Uncontrolled Postviral Asthma and Persistent Symptoms Aft... | NCT05919004

Studies
Uncontrolled Postviral Asthma and Persistent Symptoms After COVID-19

NCT05919004

Sponsor

The Norwegian Sports Medicine Centre - Football Association, Oslo, Norway

Status

Completed

Last Update Posted

Jun 28, 2023Actual

Enrollment

30Actual

Phase

Not provided

Conditions

Long COVID

Interventions

App-based spirometer

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2022Actual

Primary Completion Date

Nov 1, 2022Actual

Completion Date

Dec 31, 2022Actual

First Submitted Date

Jun 22, 2023

First Submission Date that Met QC Criteria

Jun 22, 2023

First Posted Date

Jun 26, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 27, 2023

Last Update Posted Date

Jun 28, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tonje Reier-Nilsen, MD PhD, The Norwegian Sports Medicine Centre - Football Association, Oslo, NorwayPrincipal Investigator

Lead Sponsor

The Norwegian Sports Medicine Centre - Football Association, Oslo, NorwayOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
App-based spirometer	Diagnostic Test	App-based spirometer to perform serial spirometry to assess lung function variatione

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Excessive lung function variation	Lung function given as FEV1.	8 months
Perceived symptoms of long covid	On a Likert scale 1-10	8 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

° Patients with long covid for more than 6 months referred for physical rehabilitation

Exclusion Criteria:

° None

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with long covid for more than 6 months

Sampling Method

Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000094024	Post-Acute COVID-19 Syndrome
D004194	Disease

Ancestor Terms

ID	Term
D000086382	COVID-19
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections

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Browse Branches

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