Clinic Versus Home Spirometry (COMPAIR)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Obstructive Pulmonary Disease; Asthma
• Intervention / Treatment: Device: NuvoAir Air Next spirometer

• Study Type: Interventional
• Enrollment (Anticipated): 68
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ashish Pradhan; Phone Number: 07816 097200; Email: ashish.pradhan@nottingham.ac.uk
• Study Contact Backup: Name: Nicola Neesham; Phone Number: 07816 097200; Email: nicola.neesham@nuh.nhs.uk

Study Locations

• United Kingdom
  • Bradford, United Kingdom, BD9 6RJ
    • Not yet recruiting
    • Bradford Teaching Hospitals NHS Foundation Trust
    • Contact: Karen Regan; Email: Karen.Regan@bthft.nhs.uk
    • Principal Investigator: Dinesh Saralaya, MBBS
  • Rotherham, United Kingdom, S60 2UD
    • Not yet recruiting
    • The Rotherham NHS Foundation Trust
    • Contact: Ferzanah Salim; Phone Number: 01709 426063; Email: ferzanah.salim@nhs.net
    • Principal Investigator: Jacqueline Pollington
  • Nottinghamshire
    • Nottingham, Nottinghamshire, United Kingdom, NG51PB
      • Recruiting
      • Respiratory Research Unit
      • Contact: Nicola Neesham; Email: nicola.neesham@nuh.nhs.uk
      • Contact: Ashish Pradhan, MBBS; Email: ashish.pradhan@nottinhgam.ac.uk
      • Principal Investigator: Ashish Pradhan, MBBS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Nottingham
• Collaborators: AstraZeneca
• Investigators: Principal Investigator: Professor Harrison, University of Nottingham

Publications and helpful links

Helpful Links

• The public website of Nottingham Respiratory Research Unit

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2021
• Primary Completion (Anticipated): April 1, 2022
• Study Completion (Anticipated): May 1, 2022

Study Registration Dates

• First Submitted: September 28, 2021
• First Submitted That Met QC Criteria: January 20, 2022
• First Posted (Actual): February 2, 2022

Study Record Updates

• Last Update Posted (Actual): February 2, 2022
• Last Update Submitted That Met QC Criteria: January 20, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 288594

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No