Clinic Versus Home Spirometry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-14

Study Completion Date

2022-05-31

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.

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Detailed Description

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Conditions

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Asthma Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Clinic vs Home spirometry

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.

Group Type OTHER

NuvoAir Air Next spirometer

Intervention Type DEVICE

* 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.

Interventions

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NuvoAir Air Next spirometer

* 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.

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No