Completed

Spiro@HomeHome Spirometry for the Diagnosis and Monitoring of Asthma and COPD in Primary Care in The Netherlands and Sweden: an Implementation Study

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What is being collected

Data Collection

Collected at a single point in time - Cross-sectional
Who is being recruted

Over 16 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: September 2021
See protocol details

Summary

Principal SponsorGeneral Practitioners Research Institute
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 27, 2021

Actual date on which the first participant was enrolled.

Rationale: Spirometry is essential in the diagnosis of airway disease and can be useful in monitoring patients. Despite the essential role, spirometry remains largely underused in primary care. Due to Coronavirus disease (COVID-19), the use of office spirometry is contraindicated in many countries. Furthermore, spirometric devices are costly and personnel requires special training. Referral for spirometry increases the cost for patients and lowers the feasibility. Part of the reason for underdiagnosis of airway disease are the specific situations (such as exercise-induced asthma) in which spirometry in office setting might not reveal abnormalities. In recent years, handheld spirometry linked to phones/apps has been developed for study purposes and remote monitoring. Objective: To study the feasibility, quality and added value of at-home spirometry for the diagnosis and monitoring of asthma and Chronic Obstructive Pulmonary Disease (COPD) in primary care.

Official TitleHome Spirometry for the Diagnosis and Monitoring of Asthma and COPD in Primary Care in The Netherlands and Sweden: an Implementation Study
NCT05162157
Principal SponsorGeneral Practitioners Research Institute
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

144 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 16 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

3 inclusion criteria required to participate
Age ≥ 16 years

Spirometry indication

Able and willing to use at-home spirometry

4 exclusion criteria prevent from participating
On the discretion of the recruiting clinician if he or she deems a patient not eligible.

Inability to understand and sign the informed consent form

Known previous inability to perform spirometry

Contraindications to perform spirometry as listed in the standardization of Spirometry 2019 update (Graham et al., 2019)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

GPRI

Groningen, NetherlandsOpen GPRI in Google Maps
Suspended

Karolinska Institute

Solna, Sweden
Completed2 Study Centers