Asthma Diagnosis Verified by Lung Function

NCT04652141 | Completed DMC

• 1 other identifier: ADVERT.v.8
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief Summary

Guidelines suggests that asthma should not be treated prior to a reversibility test and/or an assessment with peak expiratory flow (PEF) unless there is a clinical urgency for the patient to be treated. Approximately one third of patients with diagnosed asthma can safely step-wise withdraw their asthma medication and diagnosis based on repeated objective lung function measurements. AsthmaTuner is CE-marked and provides doctors and nurses with information on patient spirometry incl. reversibility test and diurnal or weekly variability of PEF in relation perceived symptoms. Thereby, digital supported asthma care with AsthmaTuner can improve objective diagnosis of asthma. The objectives of this study are to evaluate the sensitivity and specificity to establish objective asthma diagnosis with spirometry including reversibility test and PEF-monitoring with AsthmaTuner, and secondary, assess the number of asthma patients with objective verified asthma diagnosis with use of spirometry including reversibility test and/or periodic variability with PEF/FEV1 between traditional trial treatment and treatment with AsthmaTuner. At least 146 patients will be included who are at least six years old, with respiratory symptoms that can be signed to asthma last month or with physician-diagnosed asthma last five years without intake of anti-inflammatory treatment in the last three months. This is a randomised controlled trial evaluating a diagnostic two step algorithm that firstly includes dynamic spirometry with a reversibility test and PEF/FEV1 monitoring with AsthmaTuner during 2-4 weeks, and secondly randomization to traditional trial treatment with dynamic spirometry with a reversibility test, or AsthmaTuner incl. PEF/FEV1 monitoring during trial treatment. We plan to include in total 146 patients in primary care with either undiagnosed asthma having respiratory symptoms that can be signed to asthma last month, or patients with a asthma diagnosis last 5 years but no intake of regular anti-inflammatory asthma medication last 3 months. The study start in early 2021 and finish in 2023.

Conditions

Asthma; Dyspnea; Asthmatic; Diagnoses Disease

Keywords

AsthmaTuner; Asthma; Spirometry; Peak Expiratory Flow Meter - PEF

Outcome Measures

Primary Outcomes (3)

• AsthmaTuner - daily PEF/FEV1 monitoring

  Objectively verified asthma/current asthma is defined as PEF/FEV1 diurnal variability of ≥10% and weekly/periodic variability of ≥20%.

  Up to 2-4 weeks recording

• Spirometry with reversibility test

  A change from baseline FEV1 of at least 12% and 200 ml will define positive reversibility with spirometry.

  The change from baseline FEV1 to post bronchodilator FEV1 at visit one

• Spirometry with reversibility test after trial treatment

  A change of FEV1 of at least 12% and 200 ml will define positive reversibility

  The change of FEV1 prior to trial treatment up to 3 months after trial treatment at end visit.

Secondary Outcomes (1)

• Periodic variability FEV1 during trial treatment with AsthmaTuner

  Up to 3 months after start of trial treatment

Study Arms (2)

AsthmaTuner field tests

ACTIVE COMPARATOR

Trail treatment with AsthmaTuner up to 3 months. Objective asthma criteria: Positive reversibility test, FEV1 \>12% and 200 ml or positive periodic variability PEF/FEV1 \>20%. Treatment recommendation is prescribed individually by treating physician.

Diagnostic Test: AsthmaTuner

Traditional trial treatment

NO INTERVENTION

Treatment recommendation is prescribed individually to patient by treating physician. The treatment plan is transferred to patient on printed paper and/or oral communication.

Interventions

AsthmaTuner DIAGNOSTIC_TEST

AsthmaTuner consists of a treatment-adjusting algorithm that gives patient immediate feedback on the status of symptom control (i.e. controlled, partly controlled or uncontrolled) and a treatment recommendation with an image of the correct inhaler or other type of medication and the dose based on lung function (FEV1) and symptom scores (0-4 points).

AsthmaTuner field tests

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of respiratory symptoms that can be signed to asthma last month or
• Only doctor diagnosed asthma last five years

You may not qualify if:

• Daily intake of asthma control medication
• Use of oral corticosteroids
• Pregnancy, breast feeding
• Inability to perform spirometry
• A contraindication of a severe a medical condition, i.e. heart failure or aorta or cerebral aneurysm or history of myocardial infarction or stroke within three months
• Smoking history greater than ten pack-years (possible COPD).

Sponsors & Collaborators

• Björn Nordlund: lead
• Region Stockholm: collaborator
• MediTuner AB: collaborator

Study Sites (1)

Region Stockholm

Stockholm, Sweden

Location

MeSH Terms

Conditions

Asthma; Dyspnea

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Björn Nordlund, PhD and associate professor

  Karolinska Institutet, Women's and Children's Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The randomization procedure will be masked to investigator by study nurse.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD RN

Model Details: Randomization (1:1) to trial treatment with either AsthmaTuner or traditional during 3 months.

Study Record Dates

• First Submitted: September 3, 2020
• First Posted: December 3, 2020
• Study Start: December 1, 2020
• Primary Completion: May 1, 2023
• Study Completion: October 1, 2023
• Last Updated: August 26, 2025

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)