
- Investigators
- elena Curto, PhD, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05064501
- Sponsor's protocol ID
- IIBSP-COV-2020-129
- Acronym
- IMCAS
- Status last verified
- Aug 2022
- First submitted
- 30 Sep 2021
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of COVID19 on Lung Function and Control of Asthma Patients
- ClinicalTrials.gov ID
- NCT05064501
- Acronym / sponsor ID
- IMCAS / IIBSP-COV-2020-129
- Keywords
- asthma, asthma control, COVID19
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Difficulty in recruiting
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Collaborators
- Sociedad Española de Neumología y Cirugía Torácica
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Feb 2023 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 1 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asthma and COVID19 infection | – | Diagnostic Test: spirometry, Other: Asthma control testAsthma and COVID19 infection |
| Asthma without COVID19 infection | – | Diagnostic Test: spirometry, Other: Asthma control testAsthma and COVID19 infection |
Who may qualify
- Ages
- 12 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 12 -80 years
- Asthma diagnosis according to guidelines
- Follow up on asthma clinics in one of the participant hospitals
Key exclusion criteria (1 listed)
- Other severe respiratory condition independent of asthma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spirometryLung function test: pre and post bronchodilator spirometry | Diagnostic test | Asthma and COVID19 infection, Asthma without COVID19 infection |
| Asthma control testAsthma control test | Other | Asthma and COVID19 infection, Asthma without COVID19 infection |
Primary outcome
Asthma control
Time frame: 6 months
Change in score of Asthma Control Test (ACT). Min 5 máx 25 (the higher score indicates better control)
1 secondary outcome
Asthma function
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
elena Curto, PhD principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Covid19, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma control (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.