Asthma Diagnosis Verified by Lung Function

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

Interventions

DIAGNOSTIC_TEST

AsthmaTuner

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).

Sponsors & Collaborators

• Region Stockholm

  collaborator OTHER_GOV

• MediTuner AB

  collaborator UNKNOWN

• Björn Nordlund

  lead OTHER

Principal Investigators

• Björn Nordlund, PhD and associate professor · Karolinska Institutet, Women's and Children's Health

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

6 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-12-01

Primary Completion

2023-05-01

Completion

2023-10-01

Countries

• Sweden

Study Locations