NCT04652141: ADVERT

Asthma Diagnosis Verified by Lung Function

Completed NA Last updated 26 August 2025

What this trial tests

NA trial testing AsthmaTuner in Asthma in 146 participants. Completed in 1 October 2023.

Timeline

1 December 2020

Primary endpoint
1 May 2023

1 October 2023

Quick facts

Lead sponsor	Björn Nordlund
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	diagnostic
Enrollment	146
Start date	1 December 2020
Primary completion	1 May 2023
Estimated completion	1 October 2023
Sites	1 location across Sweden

Drugs / interventions tested

• AsthmaTuner

Conditions studied

• Asthma — all drugs for Asthma →
• Dyspnea; Asthmatic — all drugs for Dyspnea; Asthmatic →
• Diagnoses Disease — all drugs for Diagnoses Disease →

Sponsor

Björn Nordlund

Who can join

6 and older, any sex, with Asthma or Dyspnea; Asthmatic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Assessing diagnostic accuracy for asthma with home spirometry in primary care.
   Myers L, Bellander M, Ljungberg H, Isachsen M, et al · · 2025 · PMID 41453875 · DOI 10.1038/s41533-025-00471-5