Long COVIDCOVID-19NCT05919004
Uncontrolled Postviral Asthma and Persistent Symptoms After COVID-19
An observational study of Long COVID, run by The Norwegian Sports Medicine Centre - Football Association, Oslo, Norway at 1 site in Norway.
Trial summary
Patients with long covid referred for physical rehabilitation at the Norwegian Sports Medicine Centre - Football Association in Oslo, Norway, were assessed for postviral asthma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Long COVID
- What is being tested?
- App-based spirometer
- How many people
- 30 participants
- Where
- 1 siteNorway
- Study dates
- 1 May 2022to 31 Dec 2022
- 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 18 to 70 years
- All sexes
- Adult, Older adult
Study population: Patients with long covid for more than 6 months
Who may be able to join
- ° Patients with long covid for more than 6 months referred for physical rehabilitation
Who cannot join
- ° None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Uncontrolled Postviral Asthma in Patients With Long Covid
Patients with long covid referred for physical rehabilitation at the Norwegian Sports Medicine Centre - Football Association in Oslo, Norway, were assessed for postviral asthma.
Read the detailed description
All patients performed methacholin bronchial provocation test, and those with a negative bronchial provocation were eqipped with an app-based spirometer to detect excessive lung variability. Eventual detection of postviral asthma will be treated according to GINA guidelines and eventual effect will be assessed by lung function variability and symptoms.
- Conditions
- Long COVID
- Being tested
- App-based spirometer
- Keywords
- postviral asthma, diagnosis, long covid, telemedicine, lung function, digital spirometer
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
App-based spirometerDiagnostic test
App-based spirometer to perform serial spirometry to assess lung function variatione
What is being measured
The primary outcome is the main question the study is designed to answer.
Excessive lung function variation
Lung function given as FEV1.
Measured: 8 months
Perceived symptoms of long covid
On a Likert scale 1-10
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start1 May 2022
- Primary completion1 Nov 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVIDStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Norwegian Sports Medicine Centre - Football Association, Oslo, Norway
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tonje Reier-Nilsen, The Norwegian Sports Medicine Centre - Football Association, Oslo, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05919004
- Sponsor's protocol ID
- IdrettensHelsesenter
- Acronym
- COVID-19
- Status last verified
- Jun 2023
- First submitted
- 22 Jun 2023
- Last updated
- 28 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uncontrolled Postviral Asthma in Patients With Long Covid
- ClinicalTrials.gov ID
- NCT05919004
- Acronym / sponsor ID
- COVID-19 / IdrettensHelsesenter
- Conditions
- Long COVID
- Keywords
- postviral asthma, diagnosis, long covid, telemedicine, lung function, digital spirometer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The Norwegian Sports Medicine Centre - Football Association, Oslo, NorwayUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 26 Jun 2023 (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.
Patients with long covid referred for physical rehabilitation at the Norwegian Sports Medicine Centre - Football Association in Oslo, Norway, were assessed for postviral asthma.
Detailed description
All patients performed methacholin bronchial provocation test, and those with a negative bronchial provocation were eqipped with an app-based spirometer to detect excessive lung variability. Eventual detection of postviral asthma will be treated according to GINA guidelines and eventual effect will be assessed by lung function variability and symptoms.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with long covid for more than 6 months
Key inclusion criteria (1 listed)
- ° Patients with long covid for more than 6 months referred for physical rehabilitation
Key exclusion criteria (1 listed)
- ° None
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 |
|---|---|---|
| App-based spirometerApp-based spirometer to perform serial spirometry to assess lung function variatione | Diagnostic test | – |
Primary outcome
Excessive lung function variation
Time frame: 8 months
Lung function given as FEV1.
Perceived symptoms of long covid
Time frame: 8 months
On a Likert scale 1-10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Long COVID, run by The Norwegian Sports Medicine Centre - Football Association, Oslo, Norway at 1 site in Norway.
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 1 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: finished, as of the sponsor's last update on 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Excessive lung function variation (time frame: 8 months). The study lists 2 primary outcomes in all. 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 28 Jun 2023.