Clinic Versus Home Spirometry

Study Overview
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Brief Summary
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The study aims to assess the differences between spirometry performed with the NuvoAir Air Next spirometer in the clinic setting with both direct and virtual supervision via a video call, and in the home setting with virtual supervision. This is will be achieved by comparing lung function values, specifically the FEV1 and FVC measurements. We also wish to evaluate participant's perceptions of home spirometry, by using a survey. This is a multi-centre, cross-over study. The study will enrol participants with a diagnosis of asthma and COPD, across participating study sites until 68 have completed the study.

Official Title
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A Comparison of Clinic-based Versus Home-based Spirometry.

Conditions
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Asthma, Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Device: NuvoAir Air Next spirometer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: An ability to provide fully informed consent. A diagnosis of asthma or COPD. Male or female aged ≥18 and ≤ 80 years of age. Exclusion Criteria: Symptoms suggestive of COVID-19. An exacerbation of asthma or COPD or symptoms of a respiratory infection within the 30 days prior to the first visit. Any other clinically significant medical disease or uncontrolled concomitant disease, that is likely, in the opinion of the Investigator(s), to impact on the ability to participate in the study. The presence of any contraindications to spirometry.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Clinic vs Home spirometry<br>The collection of medical history and demographic data Spirometry testing in both the clinic and home setting. The measurement of height and weight. The evaluation of the perception of home spirometry via a survey. | Device: NuvoAir Air Next spirometer<br>* The collection of medical history and demographic data Spirometry testing in both the clinic and home setting. The measurement of height and weight. The evaluation of the perception of home spirometry via a survey.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. To compare spirometric values obtained from the NuvoAir Air Next device, directly supervised in clinic and virtually supervised in clinic and at home. | Over an 8-day period; the forced expiratory volume in 1 second (FEV1) and forced vital Capacity (FVC) will be measured at 4 points in the study over the 8 day study period. Twice in clinic and twice at home. | 8 days | 
| 2. To compare spirometric values obtained from two virtually supervised tests performed at home, using the NuvoAir Air Next device. | The forced expiratory volume in 1 second (FEV1) and forced vital Capacity (FVC) will be measured via the NuvoAir Air Next spirometer at home at 2 points during the 8 day study period. | 8 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the participant's views of home spirometry via a survey. | A standardised survey to evaluate the participant's perception of home spirometry, will be performed. | 8 days |