Clinic Versus Home Spirometry

Asthma Clinical Trial

— COMPAIR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05219773
• Other study ID #: 288594
• Status: Recruiting
• Phase: N/A
• Start date: December 14, 2021
• Est. completion date: May 2022

Study information

• Verified date: January 2022
• Source: University of Nottingham
• Contact: Ashish Pradhan
• Phone: 07816 097200
• Email: ashish.pradhan[@]nottingham.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: May 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United Kingdom	Bradford Teaching Hospitals NHS Foundation Trust	Bradford
United Kingdom	Respiratory Research Unit	Nottingham	Nottinghamshire
United Kingdom	The Rotherham NHS Foundation Trust	Rotherham

Sponsors (2)

Lead Sponsor	Collaborator
University of Nottingham	AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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

External Links

•   The public website of Nottingham Respiratory Research Unit