NCT05219773

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P25-P50 for not_applicable asthma

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable asthma

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

December 14, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 2, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

February 2, 2022

Status Verified

January 1, 2022

Enrollment Period

4 months

First QC Date

September 28, 2021

Last Update Submit

January 20, 2022

Conditions

AsthmaChronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

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

    8 days

Study Arms (1)

Clinic vs Home spirometry

OTHER

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

Interventions

NuvoAir Air Next spirometerDEVICE

* 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.

Clinic vs Home spirometry

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • An ability to provide fully informed consent.
  • A diagnosis of asthma or COPD.
  • Male or female aged ≥18 and ≤ 80 years of age.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Respiratory Research Unit

Nottingham, Nottinghamshire, NG51PB, United Kingdom

RECRUITING

Bradford Teaching Hospitals NHS Foundation Trust

Bradford, BD9 6RJ, United Kingdom

NOT YET RECRUITING

The Rotherham NHS Foundation Trust

Rotherham, S60 2UD, United Kingdom

NOT YET RECRUITING

Related Links

MeSH Terms

Conditions

AsthmaPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Professor Harrison

    University of Nottingham

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashish Pradhan

CONTACT

07816 097200ashish.pradhan@nottingham.ac.uk

Nicola Neesham

CONTACT

07816 097200nicola.neesham@nuh.nhs.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2021

First Posted

February 2, 2022

Study Start

December 14, 2021

Primary Completion

April 1, 2022

Study Completion

May 1, 2022

Last Updated

February 2, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

GB(3)