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Clinic Versus Home Spirometry (COMPAIR)

Primary Purpose

Asthma, Chronic Obstructive Pulmonary Disease

Status

Recruiting

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

NuvoAir Air Next spirometer

About this trial

This is an interventional other trial for Asthma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Respiratory Research UnitRecruiting
Bradford Teaching Hospitals NHS Foundation Trust
The Rotherham NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Clinic vs Home spirometry

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT05219773

First Posted

September 28, 2021

Last Updated

January 20, 2022

Sponsor

University of Nottingham

Collaborators

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT05219773

Brief Title

Clinic Versus Home Spirometry

Acronym

COMPAIR

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Recruiting

Study Start Date

December 14, 2021 (Actual)

Primary Completion Date

April 2022 (Anticipated)

Study Completion Date

May 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Nottingham

Collaborators

AstraZeneca

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma, Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Clinic vs Home spirometry

Arm Type

Other

Arm Description

Intervention Type

Device

Intervention Name(s)

NuvoAir Air Next spirometer

Intervention Description

Primary Outcome Measure Information:

Title

1. To compare spirometric values obtained from the NuvoAir Air Next device, directly supervised in clinic and virtually supervised in clinic and at home.

Description

Time Frame

8 days

Title

2. To compare spirometric values obtained from two virtually supervised tests performed at home, using the NuvoAir Air Next device.

Description

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.

Time Frame

8 days

Secondary Outcome Measure Information:

Title

To evaluate the participant's views of home spirometry via a survey.

Description

A standardised survey to evaluate the participant's perception of home spirometry, will be performed.

Time Frame

8 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ashish Pradhan

Phone

07816 097200

ashish.pradhan@nottingham.ac.uk

First Name & Middle Initial & Last Name or Official Title & Degree

Nicola Neesham

Phone

07816 097200

nicola.neesham@nuh.nhs.uk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Professor Harrison

Organizational Affiliation

University of Nottingham

Official's Role

Principal Investigator

Facility Information:

Facility Name

Respiratory Research Unit

City

Nottingham

State/Province

Nottinghamshire

ZIP/Postal Code

NG51PB

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nicola Neesham

nicola.neesham@nuh.nhs.uk

First Name & Middle Initial & Last Name & Degree

Ashish Pradhan, MBBS

ashish.pradhan@nottinhgam.ac.uk

First Name & Middle Initial & Last Name & Degree

Ashish Pradhan, MBBS

Facility Name

Bradford Teaching Hospitals NHS Foundation Trust

City

Bradford

ZIP/Postal Code

BD9 6RJ

Country

United Kingdom

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Karen Regan

Karen.Regan@bthft.nhs.uk

First Name & Middle Initial & Last Name & Degree

Dinesh Saralaya, MBBS

Facility Name

The Rotherham NHS Foundation Trust

City

Rotherham

ZIP/Postal Code

S60 2UD

Country

United Kingdom

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ferzanah Salim

Phone

01709 426063

ferzanah.salim@nhs.net

First Name & Middle Initial & Last Name & Degree

Jacqueline Pollington

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

https://www.nrru.org/asthma-research

Description

The public website of Nottingham Respiratory Research Unit

Learn more about this trial

Clinic Versus Home Spirometry

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