AsthmaCOMPAIRNCT05219773
Clinic Versus Home Spirometry
A study testing NuvoAir Air Next spirometer in people with Asthma and Chronic Obstructive Pulmonary Disease, run by University of Nottingham at 3 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Asthma, Chronic Obstructive Pulmonary Disease
- What is being tested?
- NuvoAir Air Next spirometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 14 Dec 2021to May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- An ability to provide fully informed consent.
- A diagnosis of asthma or COPD.
- Male or female aged ≥18 and ≤ 80 years of age.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites, 3 recruiting
- Not yet recruiting
Bradford Teaching Hospitals NHS Foundation Trust
Bradford, BD9 6RJ
Karen Regan, Karen.Regan@bthft.nhs.uk
Dinesh Saralaya, MBBS
- Recruiting
Respiratory Research Unit
Nottingham, Nottinghamshire, NG51PB
Nicola Neesham, nicola.neesham@nuh.nhs.uk
Ashish Pradhan, MBBS, ashish.pradhan@nottinhgam.ac.uk
- Not yet recruiting
The Rotherham NHS Foundation Trust
Rotherham, S60 2UD
Ferzanah Salim, 01709 426063, ferzanah.salim@nhs.net
Jacqueline Pollington
About this study
Official title: 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.
- Conditions
- Asthma, Chronic Obstructive Pulmonary Disease
- Being tested
- NuvoAir Air Next spirometer
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: NuvoAir Air Next spirometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 8 days
Secondary outcomes (1)
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.
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start14 Dec 2021
- Primary completionApr 2022 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Professor Harrison, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05219773
- Sponsor's protocol ID
- 288594
- Acronym
- COMPAIR
- Status last verified
- Jan 2022
- First submitted
- 28 Sep 2021
- Last updated
- 2 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Clinic-based Versus Home-based Spirometry.
- ClinicalTrials.gov ID
- NCT05219773
- Acronym / sponsor ID
- COMPAIR / 288594
- Conditions
- Asthma, Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 14 Dec 2021 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 2 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clinic vs Home spirometry | Other | Device: NuvoAir Air Next spirometerThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- An ability to provide fully informed consent.
- A diagnosis of asthma or COPD.
- Male or female aged ≥18 and ≤ 80 years of age.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Clinic vs Home spirometry |
Primary outcome
1. To compare spirometric values obtained from the NuvoAir Air Next device, directly supervised in clinic and virtually supervised in clinic and at home.
Time frame: 8 days
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.
Time frame: 8 days
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.
1 secondary outcome
To evaluate the participant's views of home spirometry via a survey.
Time frame: 8 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2022.
- Individual participant dataSharing planned: No
Related trials for Asthma
RecruitingObservational study
Asthma and Primary Arterial Hypertension: an Inflammatory Link?
Asthma Bronchial
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Severe Asthma
Asthma
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 2
Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids
Asthma
Active, not recruitingPhase 1
A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating AMG 691 in Healthy Participants and Participants With Mild-to-Moderate Asthma
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Professor Harrison principal investigator
University of Nottingham
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NuvoAir Air Next spirometer in people with Asthma and Chronic Obstructive Pulmonary Disease, run by University of Nottingham at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ashish Pradhan (07816 097200, ashish.pradhan@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. To compare spirometric values obtained from the NuvoAir Air Next device, directly supervised in clinic and virtually supervised in clinic and at home. (time frame: 8 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2022.